medical device daily - march 12, 2013

Tuesday, March 12, 201 3 Vol. 17, No. 48 of 1 1

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InsIde:Don’t miss today’s MDD Extra: Cardiology

MacuLogIx raIses $3.6M In ‘a’ funds for aMd dIagnostIc ........................ 2u.s. onLy days away froM syncIng Its patent ruLes ...................................... 3

European Congress of Radiology

GE, Philips are stalled in breast tomosynthesis but ready to flexBy JOHN BROSKYMedical Device Daily European Editor

VIENNA – It’s been another fine year for the established players in breast tomosynthesis as they were not troubled by the expected arrival of new systems from GE Healthcare (Chalfont, UK) and Royal Philips Electronics (Amsterdam, the Netherlands) (Medical Device Daily, Mar. 7, 2012).

GE is stuck in the starting gate waiting regulatory approval for the breast tomosynthesis upgrade option of the Senographe Essential platform.

Philips still has not made up its corporate mind about what to do, if anything, with the prototype it acquired last year along with the mammography business of Sectra Mamea (Stockholm).

The pioneer in this segment, Hologic (Bedford,

American College of Cardiology

Watchman data release saga puts soap opera plots to shame By LARRY HAIMOVITCHMedical Device Daily Contributing Writer

SAN FRANCISCO — The 62nd Annual Scientific Session of the American College of Cardiology (ACC; Bethesda, Maryland) kicked off here early on Saturday morning with a new and surprising turn in a series of unusual events that have surrounded the Prospective Randomized Evaluation of the Watchman LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy (PREVAIL) trial.

The results from PREVAIL, sponsored by Boston Scientific (BSC; Natick, Massachusetts), were arguably the most eagerly anticipated trial at this meeting. It was scheduled to be the first trial to be reported on the first day in the Late Breaking Clinical Trial session. Early in the week

ACC notebook

Abbott has long-term positiveresults from ABSORB trialBy OMAR FORDMedical Device Daily Staff Writer

Abbott (Abbott Park, Illinois) reported positive long-term results for the company’s Absorb Bioresorbable Vascular Scaffold (BVS). Three-year results from 101 patients in the second stage of the ABSORB trial were presented at the 62nd Annual Scientific Session of the American College of Cardiology (ACC; Bethesda, Maryland) in San Francisco.

“The data showed that the device is safe and effective,” Jonathon Hamilton, a spokesman for Abbott told Medical Device Daily. “There isn’t anything like ABSORB on the market. It’s a fully bioreabsorbable vascular scaffold that elutes a drug – similar to a drug-eluting stent . . . but the

Washington roundup

Medicare virtual colonoscopy bill introduced again in HouseBy MARK McCARTYMedical Device Daily Washington Editor

Medicare coverage of virtual colonoscopy has been a frequent topic over the past couple of years, and Rep. Ralph Hall (R-Texas) has reintroduced legislation that would mandate Medicare coverage of the procedure. Should the bill pass, the number of CT colonography procedures could skyrocket, which would translate into a substantial increase in Medicare spending in the short term, and could provide at least a modest up-tick in sales of CT hardware, given the tens of millions of Americans who will reach the age of Medicare eligibility over the next two decades.

Hall, along with co-sponsor Rep. Danny Davis (D-Illinois) offered H.R. 991 on March 6, a bill that will be vetted by the

See ACC, Page 6

See Abbott, Page 8 See Washington, Page 9

See ECR, Page 7

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Tuesday, March 12, 2013 Medical deVice daily™ of 1 1

Financings roundup

MacuLogix raises $3.6M in ‘A’ funds for AMD diagnosticA Medical Device Daily Staff Report

Coming Wednesdayin MDD Perspectives

Statistical tinkering in device regulation a disservice to patients

Despite the regulatory approval of new antiepileptic drugs (AED) over the past decade and the expansion of indications deemed suitable for epilepsy surgery, individuals with intractable seizures – roughly one in three epilepsy patients – still face a dearth of treatment options. To read more, see tomorrow’s edition of MDD Perspectives, an op-ed e-zine that provides fresh commentary from the MDD Perspectives blog, http://mdd.blogs.medicaldevicedaily.com. Plus, you’ll have access to free articles from Medical Device Daily. If you don’t already receive this complimentary e-zine, go to medicaldevicedaily.com to opt in.

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See Financings, Page 5

MacuLogix (Hummelstown, Pennsylvania) said it has raised $3.6 million in its Series A funding round. The company says it will use the funds to advance the development of its diagnostic for the early detection of age-related macular degeneration (AMD), a leading cause of adult blindness.

Investors include Berwind Private Equity, Roche Venture Fund, Life Sciences Greenhouse of Central Pennsylvania, and Ben Franklin Technology Partners of Central and Northern Pennsylvania.

The company is developing a technology called AdaptDx for early detection and tracking of AMD. According to MacuLogix, the AdaptDx will provide doctors with an easy-to-use, functional diagnostic similar to routine perimetry testing for glaucoma.

“MacuLogix represents a favorable investment opportunity as it addresses a large and growing market for AMD which is the leading cause of adult vision loss and blindness in developed countries,” said A. Laurence Norton, managing director of Berwind Private Equity. “We understand the AdaptDx has the potential to fundamentally transform the way eye doctors detect and manage AMD for millions of people worldwide.”

The AdaptDx has received FDA 510(k) clearance for measurement of dark adaptation function and patient testing has been completed to support validation as a diagnostic for AMD, MacuLogix noted. However, the device is not yet cleared for sale as a diagnostic. In addition, the company says the technology is being used by a number of pharmaceutical companies in the development of drugs for early AMD.

“Closing our Series A round is a very significant achievement for the company,” said John Edwards, CEO of MacuLogix. “We have completed numerous clinical studies involving more than 1,000 patients with additional studies ongoing, all at major research centers such as Harvard University, the National Eye Institute and University of Alabama at Birmingham. This financing allows us to take the next step.”

In other financing activity:• Lincor Solutions (Dublin, Ireland) said it has secured

a $9.5 million equity investment from Edison Ventures. The company expects to add over 30 positions in software development, sales, marketing, customer support and finance roles over the next year in Ireland and the U.S. Lincor’s MediVista platform delivers secure access to all patient data



See Patent, Page 4

U.S. only days away from syncing its patent rulesBy MARI SEREBROVMedical Device Daily Contributing Writer

Beginning next week, the U.S. patent system will be in step with the rest of the world. But to keep pace, the Patent and Trademark Office (PTO) and industry will have to manage a steep learning curve as the nation switches from first-to-invent patent claims to a globally accepted first-to-file system.

The switch, mandated by the America Invents Act (AIA), officially occurs Saturday, so it won’t affect applications that come in under the wire this week. Those claims will be handled according to the old rules, even though it could take the PTO nearly three years to process them.

Device makers who can’t file by Friday need “to have mechanisms in place to identify new inventions promptly and prioritize patent applications for preparation and filing,” Courtenay Brinckerhoff, a partner at Foley & Lardner LLP, told Medical Device Daily.

She advised them “to use provisional applications strategically and to ensure that all pre-filing disclosures, including offers for sale and sales anywhere in the world, are pre-screened for [intellectual property] purposes.”

One of the most challenging aspects of the AIA for device

makers is its broader definition of prior art, which could render a claim unpatentable. Under the new definition, prior art covers disclosures made by anyone, even the applicant, before the filing of a patent application. This would include public presentations at a device conference, even if there are no printed handouts. However, disclosures made by the patent applicant within a year of the filing date would be excluded.

Because of the expansion of prior art, it is even more important for a device maker’s provisional application to provide an adequate written description and enablement to support the priority date for any claimed subject matter, said Mary Sylvia, a patent attorney with BakerHostetler.

Under the new law, “there will be much more potential prior art that can be raised against a U.S. application,” Sylvia told MDD. “So although companies may want to rush to the patent office and be the first to file, unless they flesh out that provisional application with adequate support, the effort may be futile.”

Companies used to filing internationally should be able to take the changes in stride, Sylvia said, as other countries have had similar rules about prior art. The biggest impact could be to university technology transfer offices that don’t always succeed in trying to keep up with inventor’s publications, she added. Such failures in the future could impact a university’s patent portfolio and out-licensing

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Agreements/contracts

iCAD, Invio combine effortsin MRI solution technology A Medical Device Daily Staff Report

revenue.Just ahead of the switch, the PTO plans to hold a public

forum/webcast from 1-4 p.m. Friday to discuss the new rules.Meanwhile, many companies are heeding the advice of

patent experts and racing to get applications filed before the new definition of prior art goes into effect. In the past few months, the PTO has seen a steady increase in the number of new applications submitted. The office received about 100,000 new applications in November, more than 130,000 in December and about 170,000 in January, according to its performance dashboard.

Despite all the new applications, the PTO has whittled its backlog from a high of about 722,000 applications in December 2010 to slightly more than 593,000 applications last month. It’s done that by hiring more patent examiners and reducing the time to process claims.

As of February, the patent process from time of filing to final disposition was taking an average of about 31 months – so long as no request for continued examination (RCE) was involved. That average is down from more than 35 months in October 2010, but it’s still a long way from the PTO’s goal of 20 months, which the office hopes to hit in 2015.

More impressive is the reduction in time to first action. In October 2010, the PTO averaged more than 26 months from time of application to take its first action. In February, the wait was down to slightly more than 14 months.

But those numbers don’t tell the whole story, as more applications are being put in the RCE pile, where complex claims can get held up for months or even years. In November 2010, the PTO was averaging more than five years to handle an RCE. Now, it’s taking even longer, and the backlog of RCEs is growing. As of February, it had a backlog of nearly 112,000 RCEs, compared with about 42,000 in August 2010, shortly before the AIA was signed into law.

The PTO also is taking longer to handle appeals. In 2010, the average appeal – from time of initial filing of the application to a decision from the Board of Patent Appeals and Interferences – took more than six years. It’s now taking more than seven years, according to the PTO. n

PatentContinued from Page 3

Invivo (Gainesville, Florida) and iCAD (Nashua, New Hampshire), a provider of imaging and radiation therapy technologies for the detection and treatment of cancer, said the companies have entered into a global research, development, and commercial agreement.

Under the agreement, iCAD will develop advanced MRI image analysis software products which Invivo will incorporate into its suite of MRI product solutions for global commercial sale. The first products are anticipated to be available in Q2 2013. The initial focus of the partnership will be the release of a next generation platform for prostate and breast imaging. Additional new product releases are also anticipated beginning the second half of 2013.

Invivo makes innovative RF coils, advanced image visualization systems, and MRI-compatible interventional instruments.

iCAD is a leading provider of advanced image analysis, workflow solutions and radiation therapies for the early identification and treatment of common cancers.

In other agreements/contracts news: • The Cleveland Clinic (Cleveland) will lend its

expertise to the more than 130 hospitals in 29 states run by Community Health Systems (Franklin, Tennessee). CHS will gain access to a “quality alliance” already in place at the Cleveland Clinic that can electronically capture, report and compare data about patient outcomes; come up with predictive models for improving patient outcomes; and share those best practices across the CHS system.

As part of a five-year agreement, the organizations will focus on three areas. In addition to the quality alliance that focuses on physicians and data analysis, the Cleveland Clinic will work to improve cardiovascular services across the CHS system, which could lead to more referrals to Cleveland Clinic for tertiary care; and the two groups will work on common issues such as advancing telemedicine and reducing supply costs.

Both organizations will remain independent and the alliance will be guided by a coordinating council that will have equal representation from the Cleveland Clinic and CHS.

• Sanford-Burnham Medical Research Institute (La Jolla, California) and Mayo Clinic (Rochester, Minnesota) signed a new collaborative agreement to build a pipeline of therapeutic drugs aimed at a variety of diseases with serious unmet medical needs. Under this agreement, Mayo Clinic scientists will work with researchers in Sanford-Burnham’s Conrad Prebys Center for Chemical Genomics to conduct early-stage drug discovery, including assay development, high-throughput screening, and lead identification. Sanford-Burnham, an independent research institute, is recognized

for establishing novel collaborations with clinical organizations to expedite early-phase drug discovery.

The agreement combines Mayo Clinic’s clinically relevant targets with Sanford-Burnham’s discovery platform in a translational initiative aimed at advancing a portfolio of projects through the initial stages of drug discovery. The new agreement builds on a yearlong pilot phase and expands the number and scope of drug discovery projects derived from Mayo Clinic researchers that are being conducted at Sanford-Burnham.

Sanford-Burnham says it takes a collaborative approach to medical research with major programs in cancer, neurodegeneration, diabetes, and infectious, inflammatory, and childhood diseases. n



International report

St. Jude launches 3-D vesselreconstruction tech in Japan A Medical Device Daily Staff Report

Court report

German grants injunctionvs. Elan Med for infringementA Medical Device Daily Staff Report

FinancingsContinued from Page 2

at the hospital bedside enabling doctors and nurses to make accurate decisions based on real-time information. It also provides access to hospital management systems for patients and a range of interactive education, entertainment and communications services that improve outcomes.

• Aviv (Chicago), a real estate investment trust that specializes in owning post-acute and long-term care skilled nursing facilities and other healthcare properties, said it has launched an initial public offering of 13.2 million shares of its common stock. The estimated price range of the common stock is between $18 and $20 a share. The underwriters have the option to buy up to an additional 1,980,000 shares of common stock to cover overallotments, if any.

The company’s common stock has been approved for listing on the New York Stock Exchange under the symbol AVIV. Aviv says it intends to use the net proceeds from the offering to repay certain indebtedness and for general corporate purposes, including the potential acquisition of additional properties in the ordinary course of business.

Morgan Stanley, BofA Merrill Lynch and Goldman, Sachs & Co. are acting as joint book-running managers of the offering, and Citigroup, RBC Capital Markets, SunTrust Robinson Humphrey, RBS and CSCA will act as co-managers. n

Zoll Medical (Chelmsford, Massachusetts) reported that the District Court of Munich, Germany, ruled in its favor in granting an injunction against Elan Med (Cologne, Germany) for infringing on a Zoll patent through the sale of certain Elan products for use with Zoll’s intravascular temperature management (IVTM) systems.

Elan has been ordered to stop making and selling the infringing products for use with Zoll’s IVTM systems (the Thermogard XP and CoolGard 300). The court also ruled that Zoll is entitled to recover damages resulting from sales of the infringing products that were incurred since Jan. 18, 2012 and ordered Elan to pay 90% of the court costs.

Zoll’s IVTM system is designed to provide cooling and warming through a balloon catheter inserted into the patient’s venous system. A startup kit is used to connect the Thermogard XP or CoolGard 300 temperature management console with a catheter to either warm or cool the saline as it flows through the catheter. This approach provides more accurate control of core body temperature than surface methods can, since it directly cools or warms the patient’s blood as it flows through the body. n

St. Jude Medical (St. Paul, Minnesota) reported the Japanese launch of its Ilumien OPTIS System, a technology designed to help physicians make personalized stenting decisions based on each patient’s unique anatomy and disease state. The Ilumien OPTIS system remains the only combined Fractional Flow Reserve (FFR) and intravascular Optical Coherence Tomography (OCT) imaging technology platform, the company said. Together, FFR and OCT offer physicians a physiological and anatomical view of the coronary vessels to help diagnose and treat coronary artery disease. The Ilumien OPTIS system provides enhancements to the Ilumien system, including a first-of-its-kind stent planning software tool.

The PressureWire Aeris Wireless FFR Measurement System collects detailed analyses of blood flow blockages in the coronary vessels to help determine which specific blockages are causing the patient’s blood flow to be ineffective. The FFR pressure guidewire is directed through the coronary arteries and across the narrowed vessel, taking measurements as the guidewire is pulled back through the narrowed part of the artery.

The OCT technology in the new Ilumien OPTIS system uses the Dragonfly JP Imaging Catheter to capture near-infrared light imaging and measure important vessel characteristics otherwise invisible or difficult to assess with older intracoronary imaging tools. New high resolution setting and real-time, three-dimensional (3-D) reconstruction with the Ilumien OPTIS provide a 360-degree panoramic view of the vessel, which makes it easier for physicians to visualize the anatomy they are treating.

Mazor gets Australian Renaissance order

Mazor Robotics (Caesarea, Israel) said LifeHealthcare, the company’s distribution and marketing partner in Australia, has ordered its first Renaissance system. The system will be used for training, marketing, and sales purposes, as the distributor’s sales force penetrates the Australian market. Mazor recently received regulatory approval in Australia.

“The system sold marks the first Renaissance to be installed in the region and will be used to demonstrate the value it can bring, helping to increase surgeon accuracy and improve patient outcomes. We look forward to introducing more systems to the Australian spinal surgery community as surgeons become accustomed with the technology and its benefits,” said Ori Hadomi, CEO of Mazor.

Renaissance is transforming spine surgery from freehand operations to highly-accurate, state-of-the-art procedures, with less radiation, the company said. n



ACCContinued from Page 1

leading up to ACC, the full data set, that is both safety and efficacy endpoints, were expected to be presented by the principal investigator, David Holmes, MD, Scripps professor of medicine at the Mayo Graduate School of Medicine (Rochester, Minnesota).

However, in an extremely unusual and perhaps unprecedented action, just a few days before the scheduled presentation, BSC reported that only the “acute procedural safety results” would be presented. No explanation was provided. A couple of days later, in another bizarre U-turn and possibly under pressure from the ACC, BSC reversed its position and said that the full results of the trial would end up being presented after all.

Finally, on Saturday morning, just hours before Holmes’ scheduled presentation, BSC put out a press release with the trial data, inadvertently violating the ACC’s strict rules about pre-release of clinical trial data. It appeared to be an innocent and unfortunate oversight, with the three-hour difference between the East Coast (where BSC is headquartered) and the West Coast (site of ACC meeting) likely causing the early release.

The week’s insanity was capped off by a terse statement from Beth Casteel, media relations director of the ACC, who said: “The embargo has been broken on the PREVAIL study. The embargo is immediately lifted and PREVAIL will not be presented in the late-breaking clinical trial session or the (ACC) press conference. The embargo was broken when Boston Scientific distributed the press release without embargo early this morning.” So, while the trial was not officially released, the full slide set was obtained by many in the media and the data was quickly disseminated worldwide.

The basic goal of PREVAIL was to alleviate lingering concerns about the safety and efficacy of the Watchman left atrial appendage (LAA) closure device left over from the earlier Embolic Protection in Patients with Atrial Fibrillation (PROTECT-AF) trial and the follow on continued access program. Data from PROTECT AF trial, which had been released at the ACC in 2009, showed encouraging efficacy results that met non-inferiority and showed a trend towards superiority of left atrial appendage closure over warfarin. However, safety was compromised by an excess of acute events, leaving the LAA arm with over 50% more safety events than the oral anti-coagulation drug therapy (warfarin) arm. Following a positive but lukewarm Circulatory System Devices Panel meeting also in 2009, the FDA in 2010 decided that another trial would be required to confirm the safety and efficacy of the Watchman.

There were three key endpoints to PREVAIL: (1) Acute (seven day) safety results, which included acute occurrence of death, ischemic stroke, systemic embolism and procedure or device related complications requiring major cardiovascular or endovascular intervention. This endpoint was met, based on a 2.2% event rate, whiich was

within the prespecified criterion for the endpoint: (2) The two other co-primary endpoints were efficacy endpoints which compared the Watchman arm to the control group (warfarin) at 18 months. Unfortunately, only 30 of 138 control patients and 58 of 269 device patients have been followed for 18 months.

The trial missed the second primary endpoint, the comparison between a composite of stroke, systemic embolism, and cardiovascular/unexplained death at 18 months. The 18-month rate was 6.4% in both groups. The third primary endpoint, which was a composite of ischemic stroke or systemic embolism occurring after day 7, was achieved. At 18 months the event rate was 2.53% in the device arm vs. 2.01% in the control arm, which met the prespecified criterion for non-inferiority.

In its ill-timed press release, BSC said that the trial showed that the “device continues to demonstrate positive clinical outcomes for patients with atrial fibrillation.”

Due to the embargo break, there was no formal presentation or press conference to discuss PREVAIL. However, in an impromptu meeting with a small cadre of reporters on Saturday afternoon, Holmes carefully explained the rationale for the trial design. In particular he discussed the use of a Bayesian adaptive trial design, which leveraged off of the PROTECT-AF trial data and reduced the number of patients needed to attain statistical significance.

Using a Bayesian design allowed the researchers to draw conclusions from the data, even though they had 18 month information from only 58 patients who received the device and 30 patients in the warfarin control group. There has been some debate in the cardiology community about whether this is a large enough cohort to draw accurate conclusions but this approach was apparently blessed by the FDA.

Holmes said that the safety data in PREVAIL was “giantly better” than and “twice as good” as PROTECT-AF. With that goal met and one of the two primary efficacy endpoints achieved, Holmes said that “it is a real step forward” and he voiced cautious optimism that the FDA will approve it.

In a research note after the PREVAIL travails, Lawrence Biegelsen, senior analyst, medical devices of Wells Fargo Securities (New York) opined that “we think the likelihood of Watchman approval has been lowered to about 50%-60% from 90%+ if all three PREVAIL endpoints had been met. Ultimately, we think FDA will require another advisory committee panel which could push approval out to 2014, best case scenario.”

In another interview with a few reporters, Gordon Tomaselli, MD, professor and director of the Division of Cardiology at the Johns Hopkins University School of Medicine (Baltimore) and immediate past president of the American Heart Association (Dallas) said that the safety data from PREVAIL makes him “less hesistant” to use the Watchman for a “select group of patients who have no other options.”

See ACC, Page 10



ECRContinued from Page 1

Massachusetts), further cemented its clinical lead with the publication in Radiology of results from the long-awaited, large-scale study showing, to no one’s surprise, that exposing women to a double shot of radiation in a screening exam results in the detection of more cancers. (MDD, Jan. 11, 2013)

The Oslo University trial compared conventional digital mammography with the same exam plus tomosynthesis, hamstrung by a clinical requirement to always use the established 2-D view mammograms in the massive screening setting screening technology in parallel with the proposed alternative of 3-D-like views rendered from multiple slices of tomosynthesis.

At this year’s European Congress of Radiology (ECR) Siemens reported preliminary findings on 9,000 patients from its own large-scale Malmö breast tomosynthesis screening trial that is bound by the same requirement.

GE is preparing to launch from Padua, Italy its own study targeting 20,000 women that would remove the training wheels from tomosynthesis and see how well it does going solo, head-to-head against standard mammograms, according to Christoph Harbereder, the company’s communication leader for Europe

Luca Giulio, senior mammography product manager for GE in Europe was less confident about exactly when GE would be able to upgrade the Senographe machine in Padua with the Essential tomosynthesis capability as the technology has not yet received CE mark approval, though he said he hoped it would be “soon.”

GE is also awaiting approval from the FDA.Regulatory approval would unlock a tremendous

opportunity for GE to offer this upgrade to an installed base of more than 2,400 Senographe Essential systems.

A slow follower in this emerging segment, GE will lead with an enhanced image quality thanks to a step-and-shoot technique for nine exposures in a 25-degree sweep that Giulio insists avoids a blurring found on competitors’ systems that use a continuous motion during the arc of the projector tube over the breast.

Radiation exposure is equivalent to a standard 2-D mammogram, he said.

The company literature suggests that once radiologists decide tomosynthesis can take the place of 2D mammograms, the cranial-caudal (CC) view will be eliminated so that the digital breast tomosynthesis mediolateral oblique view (MLO) would actually lower the dose compared to a standard mammogram.

High volume patient through-put is the last hurdle for tomosynthesis to win a place in screening.

The GE exam takes just 10 seconds, making it a contender.Yet radiologists who can read more than 60

mammograms per hour are slowed down by the very points that make tomosynthesis better able to detect cancers

earlier, which is multiple slices and greater detail.The manager for a high-volume radiology operation

based in Stockholm said that after a learning curve, radiologists are almost up to the needed speed with tomosynthesis at one exam per minute. (MDD, Feb. 22, 2013)

The tomosynthesis capability for Senographe Essential was eclipsed on the GE stand at ECR by the arrival of the U-Systems automated breast ultrasound for its European introduction.

In an aside an enthusiastic GE sales rep said the company sold 500 units during the Radiological Society Of North America’s (RSNA; Oakbrook, Illinois) meeting in Chicago, just weeks after acquiring the company. (MDD, Nov. 12, 2012).

When Philips purchased the mammographic business from Sectra (Linköping, Sweden) it acquired digital breast tomosynthesis prototypes but is more fascinated with the potential of the photon counting detector on the MicroDose unit for standard mammography.

At ECR 2013, the company actively promoted its upstream research with the unique spectral imaging potential and suggested it may make an end-run on tomosynthesis by building on MicroDose.

Giving radiologists more information in the standard, fast-read format they are accustomed to working with could prove a powerful differentiation in a very large market.

“Tomo is diagnostics, spectral imaging is screening with a lot of information that aids in follow-up diagnostics, said Philips Oliver Bornholdt, Global Market Development Manager.

“We are focused on screening and so we are asking what is the value-added of tomosynthesis in screening?” he said.

Dose is a concern in the screening setting where a woman returns every year in the U.S. and every two years in Europe over a 20- to 25-year period.

Through-put is a significant concern if compliance and participation goals of payers are to be met.

Overall, the intention is to lower the rate of false positives in the screening setting, Bornholdt said, adding that Philips is now accelerating the work in spectral imaging.

Once an enhanced spectral imaging platform is proven in clinical studies, he said, “We should be able to show some tomo-like benefits in screening by reducing the recall rate but at significantly lower dose.”

The MicroDose detector is called photon-counting because it is able to convert an X-ray photon into electric charge which can be measured.

There is a substantial reduction in wasted radiation energy as a result.

Studies continuously show MicroDose reduces exposure to radiation in a standard mammography exam from 18% to 50%

At sponsored symposium at ECR, Pietro Panizza, See ECR, Page 10



AbbottContinued from Page 1difference between Absorb and a metallic stent is that after the vessel has healed the Absorb device begins to gradually be reabsorbed into the body and it starts to breakdown after a year. It is fully absorbed over time. When its fully gone it leaves the vessel without any kind of metallic implant in the way that a DES metallic stent would leave a permanent metallic implant in the artery.”

Results from the ABSORB trial presented at ACC showed the rate of major adverse cardiovascular events (MACE) in 101 patients was 10% at three years, similar to a comparative set of data with a best-in-class drug-eluting stent at the same follow-up period. MACE is a combined endpoint that includes heart attack, death due to heart-related causes, or re-blockage of the blood vessel resulting in symptoms requiring the need for additional procedures at the original site of scaffold implantation.

In a subset of 45 patients, imaging techniques showed improvements in vasomotion (vessel movement) and a 7.2% increase in late lumen gain (an increase in the area within the blood vessel) from measurements taken at one and three years. These findings are unique to Absorb and are not typically observed with metallic stents that cage the vessel. There was also a decrease in plaque area inside the vessel between one and three years. Plaque is typically composed of fat, cholesterol, calcium and other deposits that accumulate in the wall of the artery in patients with CAD and can slow or stop blood flow to the heart.

“The three-year data reinforce that Absorb may provide unique benefits not possible with metallic stents, including increases in the average area within the blood vessel, reduction in plaque and improved vessel movement over time,” said Patrick Serruys, MD, PhD, professor of interventional cardiology at the Thoraxcentre, Erasmus University Hospital (Rotterdam, the Netherlands). “As the body of data and real-world experience increase for Absorb, we are seeing compelling evidence that a temporary scaffold that dissolves completely after doing its job represents the future of interventional cardiology treatment.”

The company has yet to receive FDA approval for the device, but it is approved in Europe and in about 40 countries outside of the U.S., Hamilton told MDD. He noted that the company submitting for FDA approval of Absorb was at least two years out.

“We just initiated a clinical trial in the U.S. called the ABSORB III trial and we announced that in January of this year,” he said. “That’s a trial of up to 2,250 patients across a number of sites in the U.S. We’re enrolling that trial. It’s a head to head comparison of the Absorb device vs. [the company’s] Xience metallic DES. We hope to have . . . data submitted to the FDA in 2015.”

In other ACC conference news; Edwards Lifesciences (Irvine, California) reported that preliminary results from The PARTNER II Trial demonstrated similar one-year

outcomes in mortality and major clinical events between the Edwards SAPIEN XT transcatheter aortic valve and the Edwards SAPIEN valve, yet fewer vascular events with the lower-profile SAPIEN XT valve during the late-breaking clinical trial at ACC.

The PARTNER II Trial enrolled 560 patients deemed inoperable for traditional open-heart surgery at 28 hospitals in the U.S. between April 2011 and February 2012. Patients were randomized to receive one of the two Edwards transcatheter aortic heart valves: 276 received the SAPIEN valve, and 284 received the SAPIEN XT valve.

Analysts called the data favorable and pointing specifically to mortality and stroke data saying that it was an improvement over PARTNER 1.

“As expected, mortality was similar between the two arms with a 30-day rate of 3.5% for Sapien XT and 5.1% for Sapien, and a 1-year rate of 22.5% for Sapien XT and 23.7% for Sapien,” Larry Biegelsen an analyst with Wells Fargo wrote. “Total strokes were also similar between the two arms with a 30-day rate of 4.3% and 4.1% for Sapien XT and Sapien, respectively, and a 1-year stroke rate of 5.9% and 5.7% for Sapien XT and Sapien, respectively. The combined 1-year rate death or major stroke in the PARTNER 2 study was 23.2% and 25.2% for Sapien XT and Sapien, respectively, which represents an improvement vs. a rate of 33% with Sapien in the PARTNER 1 study. We think the overall improvement in the rate of death and stroke between PARTNER 1 and PARTNER 2 is due to the lower-profile NovaFlex delivery system with less traumatic nose cone; better operator experience and movement further along the learning curve; and better patient selection.”

RBC Capital markets analysts said that FDA approval for the device could possibly happen by the end of the year.

“We expect Edwards to file the PARTNER II data in 2Q13, with FDA approval likely to occur as early as year-end,” Glenn Novarro an analyst with RBC wrote. “While the introduction of Sapien XT in the U.S. will allow physicians to treat patients opposed to transapical (thus increasing the market opportunity), the primary benefit of XT includes: faster procedure times; fewer complications; and shorter hospital stays. This should translate to hospitals making more money on a case.” n

Omar Ford; 404-262-5546;[email protected]

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WashingtonContinued from Page 1

Tier 1 PMA goals MDUFMA II

Fiscal year PMA/panel/PMR

Exped. PMA/panel

PMA modules

180 PMA supps

2008 64% 25% 54% 90%

2009 78% 50% 69% 85%

2010 79% 43% 78% 87%

2011 80% 14% 87% 96%

2012 100% 100% 70% 97%

Objective 60%/180 days 50%/180 days

75%/90 days

85%/180 days

House Ways and Means and the Energy and Commerce Committees. The previous version, the CT Colonography Screening for Colorectal Cancer Act of 2012, never made it past committee, however, and the current state of Medicare financing will present the move with substantial drag again this year. On the other hand, some private payers are covering the procedure, which puts the Centers for Medicare & Medicaid Services in a tough spot.

In a March 8 statement, Hall said “more than 50,000 Americans die each year from colon cancer, and one in every nineteen Americans will be diagnosed.” He remarked that the treatment costs associated with colorectal cancer is as high as $30 billion annually, arguing that virtual colonoscopy would “save billions of dollars in treatment [and] prevent unnecessary deaths.”

Gail Rodriguez, executive director of the Medical Imaging & Technology Alliance (MITA; Washington) said in a March 11 statement that the association sees CT colonography as a way to “increase compliance in patients who otherwise would avoid a diagnostic procedure that saves lives.” Rodriguez remarked that “several national studies” have demonstrated the value of the diagnostic service, adding that among the private payers who cover the procedure are UnitedHealthcare, Anthem BlueCross/BlueShield “and other private insurers.”

Medical Device Daily asked Brian Connell, director of government relations at MITA, whether the prospects

for this legislation are any better than previous years. He replied, “we have more evidence than ever about the utility and value for Medicare patients,” explaining that the bulk of the evidence in times gone by was for those aged 50 and up rather than using the age of Medicare eligibility as a starting point. This additional evidence, he said, “just begs Congress more than ever to focus attention.”

“I think there’s always a struggle for CBO to look past” the immediate costs, Connell said of the budgetary implications. He said the Congressional Budget Office “doesn’t ascribe a lot of savings to it,” although he asserted that such a policy should save the federal government some money over the long term.

When asked whether this kind of legislation is likely to gain more traction this time around, Connell replied, “the last year and a half, nobody has been pushing anything through Congress at all” because of major fiscal issues, thus choking off other considerations. He remarked, “I don’t think the recent history impacts the current prospects.”

Connell added that the accumulation of evidence for Medicare eligibles “means that [H.R. 991] should be able to move by itself” rather than needing to be packaged with other legislation, but he noted that such questions are often up to the leadership in the House and Senate.

MDD pointed out that coverage of CT colonography could be handled without a statutory mandate, and asked whether legislation is really necessary. “I think Congress is signaling to CMS that they should cover this,” he said, adding, “I think [administrators at CMS] still have a responsibility to provide beneficiaries with the best care possible” regardless of

whether Congress passes a law mandating coverage.

FDA says most MDUFMA II goals metFDA released a report on the second round of

medical device user fees in a report that claims a large measure of success. The report, signed by FDA commissioner Margaret Hamburg, MD, says that the Office of Device Evaluation “has already met or exceeded, or has the potential to meet or exceed . . . 23 of 27 tier 1 performance goals,” along with 20 of 27 tier 2 performance goals for 510(k)s and PMAs.

FDA noted that the number of PMAs, panel-track PMAs, and pre-market reports (PMRs) had peaked in 2010 at 53, which the agency noted was a five-year high. However, that number tailed off sharply two years later to 53, the same number as in 2008.

The report notes that not all the numbers are in for fiscal 2012, the last year under the Medical Device User Fee Agreement II (MDUFA II), and that hence some of the numbers for 2012 are projections based on the current rate of progress on any applications still outstanding from that period. n

Tier 1 and 2 goals for 510(k)s under MDUFMA II

Fiscal year 510(k) tier 1 510(k) tier 2 Total 510(k)s

MDUFAII 510(k)s

2008 94% 98% 3,901 3,309

2009 90% 98% 4,153 3,443

2010 91% 98% 3,935 3,189

2011 95% 99% 3,877 3,258

2012 97% 99% 4,044 3,831

Objective 90%/90 days 98%/150 days



“PREVAIL definitely allays some of my safety concerns,” he added.

Tomaselli estimated that about 5% of his patients with atrial fibrillation might be ideal candidates for the device, though he admiited that this pool may be shrinking with the FDA’s approval of three new oral anti-coagulation drugs in the past three years.

Accurately sizing the market potential for any new device or procedure is challenging but Biegelsen indicated that “we currently model U.S. Watchman sales of $38 million in 2014, increasing to $104 million in 2017, and worldwide Watchman sales of $29 million in 2013 and $159 million in 2017.”

David Lewis, another well-regarded medical device analyst from the investment banking firm Morgan Stanley (New York) said in a note before the ACC that he believes the market potential to be about $150 million. In addition,

ACCContinued from Page 6

Lewis noted that “. . . patient appetite for undergoing an interventional procedure to treat a condition already well controlled by drug therapy is likely to be limited.”

Meanwhile, Boston Scientific officials have estimated the potential market at $500 million within five years. Ken Stein, chief medical officer of the company’s cardiac rhythm management group said “we are really optimistic about this . . . we see it as fitting a huge patient need and having a huge amount of data to support it.”

Boston Scientific acquired the developer of the Watchman, Atritech (Plymouth, Minnesota) in January 2011 with an up-front cash payment of $100 million, with potential future milestone payments through 2015 worth up to an additional $275 million. These milestone payments were based on a combination of regulatory approvals (most likely PMA clearance) and the attainment of certain revenue levels. Atritech was founded in 2000 and had raised an estimated $100 million from the venture capital community prior to its purchase by BSC. n

MD, from the Università Vita Salute San Raffaele in Milan reported a 45% reduction in a study of 1,666 women women 40 to 49 years old.

In a side note, he said he found it funny that the eight women radiologists on his team waited for the arrival of the MicroDose unit before scheduling their own mammo exams.

The session was chaired by Mats Danielsson of the Royal Institute of Technology in Stockholm, who is also the founder of Sectra.

Sankar Suryanarayanan, Global Mammography Marketing Director at Philips Healthcare in Andover outlined the challenges that motivate the development of capabilities unique to the MicroDose platform.

First the sensitivity of mammography drops significantly with dense breast tissue while the risk of cancer for these women is four to six times greater.

He noted that in the group of younger women studied by Panizza the cancer detection rate was 8.2%, where with standard mammography it is 2% in this group.

A second issue is that interpretation of mammograms remains subjective with studies showing not only a wide variation between readers of the same images but even variations by the same reader returning to the same images at a different moment.

Philips is working to add to the MicroDose platform a capability for single-shot spectral imaging that would quantify breast density and generate maps for breast gladularity and thickness.

The results would be highly personal based on true data sets acquired from a woman’s exam with no modeling.

“It is the same exam with no additional views to read, no

ECRContinued from Page 7

additional radiation, and without contrast agents,” he said.The goal is a standardization with objective

quantification as well as a clear visualization of glandularity of density where with standard mammo it can not be distinguished.

The data can be integrated into DICOM headers and DICOM structured reports.

Another potential for spectral imaging on MicroDose is lesion characterization in the screening setting with a potential to distinguish cysts from tumors.

The upstream research for Philips is being conducted by Matthew Wallis, MD, at the Cambridge Breast Unit of the Cambridge University Hospitals in England.

After an animated but highly technical explanation of how measuring the attenuation of X-ray energy using the MicroDose platform he was able to successfully distinguished water from cysts and then a “reasonably good separation of spectral characteristics between cyst and tumor tissue.”

“We now have a stable method and the approval of the ethics committee to start a clinical study that will quite probably generate a ‘likelihood ratio’ for characterizing tumors in the screening setting,” he said.

This evidence, he said, would then support the start of a very large study to validate the ratios.

Meanwhile, Bornholdt said Philips continues to explore its options with tomosynthesis.

He also confirmed the company is working on an automated breast ultrasound scanner for the breast diagnostic setting.

“There is also more coming in other modalities,” he said cryptically.

A hint may have slipped during the symposium when Wallis was blunt in expressing his enthusiasm for computed tomography for the breast. n



People in the News

Product Briefs

• Amedica (Salt Lake City) has named Karl Farnsworth as chief financial officer. Farnsworth most recently was the senior VP and treasurer with Energy Solutions. Amedica is a spinal and reconstructive medical device maker.

• AtriCure (West Chester, Ohio) said Robert White has been named to the company’s board. White is currently president/CEO of Tyrx. AtriCure is a medical device company specializing in atrial fibrillation solutions.

• Civco (Coralville, Iowa) has named Hap Peterson as VP of North American sales for the radiation oncology business unit. Peterson most recently managed the sales team at Boston Scientific Neuromodulation. Civco’s Radiation Oncology division makes motion management solutions to improve patient outcomes and increase clinical productivity for head & neck, breast, lung, abdomen, prostate and other treatment sites.

• Laboratory Corporation of America Holdings (LabCorp; Burlington, North Carolina) said Adam Schechter, executive VP and president, global human health, Merck, has been named to its board, effective April 1. Schechter joined Merck in 1988 as a sales representative and has held a number of professional, managerial and executive roles in Merck’s global pharmaceuticals business. LabCorp makes diagnostic technologies.

• SurgiCount Medical (Irvine, California), the wholly owned operating subsidiary of Patient Safety Technologies, said Michael Roux has joined the company in the position of VP of product management. Roux previously wored at Hill-Rom where he was the global product director for the respiratory care franchise. Patient Safety Technologies, through its wholly-owned operating subsidiary SurgiCount Medical, makes the Safety-Sponge System, a solution clinically proven to improve patient safety and reduce healthcare costs by helping eliminate retained surgical sponges.

• AMSilk (Planegg, Germany) has produced what it calls the world’s first competitive man-made spider silk fiber, called Biosteel, which is made entirely from recombinant silk proteins. Biosteel has mechanical properties similar to that of natural spider silk when comparing toughness, a measure indicating the kinetic energy absorbed before the fiber breaks. The current fiber prototypes are smooth to the touch, pleasant to the skin and shine like silk. They are brilliant white and can be dyed with common techniques used in the textile industry. Applications for Biosteel may include high performance technical textiles, sporting goods, medical textiles and surgical products, such as meshes and other support textiles or wound coverings.

• Aspect Imaging (Toronto) reported the launch of its M2 3-D MR-based histology system for in vivo and ex vivo toxicological imaging. The M2 3-D MR-based histology system is a compact, high-performance MRI instrument for high-throughput in vivo and ex vivo imaging of pre-clinical samples. The M2 provides all of the benefits of MRI including high-resolution 3-D images of anatomical morphology and quantitative information of disease progression and regression. The M2’s design is based on an innovative permanent magnet design meaning that the magnet does not require costly cryogens to cool and maintain its magnetic field. It is also “self-shielded” and consequently there is virtually no external fringe magnetic field. As a result, the compact MRI can be placed in most locations in a research lab and it does not require any special infrastructure.

• invendo medical (New York) has entered the U.S. market by installing first systems at NYU Langone Medical Center and NewYork-Presbyterian Hospital/Columbia University Medical Center. According to the company, the invendoscope SC20 has several features that are new to the field of colonoscopy: it is a single-use colonoscope with a working channel; it is not pushed or pulled, but uses a computer-assisted (robotic) gentle drive technology; all endoscopic functions are performed using a handheld device and; it reduces forces on the colon wall.

• Toshiba (Tokyo) says it has developed an intelligent vital signs sensor module, Smart healthcare Intelligent Monitor Engine & Ecosystem; Silmee, that simultaneously senses information on key vital signs: Electric Cardio Gram, pulse, body temperature and movements, and that can deliver the data to smartphones and tablet PCs with wireless technology. The recently developed Silmee includes a Pseudo-SoC analog front end, a 32bit ARM processor chip and a dual mode Bluetooth bare chip in a 14.5 mm x 14.5 mm small package. By adding a few devices to the module, such as an antenna, battery and sensor heads, achieves a completely wearable vital signs sensor system. Among the chips included in the module, the flexible and compact

Pseudo-SoC analog front end is a very effective approach to implementing vital signs sensors, and extends recent rapid progress in vital sign sensor technologies.

• Vital 5 (Logan, Utah), a VentureMD portfolio company, has received FDA clearance for ReLeaf, a first-to-market, dual function catheter system that provides simultaneous anesthetic infusion and wound drainage. Continuous anesthetic infusion to the surgical site in the immediate post-operative period has been clinically proven to provide significant improvements to pain management, but this therapy is currently not compatible with the millions of surgical cases where a wound drain is prescribed. By offering an integrated system that provides effective continuous local anesthetic infusion while also providing an effective wound drain function, the Vital 5 ReLeaf will greatly expand the number of patients who can benefit from local anesthetic infusion therapy.

MDD’s Cardio ExtraTUESDAY, MARCH 12, 2013 PAGE 1 OF 2

A D D I T I O N A L D E V E L O P M E N T S I N O N E O F M E D - T E C H ’ S K E Y S E C T O R S

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Keeping you up to date on recent developments in cardiology

Molecular mechanism identified for response to cardiac stress . . . Myocardial hypertrophy, a thickening of the heart muscle, is an adaptation that occurs with increased stress on the heart, such as high blood pressure. As the heart muscle expands, it also requires greater blood flow to maintain access to oxygen and nutrients, necessitating an expansion of the cardiac vascu-lature. In a recent issue of the Journal of Clinical Investigation, Daniela Tirziu and researchers at Yale University (New Haven, Connecticut) identified a molecular mechanism by which the growth of new blood vessels (angiogenesis) and heart muscle growth are coordinated. Using a mouse model of myocar-dial hypertrophy, Tirziu and colleagues determined that nitric oxide triggers the destruction of a protein known as RGS4. Nitric oxide typically drives physiological changes associated with the relaxation of blood vessels, while RGS4 attenuates the activity of a cellular signaling pathway that promotes cardiac growth. The researchers say the findings reveal how increases in heart muscle and blood vessel growth are coor-dinated, linking changes in vasculature to changes in heart size.

Heart muscle scar tissue associated with increased risk of death among patients with cardiomyopathy . . . Detection of midwall fibrosis (the pres-ence of scar tissue in the middle of the heart muscle wall) via MRI among patients with nonischemic dilated cardiomyopathy (a condition affecting the heart muscle) was associated with an increased likeli-hood of death, according to a study appearing in the March 6 issue of JAMA. Nonischemic dilated cardio-myopathy is associated with significant illness and death due to progressive heart failure (HF) and sudden cardiac death (SCD). Despite therapeutic advances, five-year mortality remains as high as 20%. “Risk stratification of patients with nonischemic dilated cardiomyopathy is primarily based on left ventricular ejection fraction [LVEF; a measure of how well the left ventricle of the heart pumps with each contraction]. Superior prognostic factors may improve patient selection for implantable cardioverter-defibrillators (ICDs) and other management decisions,” according to background information in the article. Attention has recently focused on whether detection of myocardial replacement fibrosis (scarring of the heart muscle) may assist with risk stratification in dilated cardiomyopathy. Fibrosis is associated with contrac-tile impairment. Ankur Gulati, MD, of Royal Brompton Hospital (London), and colleagues evaluated whether midwall fibrosis (detected by late gadolinium enhancement cardiovascular magnetic resonance [LGE-CMR] imaging) predicts risk of death, independently of LVEF and other established prognostic factors in dilated cardiomyopathy. The study included 472 patients with dilated cardiomyopathy referred to a U.K. center for CMR imaging between November 2000 and December 2008 after presence and extent of mid-wall replacement fibrosis (scarring of the heart muscle present in the middle of the heart muscle wall) were determined. Patients were followed up through December 2011. During a median (midpoint) follow-up of 5.3 years, there were 73 deaths. Overall, 38 of 142 patients with midwall fibrosis (26.8%) died compared with 35 of 330 patients without midwall fibrosis (10.6%). After analysis, both the presence and percentage extent of midwall fibrosis were significant independent predictors of all-cause mortality. The arrhythmic composite end point (SCD or aborted SCD) occurred in 65 patients (14%). Analysis indicated that patients with midwall fibrosis were more than five times more likely to experience SCD or aborted SCD compared with patients without midwall fibrosis (29.6% vs. 7%). “After adjustment for LVEF and other conventional prognostic factors, both the presence of fibrosis and the extent were independently and incrementally associated with all-cause mortality. Fibrosis was also independently associated with cardiovascular mor-tality or cardiac transplantation, SCD or aborted SCD, and the HF composite [HF death, HF hospitalization, or cardiac transplantation],” the authors write. Also, the addition of fibrosis to LVEF significantly improved risk reclassification for all-cause mortality and the SCD composite. “Our findings suggest that detection and quantification of midwall fibrosis by LGE-CMR may represent useful markers for the risk stratification of death, ventricular arrhythmia, and HF for patients with dilated cardiomyopathy,” the researchers write.

TUESDAY, MARCH 12, 2013 MDD’S CARDIO EXTRA PAGE 2 OF 2

To subscribe, please call MEDICAL DEVICE DAILY™ Customer Service at (800) 477-6307; outside the U.S. and Canada, call (404) 262-5476.Copyright © 2013 AHC Media. Reproduction is strictly prohibited. Visit our web site at www.medicaldevicedaily.com.

Researchers examine thinning of myocardial wall in patients with CAD . . . Among patients with coronary artery disease referred for cardiovascular MRI and found to have regional myocardial wall thinning (of the heart muscle), limited scar burden was associated with improved contraction of the heart and reversal of wall thinning after revascularization, suggesting that myocardial thinning is potentially reversible, according to a study appearing in the March 6 issue of JAMA. Regional myocardial wall thinning is thought to represent chronic myocardial infarction. “However, recent case reports incorporating the use of delayed-enhancement cardiovascular magnetic resonance (CMR) imaging raise the possibility that this viewpoint is incorrect. These single-patient reports indicate that myocardial regions with severe wall thinning do not necessarily consist entirely of scar tissue but instead may have minimal or no scarring. Thus, some areas of myocardial thinning may represent viable myocar-dium and have the potential for recovery of function,” according to background information in the article. Dipan Shah, MD, of Duke University Medical Center (Durham, North Carolina) and colleagues con-ducted a study to evaluate patients with regional myocardial wall thinning and to determine scar burden and potential for functional improvement. The study, conducted from August 2000 through January 2008, included 1,055 patients with known coronary artery disease (CAD) who underwent CMR imaging. “Of 201 patients [19%] identified by CMR as having wall thinning, most had significant left ventricular dysfunction, multivessel CAD, and thinning of a substantial portion of the left ventricle. Among this cohort, 18% of thinned regions had limited or no scarring observed using delayed-enhancement CMR. Because the lack of scarring was associated with significant contractile improvement and reverse remodeling with resolu-tion of wall thinning following revascularization, we believe the data indicate that myocardial thinning is potentially reversible and therefore should not be considered a permanent state,” the authors write. “... we believe our study provides new insights into the pathophysiology of thinned myocardium and more broadly the process of reversible ischemic injury. The data show that thinned myocardium may consist of limited scar tissue and can recover function- concepts that are both inconsistent with current views. In an accompanying editorial, Deepak Gupta, MD, of Brigham and Women’s Hospital (Boston) and col-leagues write that the two cardiovascular imaging studies in this issue of JAMA “address the important issue of how supplemental noninvasive imaging studies can assist the cardiovascular specialist.”

Good cholesterol, or HDL, may possess anti-aneurysm forming properties . . . New research provides early evidence that ‘good’ cholesterol may possess anti-aneurysm forming properties. In laboratory-based investigations, scientists found that increased levels of high-density lipoproteins (HDL), the so-called good cholesterol, blocked the development of aneurysms - dangerous ‘ballooning’ in the wall of a blood vessel – in the body’s largest artery, the aorta. The research-ers say their findings – which are published in the American Heart Association (Dallas) scientific journal Atherosclerosis Thrombosis and Vascular Biology - lay the foundations for further investigations into ways of raising HDL cholesterol as a possible therapeutic intervention for the condition. The study, led by researchers from St George’s, University of London, found that elevating the amount of HDL cholesterol in the abdominal area of the aortic artery in mice both reduced the size of aneurysms that had already grown and prevented abdominal aortic aneurysms from forming at all. The researchers say that while more work is needed to understand the exact mechanism by which HDL cholesterol effects aneu-rysms, their investigations indicate that raising HDL cholesterol influences the activity of the aortic artery’s cells, which are the building blocks of its structure and function. They found that elevated levels of HDL had two key influences on the cells. Firstly, it altered the signals sent between cells, which, in turn, reduced the activity of a protein called ERK1/2 that is known for its cell growth properties. Secondly, it increased levels of HDL cholesterol induced programmed cell death, which is an essential part of the cell lifecycle that sees old cells replaced with new ones. The study focused on mice models of the area of the aorta just above the kidney (the suprarenal region) and the region that is just below the kidney and most commonly associated with aneurysm formation in humans (the infrarenal region). The researchers hope that the effects seen in these specific areas of the aortic artery will help explain basic mechanisms of aneurysm formation. The next phase of the investigations, which the researchers hope to begin this year, will see the researchers conduct laboratory tests with families of drugs that can elevate HDLs and repro-duce the observed effects on aneurysms.

— Compiled by Amanda Pedersen, MDD Senior Staff Writer [email protected]

medical device daily - march 12, 2013

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