you the quality of your patient care....prolapse repairs for over 15 years7. capio slim suture...

Women’s Health

CommitmentWe are committed to you...and advancing the quality of your patient care.

Product Innovation Boston Scientific is committed to developing new products, improving existing

product lines and exploring new, innovative ways to treat pelvic floor diseases

and related areas.

Clinical Excellence Boston Scientific is committed to supporting evidence-based medicine

through sponsoring and funding women’s health research worldwide

for the treatment of female stress urinary incontinence and

pelvic organ prolapse.

Professional Programs Boston Scientific is committed to helping you and your

patients advance knowledge around these disease states

and treatment options.

Boston Scientific remains committed to the women’s health space and is

Always There for both physicians and patients. We are anchored in our guiding

principle to provide innovative products that are supported with clinical data

and offer robust professional programs to advance the quality of care.

Our Commitment to You

PRODUCT INNOVATION

Stress Urinary IncontinenceAdvantage Fit™ and Advantage™ Transvaginal Mid-Urethral Sling Systems ............................ 2

Lynx™ Suprapubic Mid-Urethral Sling System ..................... 2

Obtryx™ II Mid-Urethral Sling System .................................. 4

Obtryx Mid-Urethral Sling System ....................................... 4

Solyx™ Single Incision Sling System .................................... 5

Coaptite™ Injectable Implant ................................................ 7

Pelvic Floor ReconstructionCapio™ SLIM Suture Capturing Device ................................ 8

TLC™ Retractor and Single-Step™ Pelvic Drape ................... 8

Repliform™ Tissue Regeneration Matrix, Xenform™ Soft Tissue Repair Matrix and Polyform™ Synthetic Mesh ......... 9

Uphold™ LITE Vaginal Support System with Capio SLIM Suture Capturing Device ........................ 10

UPsylon™ Y-Mesh and Colpassist™ Vaginal Positioning Device ................................................. 11

CLINICAL EXCELLENCE

Commitment to Clinical Research ..................................... 12

PROFESSIONAL PROGRAMS

EDUCARE, PFD Alliance and POP-Q System Program .................................................... 15

Boston Scientific Women’s Health Portfolio

Advantage SystemM0068502000 Advantage System (single unit) Each M006850200051 Advantage System Box 5Each System includes: One (1) Delivery Device and One (1) Mesh Assembly

Advantage Fit SystemOrder Number Description Unit

M0068502110 Advantage Fit System (single unit) EachM0068502111 Advantage Fit System Box 5Each System includes: One (1) Delivery Device and One (1) Mesh Assembly

The Lynx™ Suprapubic Mid-Urethral Sling System is designed to maneuver through challenging tissue with a smoother association mechanism in the suprapubic pathway.

Lynx SystemOrder Number Description Unit

M0068503000 Lynx System (single unit) EachM0068503001 Lynx System Box 5

Each System includes: Two (2) Delivery Devices and One (1) Mesh Assembly

The Advantage Fit™ & Advantage™ Transvaginal Mid-Urethral Sling Systems are retropubic offerings designed to create a new standard for sling placement. The Advantage Fit Transvaginal Mid-Urethral Sling System was designed with a 46% thinner needle and 17% tighter curve than the Advantage System to reduce insertion force and leave the mesh closer to the pubic bone, reducing potential chance of bowel or bladder injury.

Clinical Reference* In a retrospective review of 72 patients treated with the Advantage System at a mean follow-up of 16 months, 96% (69/72) objective cure rate was observed. Furthermore upon stratification, patients that had low urethral closure pressures (<20 of H20), and/or hypermobility still had an objective cure rate of 87% (13/15)1.

Clinical Reference* In a prospective study of 102 patients that were followed up at 1 year, 90% (92/102) were considered cured by subjective report and a negative standing stress test. There were 4 (3.4%) intra-op bladder perforations and 5 (4.2%) cases of erosion2.

Stress Urinary Incontinence

Advantage Fit

Designed for greater ergonomics, needle stability, and control during delivery.

Lynx System

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PRODUCT INNOVATION

The Advantage™ Mesh is a biocompatible knitted polypropylene material which has been heat treated and de-tanged in the sub-urethral portion of the sling. This heat sealed edge is designed to potentially reduce irritation to the anterior urethral wall. It is designed to reduce the risk of mesh deformation and maintain its integrity during tensioning. All Boston Scientific Mid-Urethral Sling Systems feature Advantage Mesh. The Advantage Mesh has been used in over 500,000 patients.

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The Obtryx Mid-Urethral Sling System is a transobturator design offering two needle configurations that allow physicians to choose the delivery method that meets their needs. This is for physician preference. The method of delivery is the same.

Obtryx System – Halo or CurvedOrder Number Description Unit

M0068504000 Obtryx System - Curved (single unit) EachM0068504001 Obtryx System - Curved Box 5M0068505000 Obtryx System - Halo (single unit) EachM0068505001 Obtryx System - Halo Box 5


The Obtryx™ II Mid-Urethral Sling System is a transobturator sling with enhanced features designed for smooth sling placement, intra-operative adjustability with minimal tissue disruption, and increased visualization for physicians to aid in precise sling placement.

Clinical Reference* In a prospective, randomized control trial, patients were treated with Obtryx System and Advantage™ System. The objective cure rate for the Obtryx System was 81% (68/84) and for the Advantage System 77% (67/87). Cure defined as less than 1 gram urine leak in standardized pad test. The subjective cure rate was 98.8% (85/86) for Obtryx System and 92.6% (88/95) for Advantage System. Pain at the time of the vaginal examine in the transobturator group was 15.5% in the transvaginal group was 5.6%3.

Obtryx II System – Halo or Curved

Order Number Description Unit

M0068504110 Obtryx II System - Curved (single unit) EachM0068504111 Obtryx II System - Curved Box 5M0068505110 Obtryx II System - Halo (single unit) EachM0068505111 Obtryx II System - Halo Box 5


Featuring PrecisionBlue™ Design

Obtryx II


Obtryx System

The Solyx™ Single Incision Sling System is designed to reduce dissection and associated risk, and to offer a procedure with fewer steps. The mesh carrier tip snap-fits to the delivery device allowing for advanced control and micro-adjustability during placement.

Clinical Reference* Long-term, multi-site retrospective results of 69 patients with mean follow up at 43 months showed that 93% of patients were dry and satisfied with their outcome on the basis of subjective assessment. Furthermore, there were no serious adverse events including no bladder, bowel, vessel or nerve perforations and no erosions or extrusions. No pain was reported that was attributed to the implant. There were 4 cases of denovo urge incontinence and 2 reports of transient retention4.

Solyx SIS SystemOrder Number Description Unit

M0068507000 Solyx SIS System (single unit) EachM0068507001 Solyx SIS System Box 5

Each System includes: One (1) Delivery Device and One (1) Mesh Assembly

SolyxSingle Incision Sling

Advanced Control with Micro-Adjustability

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PRODUCT INNOVATION

Our goal: More options for physicians and their patients


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Coaptite injection in the urethra

The Coaptite™ Injectable Implant is a bulking agent consisting of calcium hydroxylaptite [CaHA] particles in a carrier gel, designed for durability and effectiveness. The Coaptite Sidekick™ Needle is the complementary instrument that is designed to aid in the ease of injection.

Coaptite Injectable ImplantOrder Number Description Unit

M0068903000 1ml Syringe EachM0068903040 Sidekick Rigid Needle Each

CoaptiteClinical Reference* 63.4% of Coaptite Implant patients maintained a 1 or more Stamey Grade improvement at 12 months compared to 57% for patients treated with collagen in the PMA Clinical Study (p=0.3441)5. The Coaptite Implant patients required 41% less mean total material volume versus collagen patients during the PMA clinical trial6. After treatment, urge incontinence was reported in 5.7% of those receiving CaHA and 12% of those receiving collagen (P=0.05).Our goal:

More options for physicians and their patients

For effectiveness, durability and ease of use... it’s a natural.

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PRODUCT INNOVATION

Pelvic Floor Reconstruction

Order Number Description Size Closest Equivalent Unit

M0068331141 Non-absorbable, coated braided polyester, 0 TI-CRON Sutures / Box 12 double armed with TC tapercut needle (dart) and Ethibond Sutures a T 26mm 1/2 circle taper needle, 36”

M0068331131 Non-absorbable, coated braided polyester, 0 TI-CRON™ Sutures / Box 12 double armed with TC tapercut needle (dart), 48” Ethibond™ Sutures

M0068331241 Non-absorbable, polypropylene monofilament, 0 Surgilene Sutures / Box 12 double armed with TC tapercut needle (dart) and Prolene Sutures a T 26mm 1/2 circle taper needle, 36”

M0068331231 Non-absorbable, polypropylene monofilament, 0 Surgilene™ Sutures / Box 12 double armed with TC tapercut needle (dart), 48" Prolene™ Sutures

M0068332131 Absorbable, coated braided PGA, double 0 Dexon™ II Mesh / Box 12 armed with TC tapercut needle (dart), 48” Vicryl™ Mesh

M0068331371 Monodek™ Absorbable, monofilament PDO, 0 PDS™ Sutures Box 12 double armed with TC tapercut needle (dart) and a T 26mm 1/2 circle taper needle, 48"

Capio Sutures are available in various lengths with a tapercut needle in both absorbable and non-absorbable suture configurations.

36% Reduction in Head Width

Capio SLIM Suture Capturing

Device

Capio OPEN ACCESS Suture Capturing

Device

Over 400,000 Capio Devices have been utilized to date, facilitating vaginal prolapse repairs for over 15 years7.

Capio SLIM Suture Capturing Device

Order Number Description Unit

M0068318250 Capio SLIM Suture Capturing Device Box 1M0068318261 Capio SLIM Suture Capturing Device Box 5

Capio SLIM

The Capio™ SLIM Suture Capturing Device is designed to enable an intra-vaginal, trocar-free, minimally invasive prolapse repair. The Capio Device is designed for use with the Uphold™ LITE System and custom graft repairs. The Capio SLIM Device features a reduced head width and shaft diameter to minimize the space occupied within the surgical field, easy suture loading and a funnel shaped catch, designed for consistent ease of use.


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The TLC™ Retractor offers self-retaining soft tissue retraction for enhanced surgical access. The elastic stays and finger grip hooks are designed for a secure fit in the ring notches to diminish slippage and increased control.

Pelvic Floor AccessoriesOrder Number Description Unit

M0068201750 TLC Retractor with 6 Stay Hooks EachM0068201761 TLC Retractor Box 5M0068201781 TLC Retractor Stay Hooks Box 2M0068201060 Single-Step Pelvic Drape Each

Xenform Soft Tissue Repair Matrix

Order Number Size (cm) Unit

M0068302410 2 x 7 EachM0068302430 4 x 7 EachM0068302450 6 x 10 EachM0068302470 8 x 12 Each

Polyform Synthetic Mesh (abdominal approach)Order Number Size (cm) Unit

M0068402580 10 x 15 EachM0068402581 10 x 15 Box 5M0068402590 15 x 20 Each

Repliform Tissue Regeneration Matrix Order Number Size (cm) Unit

M0068202400 2 x 4 EachM0068202410 2 x 7 EachM0068202420 3 x 7 EachM0068202430 4 x 7 EachM0068202440 2 x 12 EachM0068202450 5 x 10 EachM0068202460 6 x 12 Each

The Single-Step™ Pelvic Drape features durable fabric designed for rigorous, high-fluid procedures, reducing the potential need for costly drape layering.

Capio Sutures are available in various lengths with a tapercut needle in both absorbable and non-absorbable suture configurations.

The Repliform™ Tissue Regeneration Matrix is a human dermis allograft while Xenform™ Soft Tissue Repair Matrix is a bovine dermis xenograft. Along with Polyform™ Synthetic Mesh, these products offer various material choices for a customized pelvic organ prolapse repair.

Repliform Matrix

Xenform Matrix

Over 400,000 Capio Devices have been utilized to date, facilitating vaginal prolapse repairs for over 15 years7.

Customizable... based on Patient Needs

TLC Retractor

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PRODUCT INNOVATION

Clinical Reference* A prospective study of 72 anterior colporrhaphies with a cellular dermal implant (Repliform Matrix) compared to 61 standard anterior colporrahaphies, with a 9 month or greater follow up where 19% (14/72) recurrences were identified in the dermal graft group vs. 43% (26/61) in the colporrhaphy group (p=0.004). The dermal graft group had higher rates of urge incontinence compared to the colporraphy group. No vaginal erosions were observed in either group8.

Uphold LITE System in Final Placement with Uterus Present

Uphold LITE System in Final Placement without the Uterus Present

The Uphold™ LITE Vaginal Support System with Capio™ Slim Suture Capturing Device is a small footprint mesh intra-vaginal anterior & apical prolapse system designed to avoid mesh overlapping the incision line, and facilitating mesh placement where it is desired.

Clinical Reference* In a retrospective cohort study of the first 115 consecutive patients treated with the Uphold System with a median follow-up of 12.1 months, anterior recurrence was observed in one patient (0.8%) when defined as Ba > 0. Apical recurrence was observed in 2 patients (1.7%) when defined as C>0. The rate for mesh exposure was 3/115 (2.6%). High rates of satisfaction and improved condition-specific QOL were observed9.

Uphold LITE Vaginal Support System Order Number Description Unit

M0068318170 Uphold LITE Vaginal Support System Each with Capio Slim Suture Capturing Device

System includes: One (1) Capio™ SLIM Device and One (1) Mesh Assembly

It’s more than light-weight mesh, it’s Low Surface Area and a Reduced Profile delivery device.

Uphold LITE System


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UPsylon Y-Mesh

The UPsylon™ Y-Mesh features lightweight, low surface area technology to minimize mesh contact with the vaginal wall. The mesh handling characteristics, large pores and blue color are designed to ease positioning and fixation to assist with placement.

The Colpassist™ Vaginal Positioning Device is the first device specifically designed for vaginal positioning in gynecologic procedures and as a suturing platform for vaginal wall fixation during sacrocolpopexy.

UPsylon Y-Mesh Order Number Description Unit

M0068318200 UPsylon Y-Mesh EachM0068318210 Colpassist Vaginal Positioning Device EachM0068318220 UPsylon Y-Mesh Kit Each

It’s more than light-weight mesh, It’s ease of positioning and fixation.

Colpassist Vaginal Positioning Device

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PRODUCT INNOVATION


Boston Scientific is committed to providing clinical data to support our key products. This sample list reflects some of the clinical research we are supporting through our Investigator Sponsored Research program and internal sponsored trials as we partner with the physician community to achieve clinical excellence.

Lead Investigator Study Objective Primary Endpoint Target Completion

Peter Sand, MD Retrospectively compare post-operative pain scores for suture-based sacrospinous fixation vs. Uphold LITE System for treatment of POP

Post-operative pain scores 2016

Daniel Altman, MD, Christian Falconer, MD

Prospectively assess objective and subjective outcomes of Uphold LITE System (Anterior/ Apical) for treatment of POP

POP-Q Stage < 1, no bulge 2016

Robert Gutman, MD1 Prospectively compare anatomic and symptomatic outcomes of Uphold LITE System (Anterior/ Apical) vs. Laparoscopic Sacral Hysteropexy for treatment of POP

POP-Q score at 12 months, no bulge symptoms, no retreatment for POP

2016

Renaud de Tayrac, MD2 Prospectively assess anatomic/ symptomatic outcomes of Uphold LITE System (Anterior/ Apical) for treatment of POP

POP-Q score at 12 months, no bulge symptoms, no retreatment of POP

2017

Joseph Lee, MD Prospectively compare anatomic/symptomatic outcomes of Uphold LITE System (Anterior/ Apical) vs. Vaginal Hysterectomy for treatment of POP

POP-Q scores at 12 months 2017

Karen Noblett, MD3 Prospectively assess objective and subjective outcomes of Uphold LITE System (Anterior/ Apical) for treatment of POP

POP leading edge at/beyond hymen, bulge with bother, retreatment for failed POP repair

2019

Charles Nager, MD4

PFDN/NICHDProspectively compare objective and subjective outcomes of Uphold LITE System (Anterior/ Apical) to Hysterectomy with Uterosacral Ligament Suspension for treatment of POP


2018

Peter Rosenblatt, MD5 Prospectively assess objective and subjective outcomes of Xenform Soft Tissue Matrix for treatment of POP


2018

Nathan Guerette, MD Prospectively compare UPsylon Y-Mesh and Restorelle™ Y Mesh in the performance of RASC and assess intra- operative characteristics and outcomes

Operative data, anatomy, safety, QoL

2017

Catherine Matthews Compare vaginal mesh or suture exposure rates in women undergoing robotic total hysterectomy and sacrocolpopexy with UPsylon Y-Mesh using permanent vs delayed absorbable sutures

Anatomic, subjective evaluations, additional surgical procedures for recurrent anterior or apical repair, feeling of bulge, QoL questionnaires, complications

2017

Catherine Matthews Evaluate the impact of Colpassist on individual procedure steps during RASCP and to assess surgeon satisfaction

Procedural time, surgeon satisfaction, impact on operative cost

2016

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Commitment To Clinical Research


Lead Investigator Study Objective Primary Endpoint Target Completion

N/A Assess long-term safety & effectiveness of Coaptite Injectable Implant and re-treatment rates

Long-term safety & effectiveness, time and impact of re-treatment

2015

Amanda White, MD Joseph Schaffer, MD6

Prospectively compare objective and subjective outcomes of Solyx SIS System to Obtryx II System for treatment of SUI

Negative cough stress test and patient improvement (PGI-I)

2017

Jonathan Duckett, MD Assess long-term data on the safety and efficacy of Advantage sling

SUI status on King’s Quality of Life Questionnaire, rates of re-operative, rate of mesh removal for erosion

2016

Pierre Costa, MD Long-term follow-up of transvaginal Retropubic and mid-urethral sling for SUI in an historic cohort of women

Efficacy of SUI, post-operative complications, re-operation rates, pain

2016

Erin Brennand, MD Evaluate two standardized techniques of Retropubic sling tensioning

Abnormal post-operative bladder function, rates of discharge with catheterization, QoL, adverse events

2017

* The following trials have been registered at www.clinicaltrials.gov: 1 NCT01377142, 2 NCT01559168, 3 NCT01917968, 4 NCT01802281, 5 NCT01945580, 6 NCT01784588

Results from case studies are not predictive of results in other cases. Results in other cases may vary.

Committed to clinical excellence

CLINICAL EXCELLENCE

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Our goal: Design Innovative Solutions

Professional Programs

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Boston Scientific is a founding member of the Pelvic Floor Disorders (PFD) Alliance, along with the American Urogynecologic Society (AUGS), the Foundation for Female Health Awareness and several global pharmaceutical companies. All Alliance members are working from a shared vision to improve the quality of life for women through patient education and access to a comprehensive list of treatment options.

Visit www.voicesforpfd.org/breakfree to learn how you can host your own patient outreach event and raise awareness.

The Interactive Pelvic Organ Prolapse Quantification (POP-Q) System Program is designed to increase your efficiency and enhance your effectiveness during patient consults. The program minimizes the need to sketch images by hand and it complements your knowledge with interactive disease state animations. It is available on the PFI website as well as an app via iTunes™.

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EDUCARE is a comprehensive suite of education and training programs that support healthcare professionals in the delivery of patient care worldwide. We offer a variety of programs including preceptorships, proctorships, lectures and cadaver labs to support the safe and effective use of our products in the treatment of pelvic organ prolapse and stress urinary incontinence. The programs were developed in partnership with thought-leading faculty with a goal to enhance surgical techniques and knowledge to ultimately improve the quality of patient care.

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References

1 Julia J, et al. Long-Term Experience in 72 Patients Treated with the Advantage™ Sling System.

Boston Scientific paper 2005.

2 Lynx™ Midurethral Sling System: a 1-year prospective study on efficacy and safety. Int Urogynecol J.

2008; 19: 1217-1221.

3 Ross S, Magali R, et al. Transobturator Tape Compared with Tension-Free Vaginal Tape for Stress

Incontinence, A Randomized Controlled Trial, Obstetrics & Gynecology, 114 (6), Dec 2009, 1287-93.

4 Serels S, et al. Long Term Follow up of the Solyx™ Single Incision Sling in the Treatment of Female

Stress Urinary Incontinence (SUI), Open Journal of Urology, 2014, 4, 13-17.

5 PMA Clinical Trial: Coaptite™ patients (n = 83) out of a total of 131 patients who had 12 month follow up.

Collagen patients (n = 57) out of a total of 100 who had 12 month follow up.

6 PMA Clinical Trial: Coaptite Implant patients (n = 131) received a mean total volume of 4.0 mls versus

6.8 mls for the Collagen patients (n = 100). P< 0.0001.

7 Capio™ Suture Capturing Device initially commercialized in 1994. Data on file.

8 Botros SM, et al. Arcus-anchored acellular dermal graft compared to anterior colporrhaphy for stage II

cystoceles and beyond. Int Urogynecol J. 20 (10) 2007.

9 Vu M, et al. Minimal mesh repair for apical and anterior prolapse: initial anatomical and subjective

outcomes. Int Urogynecol J. Published online 25 April 2012.

*Refer to the article/reference for a complete review of all results

References

Please refer to the Product Catalog for ordering information.

You may also contact your local Boston Scientific Representative,

or call Customer Service at 1-888-272-1001.

To learn more, visitwww.pelvic-floor-institute.com

For Advantage, Advantage Fit, Lynx, Obtryx, Obtryx II and Solyx: CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician trained in use of surgical mesh for repair of stress urinary incontinence.

For Coaptite Injectable Implant: INDICATIONS: Coaptite Injectable Implant is indicated for soft tissue augmentation in the treatment of stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (lSD) in adult females. CONTRAINDICATIONS: The Coaptite Injectable Implant is contraindicated for use in a patient: who has significant history of urinary tract infections without resolution; who has current or acute conditions of cystitis or urethritis; who has fragile urethral mucosal lining. POTENTIAL ADVERSE EFFECTS that may occur include: genitourinary adverse events (i.e., urinary retention, hematuria, dysuria, UTI, urinary urgency and frequency), erosion, erythema, embolic phenomena, and vascular occlusion. WARNINGS: Note: Failure to follow any instructions or to heed any Warnings or Precautions could result in serious patient injury. WARNING: Following injection of Coaptite Implant, dissection of the device through tissue may lead to 1) tissue erosion and may require corrective surgery or 2) elevation of the bladder wall causing ureteral obstruction. This may be caused by improper injection technique using Coaptite Implant. (See adverse event section in IFU for further information.) WARNING: Women with peripheral vascular disease and prior pelvic surgery may be at increased risk for tissue erosion following injection of Coaptite Implant. (See adverse event section in IFU for further information.) Please refer to complete instructions for use for a complete listing of all warnings and potential adverse effects. CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician trained in diagnostic and therapeutic cystoscopy.

Repliform Tissue Regeneration Matrix complies with U.S. Regulations in 21 CFR part 1271 Human Tissue Intended for Transplantation.

For Xenform Matrix: CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician trained in use of surgical mesh for repair of pelvic organ prolapse.

For Uphold LITE Vaginal Support System: CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician trained in use of surgical mesh for transvaginal repair of pelvic organ prolapse.

For Upsylon Y Mesh: CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician trained in performing mesh procedures for surgical repair of pelvic organ prolapse.

Accordingly for medical devices: CAUTION: Federal Law (USA) restricts these devices to sale by or on the order of a physician.

Please refer to package insert provided with these products for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events, and Instructions prior to using these products.

Results from case studies are not predictive of results in other cases. Results in other cases may vary.

All trademarks are property of their respective owners.

For more information:www.pelvic-floor-institute.com

Boston Scientific Corporation300 Boston Scientific Way Marlborough, MA 01752www.bostonscientific.com/gynecology

Ordering Information 1.888.272.1001

© 2016 Boston Scientific Corporation or its affiliates. All rights reserved.

WH-247607-AB JAN/2016

you the quality of your patient care....prolapse repairs for over 15 years7. capio slim suture...

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