cms ide clinical trials biomaterials bema 2 27 2017
TRANSCRIPT
Michael N. Helmus, Ph.D., Consultant(508) 767 0585 [email protected]
February 27, 2017
Biomaterials in CMS/IDE Clinical Trials
new markets new products
new expectations
Michael N. Helmus, Ph.D., Consultant BEMAMedical Devices, Biomaterials, Drug Delivery, and Nanotechnology(508) 269 6021
Acknowledgments: Sarah Egan, Granta Design for data from recent PMA approvals
Michael N. Helmus, Ph.D., Consultant(508) 767 0585 [email protected]
•Emergent Disruptive Technologies• Medicare Coverage Related to Investigational Device
Exemption (IDE) Studies• CMS/Clinical trials - Biomaterials • Comparison to Approved PMA’s• IDE/PMA Approvals – Biomaterials•Medical Materials Database
Agenda
Michael N. Helmus, Ph.D., Consultant -Medical Devices, Drug Delivery, NanoTechnology, Tissue Engineering(508) 269 6021 fax (508) 519 6140 [email protected]
http://www.linkedin.com/pub/mike-helmus/1/3a8/9b7 http://scholar.google.com/citations?user=fX7mQJMAAAAJhttp://phdtree.org/scholar/helmus-michael-nevin/
AcknowledgementsDr. Sarah Egan, Granta DesignMedical Devices Product Manager
Michael N. Helmus, Ph.D., Consultant(508) 767 0585 [email protected]
Technologies Driving Medtech Sustainability
Ideation Commercialization
Michael N. Helmus, Ph.D., Consultant(508) 767 0585 [email protected]
Clinical Centers
Investors/ROI
Physician Collaborators IP Strategy
Disruptions outside Medtech
Competit ion
Resource Limits
M&A and Downsizing
Regulatory Strategy
Commercial Lifetime
Technical Challenge: Design Intent
Bundled Insurance Reimbursement
Drain on Innovation
Michael N. Helmus, Ph.D., Consultant(508) 767 0585 [email protected]
Medicare Coverage Related to Investigational Device Exemption (IDE) Studieshttps://www.cms.gov/Medicare/Coverage/IDE/
https://www.cms.gov/Medicare/Coverage/IDE/Approved-IDE-Studies.html
Michael N. Helmus, Ph.D., Consultant(508) 767 0585 [email protected]
Michael N. Helmus, Ph.D., Consultant(508) 767 0585 [email protected]
Michael N. Helmus, Ph.D., Consultant(508) 767 0585 [email protected]
Biomaterials Identification
Biomaterials are not identified in CMS data
-Utilized Trade Name and company URL
-Published literature on device
-Patents - using assignee name author names as inventors
-FDA.Gov for related devices from company
Michael N. Helmus, Ph.D., Consultant(508) 767 0585 [email protected]
Medicare Coverage Related to Investigational Device Exemption (IDE) Studies
https://www.cms.gov/Medicare/Coverage/IDE/index.htmlhttps://www.cms.gov/Medicare/Coverage/IDE/Approved-IDE-Studies.html
Study Title Sponsor Name
NCT Number
IDE NumberCMS Approval Date
Category Category Device
Tack Optimized Balloon Angioplasty Study for the Below
The Knee Arteries Using the Tack Endovascular System®
Intact Vascular
NCT02942966
G160144 12/5/2016 B Interventional Implantation of a Tack (metallic stent) using the Intact Vascular Tack Endovascular System for the repair of post angioplasty dissections below the knee.
Safety and Efficacy of Adult Adipose-Derived Stem Cell
Injections Into Partial Thickness Rotator Cuff Tears
InGeneron, Inc.
NCT02918136
BB16956 12/5/2016 B Regenerative Medicine
The Transpose® RT System consists of the Transpose® RT Tissue Processing Unit plus a number of other disposable components, including the
pharmaceutical-grade Matrase™ enzyme blend and single use disposables that
enable the isolation of regenerative cells from a
patient’s own adipose tissue.
Michael N. Helmus, Ph.D., Consultant(508) 767 0585 [email protected]
Biomaterials Combination Device Primary Outcome
Minimized metallic content NA Freedom from major adverse limb events (MALE) at 12 months defined as above-ankle target limb amputation or major re-intervention to the target lesion(s) (i.e. new
bypass graft, jump/interposition graft revision, or thrombectomy / thrombolysis)
The system is traditional collection systems and processes using adipose
derived stem cell injection. Uses Transpose® RT Tissue Processing
Unit for point-of-care rapid isolation of regenerative cells: an automated and preprogrammed processing device for
the heating, agitation, and centrifugation of adipose-derived
tissue.
Device: Adipose-derived stem cell injection; Drug:
cortisone injection
safety evaluation as indicated by collection of adverse events
Michael N. Helmus, Ph.D., Consultant(508) 767 0585 [email protected]
CMS/Clinical trials - Biomaterials Previous 60 listings
Polymers Acrylic/Gelatin embolic microspheres Polyurethane prepoymer for anastomotic surgical sealantPolyurethane insulator materialsPLGA part of vascular closure device
ePTFE suture, which have a labeled indication for use as artificial chordae tendinae.Pleural catheter: Silicone, Barium Sulfate, Polyester, Polyisoprene, Polypropylene, Colorant, ABSBreast Implant: Dimethyl Silicone Elastomer Dispersion, Diphenyl Silicone Elastomer Dispersion, MED 4750 Silicone, Silicone Gel
Biological gelatin anastomoic seal (GI)Collagen foam – Vascular closure devicepericardial tissue (percutaneous heart valves)Porcine SIS (Small intestinal submucosa) percutaneous heart valvesCollagen based hemostats for abdominal and orthopedic surgery
Emergent biomaterialsInteresting biomaterials
Michael N. Helmus, Ph.D., Consultant(508) 767 0585 [email protected]
Metals – (Stents with strong focus on Peripheral Disease, Meshes) Electrode materials (not described)Plantinum–iridium wires cochlear implant electrode wiresNitinol filaments and Nitinol monofilament wire with a radiopaque platinum core.
silicone covering
Metallic Radioactive Isotopes Yittrium 90
Combination Metallic Radioactive Isotopes Yittrium 90 followed by ipilmumab & nivolumabDrug Coated BalloonDrug, Radiation, Biologic (stem cell)Silver Nitrate coated catheter for Pleura applications
Michael N. Helmus, Ph.D., Consultant(508) 767 0585 [email protected]
Comparison to Approved PMA’s
Granta Design prepared Biomaterials List in these PMAs60 most recent approvals
Michael N. Helmus, Ph.D., Consultant(508) 767 0585 [email protected]
IDE/PMA Approvals – Biomaterials60 most recent approvals
PolymersPLA stents PVA implant for treatment of first metatarsophalangeal joint osteoarthritisFluoropolymer (ETFE, PTFE) pacer lead componentsePTFE for stent graftPolyester fabric for stent graft; TAVR Stent components; tissue ingrowth component
pacer lead Polypropylene suture for holding graft components to stent for stent graft & TAVRSilicone Rubber insulationPEBA (polyether block amide) components: ablation systems; Stent graft componentPLGA coating for drug release DES everolimusPolyimide pacer lead componentPoly(ethylene), Ultra-High Molecular Weight (UHMWPE) for cervical disk prosthesisPolycarbonate component Annuloplasty deviceBiolinx: proprietary components C10 and C19, and PVP (polyvinyl pyrrolidone) Parylene C stent coating Poly n-butyl Methacrylate (PBMA) stent coating Poly(vinylidene Fluoride-co-Hexafluoropropylene) (PVDF-HFP) stent coating
Emergent biomaterials Interesting biomaterials
Michael N. Helmus, Ph.D., Consultant(508) 767 0585 [email protected]
Biological PEG-HAS (albumin) hydrogel adhesionBovine Pericardium for TAVRPorcine Pericardium for TAVRBSA surgical sealant
Michael N. Helmus, Ph.D., Consultant(508) 767 0585 [email protected]
Metals NiTi: Stents; TAVR stents; Stent graft; Pacer lead componentPt markers on PLA stent; Abdominal Aortic StentPt-Ir stent graft; over-brazed with 24K Au for stent graft Pt-Ir: irrigated ablation system; neurostimulator; pacer leadPlatinum black coating on Pt-Ir pacer electrode302 SS irrigated ablation system316 L connector in pacer lead componentsPt-Cr (Fe-33Pt-18Cr-9Ni-3Mo) stent; stent for DESMP35N frame TAVR; Pacer leadsCP Ti anode electrode in pacer device; bone contacting coating cervical diskTi 6 4 cervical disk, spinal diskTa radiopaque markers stent graftCo-28Cr-6Mo Stent for TAVR; cervical disk prosthesisCo-20Cr-16Fe-15Ni-7Mo Egiloy alloy for annuloplasty MitraClip; coronary stentCo-20Cr-15W-10Ni peripheral stentCo-35Ni-20Cr-10MoFe-33Pt-18Cr-9Ni-3Mo stent coatingFe-17Cr-14Ni-2.5Mo TAVR Stent
Michael N. Helmus, Ph.D., Consultant(508) 767 0585 [email protected]
Carbon & CeramicsTi carbide bearning surface cervical diskPyrolytic carbon coated suture and components TAVR Hydroxyapatite (per ISO 13779) plasma spray coating cervical disk prosthesis Dicalcium Phosphate Dehydrate (DCPD) Coating cervical Disk
CoatingsHeparin, Polyethyleneimine/Endpoint Attached Coating on ePTFE Stent graftPyrolytic carbon coated suture and components TAVRHydroxyapatite (per ISO 13779) plasma spray coating cervical disk prosthesis Dicalcium Phosphate Dehydrate (DCPD) Coating cervical DiskBiolinx: proprietary components C10 and C19, and PVP (polyvinyl pyrrolidone)
stent coatingParylene C stent coating
Combination Steroid releasing Silicone pacer leadDES everolimusDCB paclitaxel with sorbital and polysorbateDES PaclitaxelDES Zotarolimus-Eluting
Michael N. Helmus, Ph.D., Consultant(508) 767 0585 [email protected]
Generic Biomaterials Observations
- Very little biomaterials innovation seen in these CMS/IDE and PMA Studies
Would expect the following to move into trials and approvals:
- Miniaturized sensors for feedback and active control of implant (bioelectric, drug delivery…)
- Regenerative medicine will be driving new scaffold designs based on traditional biomaterials
- Porosity- Control of surface chemistry- Control of nano/micro texture- Bioactive coatings
Michael N. Helmus, Ph.D., Consultant(508) 767 0585 [email protected]
Materials for FDA-approved implantable devices
ASM International/Granta
M. N. Helmus, Ph.D.Chair Medical Materials Database Committee
http://mio.asminternational.org/mmd/
New Tools for Medical Device Design
Michael N. Helmus, Ph.D., Consultant(508) 767 0585 [email protected]
Michael N. Helmus, Ph.D., Consultant(508) 767 0585 [email protected]
Michael N. Helmus, Ph.D., Consultant(508) 767 0585 [email protected]
Michael N. Helmus, Ph.D., Consultant(508) 767 0585 [email protected]
Commercializing New Technology: Development Cycle
Start
Preclinical /Clinical
Animal testing IDE/IND
Human Clinical
CMS/Reimbursement
Concept
Prototype
Quality Systems Packaging CMC Chemistry Manufact. Controls Sterility
InventoryMarketing
Epidemiology, AdverseReporting, Post-MarketSurveillance
Toxicology, Hazard Analysis, Study Design, StatisticsToxicokineticsPharmacology,Pharmacokinetics,ADME, Biocompatibility
FMEADesign Freeze
National
MaterialsComponentsTechnology Pharma Biologics
Modified from Helmus, Nature Nanotechnology 1, 157 - 158 (2006)
510K, PMA,NDA, CMS Approval