CMS IDE Clinical Trials Biomaterials BEMA 2 27 2017

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

[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

[email protected]

mailto:[email protected]

http://www.linkedin.com/pub/mike-helmus/1/3a8/9b7

http://scholar.google.com/citations?user=fX7mQJMAAAAJ

http://phdtree.org/scholar/helmus-michael-nevin/


Technologies Driving Medtech Sustainability

Ideation Commercialization


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


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

https://www.cms.gov/Medicare/Coverage/IDE/index.html


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


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.


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


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


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


Comparison to Approved PMA’s

Granta Design prepared Biomaterials List in these PMAs60 most recent approvals


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


Biological PEG-HAS (albumin) hydrogel adhesionBovine Pericardium for TAVRPorcine Pericardium for TAVRBSA surgical sealant


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


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


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


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


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

CMS IDE Clinical Trials Biomaterials BEMA 2 27 2017

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