The Nexeon Bistable Nitinol Stent Family William A

The Nexeon Bistable Nitinol Stent Family William A. Gray MD Director of Endovascular Services Associate Professor of Clinical Medicine Columbia University Medical Center The Cardiovascular Research Foundation

DISCLOSURES William A. Gray, MD Consulting Fees – Access. Closure, Inc. , Co. Aptus, Inc. , Mercator Med. Systems, Inc. , Ovalis, Inc. , Paragon Medical, Inc. , Pathway Medical Technologies, Inc. , Sage Medical, Inc. Grants/Contracted Research – Atritech, Inc. , Cordis, a Johnson & Johnson company, CREST/ National Institutes of Health, W. L. Gore & Associates, Inc. Ownership Interest (Stocks, Stock Options or Other Ownership Interest) – Access. Closure, Inc. , Co. Aptus, Inc. , Ovalis, Inc. , Paragon Medical, Inc. , Pathway Medical Technologies, Inc. , Sage Medical, Inc.

Stent technology: the advantages of both constructions is possible 1980 s 1990 s Balloon Expandable Stents (BES) Self Expanding Stents (SES) Today BES with SES properties Metal Stent Design Evolution BES: Accurate single step but deformation an issue for peripheral applications SES: Crush resistant and better wall apposition but less accurate and multiple steps required CAUTION – Device not approved for sale or distribution Citation stent

Finite element analysis (FEA) of current tube-cut nitinol stents CAUTION – Device not approved for sale or distribution

Inversion Point™ Stent Technology achieves bistability in nitinol FEA of 2 Citation stent cells crimping CAUTION – Device not approved for sale or distribution

Nitinol bistability allows new considerations in stenting Balloon Expandable Non-Crushable Stent • The accuracy of balloon placement • Direct stenting with nitinol • 1 -2 less steps per stent • Less radiation exposure • Cost savings (less balloon use) Value of bistable stenting is in the system potential to match the “ease of use” value of rapid exchange CAUTION – Device not approved for sale or distribution

Bistable nitinol conforms to vessel contours OCT of Citation stent in porcine iliac (accommodation of bladder compression between 11: 00 and 2: 00) CAUTION – Device not approved for sale or distribution

Comparison of stent classes Conventional SS or Co. Cr Stent Conventional Ni. Ti Stent Bistable Ni. Ti Stent Non-deformable No Yes Conformability Yes No Yes Delivery system flexibility Procedure steps 1 to 2 2 to 3 1 to 2 Accuracy Direct stenting CAUTION – Device not approved for sale or distribution

What about vessel length and conformational changes? SFA and popliteal foreshortening Two cadaver studies evaluated the % decrease in stent length with axial load. Results showed reduction of stent length by 3% to 25%. Journal of Vascular Surgery 2008; 48: 435 -440

Consequences of a stent with limited axial compression ability during knee bend Stent distal edge

SFA nitinol stent fracture and restenosis due to axial compression and stent yield or “hinge points”

TRIAD™ stent system: A next-generation SFA stent Bistability Controlled Ring Segmentation Nitinol TRIAD™ CAUTION – Device not approved for sale or distribution

Controlled Ring Segmentation Design • Design goals – Provide for longitudinal (axial) and torsional flexibility required by SFAs – Lessen wall shear stress interaction with artery – Maintain value of bistability • Accuracy, less steps, cost savings, less radiation exposure, deliverability CAUTION – Device not approved for sale or distribution

TRIAD™ Pre-Clinical Animal Study

Bistable Stent Family Accura cy Less Steps Delivery Cost Savings Iliacs SFAs • Controlled Ring Segmentation for axial conformability Popileteal • Controlled Ring Segmentation for axial conformability Carotids • Spot stenting of ICA • . 014” BDC delivery to reduce sheath prolapse risk Venous • Lower profile, large Ni. Ti stents Neuro • Lower profile, microcatheter compatibility Grafts CAUTION – Device not approved for sale or distribution Other • Percutaneous option

Maturation of the Technology: Today • Cobalt alloys (low profile and less elastic recoil): Low-profile coronary stent with a prohealing coating has completed EU safety/feasibility trial ¡ Medium and large peripheral stents in pre-clinical assessment ¡ • Shape memory alloys (balloon expandable crush resistant): ¡ Iliac stent completing pre-clinical studies CAUTION – Device not approved for sale or distribution

Maturation of the Technology: Implications for Tomorrow • SFA Segmented: Initiated pre-clinical testing • SFA Helical: In design phase • Future: Carotids, stent grafts, low profile valve rings… CAUTION – Device not approved for sale or distribution

Conclusion Bistable stenting offers a new class of stents that promises to combine the benefits of today’s BE and SE stents Additionally, bistability allows for clinical and engineering applications not previously possible • Accurate spot stenting • Direct stenting of Ni. Ti • Segmented stent design CAUTION – Device not approved for sale or distribution