New Stent Designs Applicable for Renal Intervention John R. Laird, MD Professor of Medicine Medical Director of the Vascular Center UC Davis Medical Center

John R. Laird, Jr., MD DISCLOSURES Consulting Fees Abbott Vascular, AngioScore, Inc., Ardian, Inc., Boston Scientific Corporation, Cordis, a Johnson & Johnson company, Lutonix, Medtronic CardioVascular, Inc. Ownership Interest (Stocks, Stock Options or Other Ownership Interest) Angioslide, BioCardia, Inc., NexGen, NovoStent, ReVascular Therapeutics, Inc. I intend to reference unlabeled/unapproved uses of drugs or devices in my presentation. I intend to reference off-label use of stents.

The Atherosclerotic Milieu

The Goal To Improve patient safety and outcomes following renal artery intervention by: More accurately and safely treating the ostial atherosclerotic plaque Better protecting the kidney against atheroembolic debris Embolic protection device Stents that provide better plaque coverage

Unique Challenges with Aorto-Ostial Stenting Subclavian SVG RCA Left Main Renal Inaccurate Placement Not predictable Difficult to visualize the ostium Geometric Mismatch Tube shaped stent into funnel shaped anatomy Incomplete scaffolding Re-Cross Difficulties Stent damage or migration Guidewire entanglement in stent struts

BullsEye Ostial Stent System BullsEye Visualized with CTA Flared stent tailored to the unique anatomy of the aorto-ostial junction Delivery system enables rapid, precise ostial deployment Straight Stent: ~2mm Aortic Protrusion BullsEye Flare Conformed to Aorta

BullsEye Technology OSTIAL POSITIONING Tactile & Visual Location Geographic Miss Contrast Procedure Time Ostial Locating Balloon OSTIAL CONTOURING Funnel Geometry Mimics Ostial Anatomy Conformable Flare Ease of Re-Cross Stent Damage/Migration Ostial Coverage Function Feature Clinical Benefit

BullsEye Stent Procedure

Post Procedure Result

BOSS-I Acute Results Technical Success 100% (25/25) Acute Procedural Success Procedural Complications (dissection, thrombosis, perforation) 0% (0/25) Major Adverse Events (death, target lesion revascularizations, embolic events) Procedure time (mean) 26 minutes Successful stent positioning & deployment (angiographic confirmation) 100% (25/25) Successful re-cross of lesion/stent 100% (25/25)

BOSS-I 12M Results MAE (%) 8.0 (2/25) Death 0% (0/25) TLR 8.0% (2/25) (189 and 257 days post treatment) 8.0% (2/25) Embolic Events Blood Pressure (mm Hg) Baseline 12 Months Systolic Diastolic 157 ± 22 82 ± 10 141 ± 18 83 ± 8 Antihypertensive Medications 3.0 ± 1.6 2.5 ± 1.4 Serum Creatinine (µmol/l) 100 ± 43 103 ± 34

Other Promising Stent Technologies ePTFE covered balloon expandable stent (Atrium Medical) Micromesh technology – Sesame stent (Palmaz Scientific)

Future Product Small Diameter Covered Stent 316L– Totally Encapsulated Covered Stent Rapid Exchange - .014 5Fr introducer compatibility 6Fr guidecatheter compatibility Diameters: 4.0 to 7.0mm Lengths: 12, 16, 22, 29 Currently under development

Covered stent for renal instent restenosis The Role of Stent Grafts: Iliac, SFA, and Renal Intervention Gary Ansel, MD Riverside Methodist Hospital TCT 2009 Covered stent for renal instent restenosis 10 patients (12 renal arteries) Average follow-up 10.8 months (6-22) Duplex or angiographic follow-up in 100% Patency = 100%

Covered Renal Stents During Fenestrated EVAR Cases

518 renal stents in 287 patients received either bare or covered stent Revised Duplex Criteria and Outcomes for Renal Stents and Stentgrafts Following Endovascular Repair of Juxtarenal and Thoracoabdominal Aneurysms Journal of Vascular Surgery 2009 Volume 49, Number 4 Mohabbat W, Greenberg R, Mastracci T, Gornick H, Morales P, Cury M, Pfaff K, Hernandez A Cleveland Clinic Foundation, Cleveland, Ohio A prospective database of patients treated with fenestrated and branched endografts (2001-2006), all patients had CT and duplex follow-up 518 renal stents in 287 patients received either bare or covered stent Mean follow-up 25months Patients bare metal stents were more likely to develop in-stent stenoses than those treated with covered renal stents (HR 0.4, 95% CI 0.2-0.9, p=0.04). Conclusion: Renal covered stents are associated with a lower incidence of in-stent stenosis, compared to bare metal stents

Covered stent with 3 micron metal mesh Micromesh technology – Sesame stent (Palmaz Scientific)

Summary Better protection for the kidney and improved safety of renal artery intervention is paramount There is a need for dedicated renal stents designed specifically for aorto-ostial renal anatomy Regulatory hurdles are substantial