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

2. 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.

3. The Atherosclerotic Milieu

4. 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

5. 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

6. 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

7. 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

8. BullsEye Stent Procedure

9. Post Procedure Result

10. 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)

11. 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

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

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

14. 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%

15. Covered Renal Stents During Fenestrated EVAR Cases

16. 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 ( ), 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 , p=0.04).
Conclusion: Renal covered stents are associated with a lower incidence of in-stent stenosis, compared to bare metal stents

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

18. 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