1. The “Ostial ProTM” Stent Positioning Device A Tool for Precise Aorto-Ostial Stent Placement
CRT
Washington, D.C.
February 23, 2010
Tim A. Fischell, M.D. FACC
Professor of Medicine, Michigan State University
Director of Cardiovascular Research
Borgess Medical Center
Kalamazoo, Michigan

2. Rationale For Development of Ostial Stent Positioning System
Anatomy of stent positioning at aorto-ostial location is very challenging.
Angiographic landmarks via angiography are often ambiguous or misleading.
This results in frequent mis-placement of stent: 1) too distal, either not recognized -> restenosis or requires additional (overlapped) stent ($$). 2) too proximal, protrudes into aorta so you may never be able to re-engage the vessel again (metal sticking out !)

3. Rationale For Development of Ostial Stent Positioning System
Need for correct positioning is even more critical in new era of DES (cost and drug overlap issues).
Ostial stent positioning device should be simple to use, nearly foolproof, provide positioning to ± 0.5 mm in all cases, and compatible with ~ all coronary and renal stents, all guiding catheters 6 Fr or larger.
Market for device includes RCA and left main ostials, SVG aorto-ostials, renal, SMA, IMA, celiac & vertebral ostial lesions -> estimated worldwide market = > 290,000 cases in 2010.

4. A B Problems With Ostial Stent Placement A B IVUS of body of stent
True RCA Ostium
Restenosis 4 Months After Ostial RCA Stent
Placement A
Lumen at true ostium
No stent placed there !
After Repeat
Stenting 4.5 mm
Bx Hepacoat B

5. Ostial ProTM Stent Positioning System in 6 Fr. Guide
Ostial ProTM Cylinder Outside Guiding Catheter
Ostial ProTM Being Withdrawn Into 6 Fr. Guiding Catheter
Ostial ProTM Expanded Position at Tip of Guiding Catheter
Ostial ProTM Expanded Position Simulation of Legs Against Aortic Wall

7. Ostial ProTM Stent Positioning System
Stent Alignment
Stent Deployment
Stent Flaring
“Conical Flaring”

9. Ostial Pro Device First U.S. Ostial Pro Positioning Case Calcified RCA
Ostial Lesion (pre)
After Stent)
Long Axis IVUS Stent After Os Pro Position
Calcified RCA
Ostial Lesion (pre)
After Stent Exactly at Ostium
True RCA Ostium
Proximal Stent edge

10. Ostial ProTM Stent Position in SVG
Ostial ProTM Legs Deployed Stent Balloon Inflated
Ostial ProTM Legs Deployed Pre-Deployed Stent Distal
Ostial ProTM Legs Deployed SDS Positioned
Final Angiogram SVG After Stent Deployed

11. Ostial ProTM Stent Position Unprotected LM
Angiogram of LMCA Prior to Stenting
IVUS at Ostium
Angiogram of LMCA Post Stenting
Long Axis IVUS of LMCA After Ostial ProTM Stent Positioning
True Ostium
False Ostium
Proximal Stent Strut(s)

12. Ostial ProTM Stent Position in Renal Artery: St. John’s Hospital
Ostial Renal Pre- Treatment
Final Angiogram of Renal After Ostial ProTM Stent Positioning
Proximal Flaring of Stent Edge
Positioning of Stent With Ostial ProTM
True Ostium Renal Artery
Proximal Stent Strut(s) (Case by Tom Davis. M.D., St John’s Hospital, MI)

13. Results Ostial ProTM vs Control Cases
Variable
RCA Ostial
Left Main Ostial
SVG or LIMA Ostial
Distal/ Proximal Miss
Total Misses
(> 1 mm)
Ostial ProTM Cases
N = 30 17 6 7
0/0
0/30 (0%)
Control Cases 19 5
14/4
18/30 (60%)*
* - p < vs. Ostial Pro Cases (Fisher Exact Test); Note - in 14 distal misses, 9 Rx. with POBA, 5 re-stented, with 2/5 second stents missed proximally. Overall 6/30 control cases could not be re-engaged with guiding catheter vs. 0/30 Ostial Pro cases (in press J Invasive Card, 2/09).

14. QCA Data Showing Stent “Flaring” at True Ostium*
QCA Measurement (mean) mm
Final Diameter
At True Ostium
MLD Baseline
MLD After Stent
Final RVD
* - mean diameter at true ostium after Ostial Pro = 29±6% larger than stent MLD (p < 0.001)

15. FDA Regulatory Status Indications For Use
510 (k) Cleared
Indications For Use
“The Ostial Pro Stent Positioning System is intended for use in aorta-ostial procedures to introduce and position catheters, stents and other interventional devices within the coronary and peripheral vasculature. In addition, the Ostial Pro Stent Positioning System is intended to facilitate the alignment of interventional devices and function as an alignment tool.”

16. Ostial ProTM Positioning System
Conclusions
Ostial ProTM Positioning System
The Ostial ProTM is a simple tool compatible with contemporary guiding catheters and stents to facilitate precise stent implantation in aorta-ostial lesions.
This tool has been used with excellent results in the first in man clinical series. 0/30 misses with Ostial Pro vs. 18/30 missed ostia in historical controls (p<0.0001).
The device is commercially available in U.S. with > 1,500 cases performed to date (coronary, renal, SMA,…).
Manuscripts describing the first successful clinical cases have been published in Catheterization and Cardiovascular Interventions and J Inv Card.

18. Disclosures
Co-inventor of Ostial Pro positioning device, licensed to Ostial Solutions, LLC.
Co-founder of Ostial Solutions, LLC.

19. Ostial ProTM Stent Position Unprotected LM
Ostial ProTM Legs Deployed Outside Ostium
Angiogram of LMCA Prior to Stenting
Angiogram of LMCA Post Stenting
Ostial ProTM Legs Deployed On Aortic Wall
True Ostium
False Ostium
Angiographic Site of Lesion

20. Ostial ProTM Stent Position in SVG
Angiogram of RCA Prior to Stenting
IVUS at Ostium
Long Axis IVUS of RCA After Ostial ProTM Stent Positioning
Angiogram of RCA Post Stenting
True Ostium
Case #4
Proximal Stent Strut(s)

21. Objective of Current Study
We evaluated the stent positioning obtained with 30 consecutive, first in man, Ostial ProTM stent positioning cases for the treatment of coronary aorto-ostial stent placement, using IVUS (n=28) and QCA (n = 30), to assess the final result.
The results with the Ostial ProTM stent positioning system were compared with consecutive historical control cases for treatement of coronary aorto-ostial lesions without the use of the positioning system (n = 30).