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

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 !)

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.

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

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 Guide Ostial ProTM Cylinder Outside Guiding Catheter Ostial ProTM Being Withdrawn Into 6 Fr.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

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

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

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

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)

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)

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 < 0.0001 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).

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)

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.”

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.

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

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

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)

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).