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 News Release - September 3, 2008

Stentys Appoints Rene Spaargaren, MD, as Chief Medical Officer

ev3's former Vice President of International Clinical Affairs will oversee clinical development of Stentys' stent for treatment of blocked coronary artery bifurcations

"Dr. Spaargaren's extensive experience in leading the clinical development of cardiovascular technologies while working for companies such as ev3, Boston Scientific and Medtronic will certainly fortify our ongoing clinical development efforts."

- Gonzague Issenmann, Co-Founder and CEO, Stentys

PARIS--(HSMN NewsFeed)--Stentys ( announced today that it has appointed Dr. René Spaargaren as its Chief Medical Officer (CMO). Stentys is developing the world’s first next-generation drug-eluting stent for treatment of blocked coronary artery bifurcations so that hundreds of thousands of patients might avoid open-chest surgery.

Previously at ev3, Dr. Spaargaren was Vice President of International Clinical Affairs since 2002, where he was responsible for driving new product development from R&D to acceptance by the medical community and launch into international markets. Prior to ev3, Dr. Spaargaren served for seven years (1995-2002) with Boston Scientific Corp. as Medical Director, Europe; and for three years (1992-1995) as Clinical Manager, Europe, with Medtronic (Cardiac Assist Venture).

“Dr. Spaargaren has achieved a great deal of success over the past six years at ev3 in helping the company establish itself as a market leader in several fast-growing vascular market-segments,” said Stentys’ CEO and co-founder, Gonzague Issenmann. “No doubt, he will play a critically important role in helping to establish that the Stentys bifurcation stent is as easy for cardiologists to use as conventional stents—but that our bifurcation stent is designed to provide superior treatment options by enabling full opening of the side branch.”

Coronary artery disease is caused by fatty lesions that narrow the coronary artery’s inside diameter (stenosis), consequently reducing the blood flow and depriving the heart muscle of oxygen. The dramatic consequence of this blockage is an often-lethal myocardial infarction (heart attack). Bifurcation is the area where one main vessel branches out into two smaller vessels, one being the continuation of the main vessel, and the other often referred to as the side branch. Narrowings at a bifurcation site are quite common. Indeed, 18 percent of percutaneous coronary interventions involve a bifurcation stenosis. Of those, restenosis (re-occurrence of the blockage) occurs in 20-25 percent of bifurcations treated with drug-eluting stents (DES).

The patent-pending innovation of Stentys’ bifurcated stent is that the stent-opening for the side branch can be created anywhere in the stent after it is implanted in the vessel. In short, the procedure’s success is independent from accurate positioning. The Stentys procedure is performed in three simple steps: (1) Stentys is implanted in the main vessel with an approximate positioning, like a standard stent; (2) the cardiologist chooses the optimal location for the side branch opening by inserting a balloon through the stent mesh, which is a cath lab-standard procedure; and, (3) the balloon inflation disconnects the mesh and creates the opening—Stentys’ self-expanding property allows the in situ modeling of the stent to fit the patient’s unique arterial anatomy.

About Stentys

Based in Paris, Stentys intends to make treatment of blocked coronary artery bifurcations as simple and effective as a conventional stenting procedure. The Company has developed the world’s first next-generation dedicated stent for treatment of blocked coronary artery bifurcations that is designed so that hundreds of thousands of patients might avoid open-chest surgery. To date, the Stentys bifurcated stent has been successfully implanted in patients as part of the OPEN 1 trial, taking routine interventional time to complete; the patients were released from the ICU within hours of implantation of the Stentys bifurcated stent and were discharged from the hospital shortly after the procedure.

Source: Stentys

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