‘OPEN I’ Study Demonstrates Safety of the Stentys Stent at 30-day Follow-up of 40 Patients

PARIS--(BUSINESS WIRE)--Medical device pioneer Stentys announced today that clinical data from the ‘OPEN I’ clinical study using its bifurcated stent was presented at the Transcatheter Cardiovascular Therapeutics (‘TCT’) 2008 symposium, an international medical meeting on cardiovascular interventions. The data — presented by Stefan Verheye, M.D., Department of Cardiology, Middelheim, Antwerp, Belgium — considered safety results 30 days post-implantation of the Stentys bifurcated stent in a total of 40 patients.

The stent was successfully deployed in 39 of the 40 patients, leading to an overall 98% procedural success rate. An increase of cardiac enzymes (non-Q wave MI) was observed during only one procedure out of 40, without any clinical consequences for the patient. One other patient had to undergo balloon angioplasty one week after the initial procedure. Dr. Verheye concluded that the Stentys stent is safe, provides side branch access and allows provisional treatment of branch vessels. The stent with its self-expanding properties conforms “very nicely to the complex peri-carinal vessel anatomy”.

“These exciting results lead me to believe that the Stentys bifurcated stent has the potential to make the treatment of blocked coronary artery bifurcations as simple and effective as a conventional stenting procedure,” said Dr. Verheye.

“The Open I study demonstrates that the Stentys bifurcated stent can be simply and safely implanted in patients with complex bifurcation lesions,” concluded Stentys’ CEO and co-founder, Gonzague Issenmann. “The Stentys stent offers a simple consistent stenting strategy, the ‘enhanced provisional technique’ that allows cardiologists to keep all options open throughout the procedure for optimal vessel treatment.”

The annual TCT medical symposium has become the primary means by which state-of-the-art techniques and training are disseminated to interventionalists around the world, allowing them to bring innovative breakthroughs to their practices and dramatically improve the lives of their patients with cardiovascular disease.

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. The OPEN I trial demonstrated that the procedure is simple and safe.

Contact:

Ronald Trahan Associates Inc. Ronald C. Trahan, +1-508-359-4005 APR, President

Source: Stentys