First-in-Man Milestone Reported for the Stentys Bifurcated Drug-Eluting Stent.

"The Stentys platform offers great promise in treating blocked coronary artery bifurcations as simply and effectively as a conventional stenting procedure."

Eberhard Grube, M.D., HELIOS Klinikum Siegburg, Germany

PARIS -- Stentys (http://www.stentys.com) announced today that its bifurcated stent was successfully implanted yesterday into a 56-year-old male patient at the HELIOS Klinikum Siegburg in Siegburg, Germany. Stentys has developed the world's first next-generation dedicated drug-eluting stent for treatment of blocked coronary artery bifurcations so that hundreds of thousands of patients might avoid open-chest surgery. This first-in-man medical milestone took routine interventional time to complete; the patient was released from the ICU within hours of the implantation of the Stentys bifurcated stent and was discharged from the hospital shortly after the procedure.

"This clinical achievement corroborates our own certainty that the Stentys bifurcated stent will offer cardiologists the next generation of dedicated bifurcated-stenting procedures," said Stentys' CEO and co-founder, Gonzague Issenmann.

"The Stentys platform offers great promise in treating blocked coronary artery bifurcations as simply and effectively as a conventional stenting procedure," said Eberhard Grube, M.D., Chief of Cardiology and Angiology at HELIOS Klinikum Siegburg and a consulting professor of medicine at Stanford University.

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.

Based in Paris, Stentys intends to make treatment of blocked coronary artery bifurcations as simple and effective as a conventional stenting procedure.