Self-expanding stent shows benefit in study-Stentys

Fri Mar 8, 2013 6:00pm EST

* Stentys device has lower death rates than other products

* Aims to sell device in more European countries

* US trial to start in next few weeks

By Elena Berton and Noëlle Mennella

PARIS, March 9 (Reuters) - Stentys said on Saturday that a study has shown its self-expanding stents for keeping blood vessels open have lower mortality rates than other conventional devices.

The French medical technology firm said the study paves the way to new markets for its tiny mesh tubes - which unlike conventional stents fit into the contours of blood vessels, change shape and adapt their diameters as vessels dilate and initial clots dissolve.

"The next step is to open other markets in Europe and in the Middle East, Latin America and maybe Asia," Chief Executive Gonzague Issenmann told Reuters.

Stentys said it also aims to break into the $3 billion U.S. market, the world's largest for stents.

Data from a study of 1,000 heart patients showed the Stentys device had lower rates of major cardiac events, including death, than conventional stents, Stentys said.

These rates were 9.3 percent for self-expanding stents compared with 11.1 percent for conventional stents, according to the study presented at the American College of Cardiology congress in San Francisco.

Average cardiac death rates were 2 percent compared with rates of 3.9 percent for conventional stents from other published studies.

Stentys is starting a new clinical trial in the United States in the next few weeks with the aim of getting U.S. Food and Drug Administration (FDA) approval as early as 2015.

The company would seek a partner to market the device in the United States if it gets approval, Issenmann said.

It already sells its devices in several European countries including France, Germany, Switzerland, the Netherlands, Italy and Spain.

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