Stentys Starts U.S. Cardiac Device Trial

In what is shaping up to be a blockbuster year for Stentys S.A., whose revenues for the first nine months of 2012 are up 88 percent compared with last year, the company has received investigational device exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to conduct a pivotal clinical trial in the United States. If successfully completed, the trial will enable the company to apply for marketing approval of the Stentys Self-Apposing stent, which is sold in Europe. The stent is designed for the treatment of acute myocardial infarction (AMI).

The trial will be named the Apposition V clinical trial, and will enroll up to 880 heart attack (ST-elevation myocardial infarction, or STEMI) patients at 50 sites in the United States. The randomized trial is designed to compare the clinical outcome of patients treated with the bare metal Self-Apposing Stent versus Abbott’s Multi-Link Vision stent at 12 months after the procedure. The trial is expected to begin in early 2013.

The trial Stentys ran in Europe was called Apposition III, and it also took place in 50 sites across the continent in about 1,000 patients. This trial was designed to assess the long-term performance of the Self-Apposing stents in routine clinical practice for STEMI patients. The interim analysis was conducted on the first 600 patients at the one-year point and showed a death rate of 1.7 percent—well below conventional stents’ average of 3.9 percent. The lower death rate maintained an early clinical gain that was reported in May 2012 at the one-month time point.

“With an AMI global market estimated at $2 billion, this IDE approval represents a significant milestone for the company and an opportunity to expand upon the data gathered to date in our European clinical trials,” said Gonzague Issenmann, CEO and co-founder of Stentys. “The IDE allows us now to progress toward a pre-market application to bring the self-apposing technology to cardiologists and their AMI patients in the United States.”

During a heart attack treatment procedure, the presence of a clot and the natural vessel contraction prevent cardiologists from precisely determining the artery diameter. When selecting a conventional stent size, there is a risk of under sizing, causing malapposition, or oversizing, which then can cause a vessel wall injury. These factors can lead to an increased risk of a recurring heart attack. According to Stentys, the Self-Apposing stent is designed to address that ‘stent sizing dilemma’ by fitting into the contour of a blood vessel. The shape and diameter of the stent reportedly adapts as the vessel dilates and the initial clot dissolves during the post-AMI phase.

Issenmann attributed Stentys’ stellar growth this year to the success of the stent’s performance: “Our third-quarter sales performance is in line with our market plan and our robust growth is suggestive of the potential we believe our Self-Apposing stent platform represents, particularly in clinical settings such as AMI.”

Stentys is focused on developing and commercializing technology for the treatment of acute myocardial infarction and complex coronary artery disease. The company is based in Paris, France, with U.S. offices in Princeton, N.J.

Photo of Stentys Self-Apposing stent courtesy of Stentys.