STENTYS Enrolls First 250 Patients, Half Of Apposition III Study Of Its Self-Apposing Stent For Treatment Of Heart Attacks

Main Category: Cardiovascular / Cardiology
Also Included In: Heart Disease;  Medical Devices / Diagnostics
Article Date: 02 May 2011 - 8:00 PDT


STENTYS S.A. (STNT.PA), a medical technology company that is commercializing a new generation of innovative stents to treat Acute Myocardial Infarction (AMI), announced today that it has reached the mid-point of its international APPOSITION III study of its Self-Apposing Stent, with 250 patients now enrolled out of a total of 500. The trial primary endpoint is Major Adverse Cardiac Events (MACE) at 12 months post-procedure.

"All cardiologists are extremely excited to be part of the APPOSITION III study and to routinely use the STENTYS Self-Apposing Stent in treating AMI patients," said study investigator Dr. Robert Jan van Geuns, M.D., Ph.D., Thorax Center at Erasmus Medical Center, Rotterdam, the Netherlands.

"Malapposition is a well-established cause of thrombotic events and repeat myocardial infarction, but it can be eliminated with the use of our Self-Apposing Stent. APPOSITION III, designed as a large scale prospective clinical study, will substantiate that our stent is the solution for treating heart attack patients," added Gonzague Issenmann, CEO and co-founder of STENTYS.

The STENTYS stent represents a major breakthrough compared to conventional stents when treating heart attacks: it is self-apposing, i.e. it "fits snugly" into the contour of a blood vessel, and its shape and diameter adapt to the anatomic changes of the coronary arteries during the post-AMI phase. The APPOSITION II randomized trial compared the STENTYS Self-Apposing Stent with a conventional, market-leading stent in patients suffering a heart attack. It showed that, three days after an AMI, 28% of patients treated with conventional stents displayed significant malapposition, meaning that the stent was not completely in contact with the artery wall. Malapposition puts AMI patients at significant risk of potential fatal complications such as a blockage of the stent (in-stent thrombosis). In contrast, none of the patients treated with the STENTYS stent had stent malapposition.

Acute Myocardial Infarction (AMI) affects 100,000 people each year in France and an additional 900,000 people in the United States and represents an annual worldwide market of approximately $2 billion.

Source:
STENTYS S.A.

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