Stentys is celebrating more positive clinical data stemming from the use of its self-apposing stent to treat acute heart attacks.
The French company, citing results from its APPOSITION III trial, noted a 2% mortality rate after one year and a 1.3% rate of new heart attacks. Stentys said its stent generated promising data in a wide range of patients, including diabetics, and performed equally in women and men, which can be unusual for stent procedures. APPOSITION III assessing the stent’s long-term performance in 1,000 patients across Europe who have suffered heart attacks.
Stentys’ good news, presented at EuroPCR in Paris, will fuel expanded testing of the product, which has had European CE mark status since 2010. That data will also inform enrollment in the company’s APPOSITION V trial in the U.S. and globally, the company said. That trial began in April and should involve 880 patients, said CEO Gonzague Issenmann in January while attending the J.P. Morgan Healthcare Conference in San Francisco.
The global stent market is hotly competitive, particularly in Europe. But Issenmann said that Stentys, which raised $45 million earlier this year on the Euronext exchange, will stand out because its stent is designed to eliminate the need for different sizes. And most of the major stent manufacturers have rushed out new stent sizes in recent months in order to stand out.
“We can play our own sheet of music because we have something that no one else has,” Issenmann told us at JPM. In his official statement included as part of the company’s data announcement, Issenmann said that the new results will likely help expand adoption of a product that “is becoming an invaluable tool for cardiologists in Europe for treating patients with AMI.”
Source: Stentys self-apposing cardiac stent gets the job done at one year – FierceMedicalDevices http://www.fiercemedicaldevices.com/story/stentys-self-apposing-cardiac-stent-gets-job-done-one-year/2013-05-23#ixzz2UXrnlvon