|The Astron Self-Expanding Nitinol Stent--Courtesy of Biotronik|
Biotronik said at the Cardiovascular Research Technologies conference that its investigational Astron self-expanding nitinol stent for the narrowing of the leg's iliac or external arteries met its clinical endpoint, as the company chases FDA approval.
During the 162-patient trial, the rate of major adverse events was 2.1% at 12 months post-procedure, or below the goal of 15%, Biotronik said. The definition of major adverse event constituted 30-day mortality, clinically driven target lesion revascularization (or a repeat procedure) and limb amputation.
The rate of target lesion revascularization was 1.4% at 12 months, according to the release.
"Astron has already proven itself as an excellent treatment option abroad in routine clinical practice for patients suffering from iliac artery disease. As the results of BIOFLEX-I (clinical trial) show, Astron will be a helpful addition to the interventionist's toolkit once approved for use in the U.S.," said principal investigator Dr. Mark Burket of the University of Toledo Medical Center in Ohio in a statement.
Burket presented the results at the Washington, DC, conference.
In addition, Biotronik said the Astron's 12-month patency rate, or the sustained restoration of blood flow through the treated segment of the diseased artery, was 89.8%. That means almost 90% of patients did not experience severe renarrowing of their iliac artery (restenosis) following the procedure.
The Astron stent has had a CE mark for use in Europe since 2003 and is available in 45 countries. Biotronik says it has already treated more than 55,000 patients worldwide.
Devices for iliac artery diseases on the market include Boston Scientific's ($BSX) Express LD Iliac and Biliary Stent. And in January, the FDA approved Covidien's Protégé GP Self-Expanding Peripheral Stent System.
- read the release
- here's information on the conference