Biotronik Reports Promising Clinical Trial Results for Astron Stent

Biotronik SE & Co. KG steadily is gaining the clinical evidence it needs for U.S. Food and Drug Administration (FDA) approval of its investigational Astron self-expanding stent.

In a recent study, the nitinol stent designed for the narrowing of the leg’s iliac or external arteries met its clinical endpoint.

During the 162-patient trial, the rate of major adverse events was 2.1 percent at 12 months post-procedure, or below the goal of 15 percent, 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 percent 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,” said Mark Burket, M.D., of the University of Toledo Medical Center (Ohio). “As the results of Bioflex-I show, Astron will be a helpful addition to the interventionalist’s toolkit once approved for use in the U.S.”

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 percent, meaning nearly 90 percent of patients did not experience severe renarrowing of their iliac artery (restenosis) after the procedure.

The Astron stent has had a CE Mark for use in Europe since 2003 and is available in 45 countries. Biotronik claims it already has treated more than 55,000 patients worldwide with the stent.

The Astron self-expanding nitinol stent system is designed to provide the specific performance characteristics required for iliac arteries. Astron features a peak-to-valley stent design with S-articulating connecting bars to provide multi-directional flexibility while avoiding fish-scaling in tortuous arteries. Furthermore, the segmented architecture and strut thickness are optimized to provide sufficient chronic outward force. Astron stents are coated with proBIO, a silicon carbide layer that reduces metal ion release from the stent surface into the surrounding tissue.

Devices for iliac artery diseases on the market include Boston Scientific’s Express LD Iliac and Biliary stent. And in January, the FDA approved Covidien plc’s Protégé GP Self-Expanding Peripheral Stent system.

Biotronik is based in Berlin, Germany, and has a global workforce of more than 5,600 employees. Its U.S. headquarters is located in Lake Oswego, Ore.