Biotronik Enrolls First U.S. Patient in Vascular Intervention Study
Biotronik has enrolled the first U.S. patient in its clinical trial evaluating the Osiro hybrid drug-eluting stent. The implant was performed at Thomas Hospital in Fairhope, Ala., the German devicemaker said last week
The global multicenter trial’s primary endpoint is target lesion failure at 12 months following surgery. It plans to enroll about 1,330 patients across 150 sites in the U.S., Canada, Europe, Israel and Asia Pacific. The U.S. arm is operating under an investigational device exemption, the company says.
Available in Europe since 2011, the Osiro device combines passive and active stent components that minimize interaction between the metal stent and surrounding tissue.
In the U.S., Biotronik is best known for its cardiac rhythm management products, but is hoping to expand there by adding a vascular intervention division. — Jason Scott