BIOTRONIK introduces Its first stent in U.S.

BIOTRONIK’s proBIO silicon carbide coating protects the metal, preventing ion release that can lead to platelet aggregation and resulting in thrombosis. The PRO-Kinetic has already been implanted in over 650,000 patients around the world, but a separate study had to be conducted for the FDA to review. Here are some details about that according to BIOTRONIK:

The prospective, non-randomised, multi-center BIOHELIX–I trial evaluated the PRO-Kinetic Energy Cobalt Chromium Bare-Metal Stent’s safety and efficacy. A total of 329 patients were enrolled in 33 sites worldwide. At nine months, the stent demonstrated a target vessel failure rate of just 9.06%, less than half of the identified performance goal of 18.7%.

These positive results confirm the clinical success found in other PRO-Kinetic Energy trials. One of these, the ENERGY Registry, studied over 1,000 patients with complex lesions. At 12 months, the stent showed a low rate of major adverse cardiac events at 8.1%, including a 4.9% rate of target lesion revascularisation.