BIOTRONIK introduces Its first stent in U.S.
BIOTRONIK has just landed its first FDA approval for a coronary stent. The PRO-Kinetic Energy CoCr metal stent is intended for placement within narrow arteries, only between 2.25 and 4 mm in diameter, and features struts that are nearly microscopic at 60 µm in width. The narrow struts and the helical design make the stent very flexible for easier delivery through tortuous vasculature.
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.
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