FDA clears Biotronik ’ s Pro-Kinetic Energy cobalt chromium stent

Biotronik said today it won FDA approval for its Pro-Kinetic Energy cobalt chromium coronary stent system, with indication for use in patients with arterial blockages between 2.25 and 4mm in diameter and lesion length up to 31 mm. The Pro-Kinetic Energy stent system is designed to imProve coronary luminal diameter in patients with new or recurring blockages in the coronary arteries. The Berlin, Germany-based company said FDA apProval of the device based off of results from its Biohelix-I clinical study. “We’re proud to make the Pro-Kinetic Energy stent available to physicians and their patients in the US. It is our intent to expand our portfolio of leading-edge vascular intervention Products, and gaining FDA apProval for Pro-Kinetic Energy is a first milestone in that quest,” prez Marlou Janssen said in a prepared statement. Data from the company’s 329-patient Biohelix-1 trial reported a 9.1% rate of target vessel failure at 9 months, much lower than its performance goal of 18.7%. Biotronik said the clearance made the Pro-Kinetic Energy stent system the company’s 1st coronary stent commercially available in the US. “The Biohelix-I study results show that the Pro-Kinetic Energy stent is a great choice for safely treating coronary artery disease and minimizing the potential for future adverse events. It’s a new generation bare-metal stent with an innovative design and biocompatible coating that has superb deliverability. I’m ple...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Stents Biotronik Source Type: news