FDA approves Pro-Kinetic Energy cobalt chromium (CoCr) coronary stent system.- Biotronik

Biotronik announced it has received FDA approval for its Pro-Kinetic Energy cobalt chromium (CoCr) coronary stent system. The company gained FDA approval using the results of the BIOHELIX-I clinical trial.In their announcement, Biotronik explained that the Pro-Kinetic Energy CoCr bare-metal stent is designed to improve coronary luminal diameter in patients with new and recurring blockages in coronary arteries. The stent is indicated for patients who have a blockage in arterial vessels between 2.25 and 4 mm in diameter and lesion lengths up to 31 mm. Biotronik describes the stent as coated with proBio, a silicon carbide layer that reduces metal ion release from the stent surface into the surrounding tissue, and featuring ultrathin struts of only 60 �m. The company also notes that the unique double-helix design results in flexibility and deliverability even in challenging vessels.

The BIOHELIX-I trial is a prospective, nonrandomized, multicenter study assessing the Pro-Kinetic Energy stent�s safety and efficacy. Per the company�s announcement, 329 patients were enrolled in the study across 33 sites worldwide. Results of the study found a target vessel failure rate of 9.06% at 9 months, which was less than half the identified goal of 18.7%. Biotronik noted these results were consistent with previous Pro-Kinetic Energy trials.

Comment: Biotronik secured CE Mark recommendation on 3 March 2009 for the Pro-Kinetic (PK) Energy Stent System with Probio silicon carbide coating.