Biotronik's Pro-Kinetic Energy CoCr Coronary Stent System Receives FDA Approval

February 15, 2017—Biotronik announced it has received US Food and Drug Administration (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 µm. The company also notes that the unique double-helix design results in flexibility and deliverability even in challenging vessels.

"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," commented Saurabh Gupta, MD, Principal Investigator for the pivotal US trial in the company’s announcement. "It's a new generation bare-metal stent with an innovative design and biocompatible coating that has superb deliverability. I'm pleased that Pro-Kinetic Energy will now be a treatment option for patients and physicians here in the United States."

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.