FDA approval granted for BIOTRONIK’s ultra-thin PRO-Kinetic energy Cobalt chromium coronary stent system
LAKE OSWEGO, Oregon, US and BUELACH, Switzerland—PRO-Kinetic Energy Cobalt Chromium (CoCr) Coronary Stent System from BIOTRONIK gained FDA approval utilizing results from the BIOHELIX-I clinical study. This stent, which has already been used to treat more than 650,000 patients worldwide, is now available in the US.
The PRO-Kinetic Energy Cobalt Chromium Bare-Metal Stent is designed to improve coronary luminal diameter in patients with new and reoccurring blockages in the coronary arteries. The ultra-thin, 60 µm* strut thickness of this cobalt-chromium stent allows for optimal deliverability under the most extreme conditions of tortuosity and calcification. It is indicated for patients who have a blockage in arterial vessels between 2.25 and 4.0 mm in diameter and lesion lengths up to 31 mm.
The prospective, non-randomized, 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 revascularization.
“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 Dr. Saurabh Gupta principal investigator for the pivotal US trial. “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 US.”
The FDA approval of the PRO-Kinetic Energy stent system is a landmark for BIOTRONIK as it is the company’s first coronary stent to be commercially marketed in the US. “We’re proud to make the PRO-Kinetic Energy stent available to physicians and their patients in the US,” commented Marlou Janssen, President BIOTRONIK, Inc. “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.”