Biotronik’s Pro-Kinetic Energy bare metal stent has received FDA approval, which is based on the results of the BIOHELIX-I clinical study. Therefore, the stent, which a press release reports has already been used to treat more than 650,000 patients worldwide, is now available in the USA.
The stent is designed to improve coronary luminal diameter in patients with new and reoccurring blockages in the coronary arteries, and is indicated for patients who have a blockage in arterial vessels between 2.25mm and 4.0mm in diameter and lesion lengths up to 31mm. Also, the press release states that the “ultra-thin” (60µm) strut thickness of the stent “allows for optimal deliverability under the most extreme conditions of tortuosity and calcification”.
The prospective, non-randomised, multicentre BIOHELIX–I trial evaluated the safety and efficacy of the Pro-Kinetic Energy stent. A total of 329 patients were enrolled at 33 sites worldwide. At nine months, the stent was associated with a target vessel failure rate of 9.06%—less than half of the identified performance goal of 18.7%. These results, the press release comments, confirm the clinical success found in other PRO-Kinetic Energy trials. One of these, the ENERGY Registry, studied more than 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.
Saurabh Gupta principal investigator for the pivotal US trial comments: “The BIOHELIX-I study results show that the Pro-Kinetic Energy stent is a great choice for safely treating coronary artery disease and minimising the potential for future adverse events. It is 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 USA.”
The FDA approval of the Pro-Kinetic Energy stent system is a landmark, according to the press release, because it is the company’s first coronary stent to be commercially marketed in the USA. “We are proud to make the Pro-Kinetic Energy stent available to physicians and their patients in the USA. 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,” comments Marlou Janssen, President Biotronik.