Technology | Stents Bare Metal | February 15, 2017

FDA Approves Biotronik's PRO-Kinetic Energy Cobalt Chromium Coronary Stent System

Results from BIOHELIX-I study show target vessel failure rate less than half of identified performance goal

Biotronik, PRO-Kinetic Energy cobalt chromium coronary stent system, FDA approval

February 15, 2017 — The PRO-Kinetic Energy Cobalt Chromium (CoCr) Coronary Stent System from Biotronik has gained U.S. Food and Drug Administration (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 United States.

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 the 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 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 percent, less than half of the identified performance goal of 18.7 percent. 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 percent, including a 4.9 percent 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 Saurabh Gupta, M.D., principal investigator for the pivotal U.S. 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 U.S."

The FDA approval of the PRO-Kinetic Energy stent system makes it the company's first coronary stent to be commercially marketed in the United States.

For more information: www.biotronik.com

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