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

Related Content

National Academy of Engineering, Ohio University Award 2019 Russ Prize
News | Cath Lab | January 03, 2019
Ohio University and the National Academy of Engineering announced the 2019 Fritz J. and Dolores H. Russ Prize will be...
Videos | Cath Lab | January 03, 2019
This is walk through inside one of the cardiac hybrid cath labs at the...
Videos | Cath Lab | January 03, 2019
This is the newest cardiac cath lab at the ...
Study Finds Effective Treatment for Coronary Slow Flow
News | Cath Lab | December 27, 2018
Patients who arrive at the hospital with heart-attack-like symptoms have had little recourse for their chest pain if...
Shockwave Announces Collaboration With Abiomed on Physician Training
News | Cath Lab | December 14, 2018
Shockwave Medical announced a new investment and collaboration agreement with Abiomed Inc. As outlined by the agreement...
Sponsored Content | Videos | Cath Lab | October 24, 2018
Michael Flaherty, M.D., discusses a study published in Circulation Research which finds that use of hemodynamic suppo
Philips Showcases Integrated Solutions for Cardiovascular Care at TCT 2018
News | Cath Lab | September 20, 2018
At the Transcatheter Cardiovascular Therapeutics (TCT) annual meeting, Sept. 21–25 in San Diego, Philips is showcasing...
Sponsored Content | Videos | Cath Lab | September 19, 2018
William O’Neill, M.D., outlines his recent clinical publication of AMICS patients from the Impella Quality (IQ) datab
Overlay Init