FDA Approves BIOTRONIK’s First Stent in U.S.

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 U.S.
 
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 µm¹ 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 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 is a landmark for BIOTRONIK as it is the company’s first coronary stent to be commercially marketed in the U.S. “We’re proud to make the PRO-Kinetic Energy stent available to physicians and their patients in the U.S,” commented Marlou Janssen, President BIOTRONIK Inc. “It is our intent to expand our portfolio of vascular intervention products, and gaining FDA approval for PRO-Kinetic Energy is a first milestone in that quest.”
 
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¹Sizes up to 3.0 mm