FDA Approval Granted for BIOTRONIK's Ultra-Thin PRO-Kinetic Energy Cobalt Chromium Coronary Stent System

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Feb 15, 2017, 09:42 ET

LAKE OSWEGO, Ore. and BUELACH, Switzerland, Feb. 15, 2017 /PRNewswire/ -- 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."

More information on the BIOHELIX-I clinical study is available at www.ClinicalTrials.gov (identifier: NCT01612767).

About PRO-Kinetic Energy Cobalt Chromium (CoCr)
Coronary Stent System
The PRO-Kinetic Energy Cobalt Chromium Bare-Metal Stent features ultra-thin struts of only 60 µm* and a unique double-helix design, resulting in exceptional flexibility and deliverability even in challenging vessels. The stent is made from a cobalt chromium alloy and is coated with proBIO, a silicon carbide layer that reduces metal ion release from the stent surface into the surrounding tissue. PRO-Kinetic Energy Cobalt Chromium Bare-Metal Stent platform also forms the basis of the Orsiro** Hybrid Drug-Eluting Stent and the PK Papyrus*** stent system for treating acute coronary
artery perforation.

About BIOTRONIK
A global leader in cardio-and endovascular medical technology, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries. Several million patients have received BIOTRONIK implants designed to save and improve the quality of their lives, or have been treated with BIOTRONIK coronary and peripheral vascular intervention products. Since its development of the first German pacemaker in 1963, BIOTRONIK has engineered many innovations, including Magmaris***, the first clinically-proven resorbable magnesium scaffold; BIOTRONIK Home Monitoring^®; Pulsar**, the world's first 4 F compatible stent for treating long lesions; Orsiro**, the industry's first hybrid drug-eluting stent; and the world's first implantable cardioverter defibrillators and heart failure therapy devices with ProMRI^® technology.

^* Sizes up to 3.0 mm
^** CAUTION – Investigational device. Limited by United States law to investigational use.
^*** Not currently available in the United States.

For more information, visit: www.biotronikusa.com
Twitter: @BIOTRONIK_US
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LinkedIn: www.linkedin.com/company/biotronik

SOURCE BIOTRONIK