Biotronik said today it won FDA approval for its Pro-Kinetic Energy cobalt chromium coronary stent system, with indication for use in patients with arterial blockages between 2.25 and 4mm in diameter and lesion length up to 31 mm.
The Pro-Kinetic Energy stent system is designed to imProve coronary luminal diameter in patients with new or recurring blockages in the coronary arteries. The Berlin, Germany-based company said FDA apProval of the device based off of results from its Biohelix-I clinical study.
“We’re proud to make the Pro-Kinetic Energy stent available to physicians and their patients in the US. 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,” prez Marlou Janssen said in a prepared statement.
Data from the company’s 329-patient Biohelix-1 trial reported a 9.1% rate of target vessel failure at 9 months, much lower than its performance goal of 18.7%. Biotronik said the clearance made the Pro-Kinetic Energy stent system the company’s 1st coronary stent commercially available in the US.
“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. 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,” trial principal investigator Dr. Saurabh Gupta said in a press release.
Earlier this month, the FDA released a warning letter it sent to Biotronik over issues it identified during an inspection of its facilities in Berlin, shortly after the company announced the launch of its Ilivia cardiac resynchronization therapy devices.
In the letter, the federal watchdog referenced 6 specific violations and warned that “given the serious nature of the violations” that the agency was “taking steps to refuse entry of the devices into the United States.”
A Biotronik spokeswoman told MassDevice.com via email that the company responded to the FDA before the deadline and received an “all clear” letter Nov. 22, 2016. “Biotronik expects a formal close-out by the FDA shortly,” she wrote.