FDA approves Biotronik’s cobalt chromium coronary stent system

The FDA approved the Pro-Kinetic energy cobalt chromium coronary stent system for patients with blockages in their coronary arteries.

Biotronik, which manufactures the stent system, announced the approval on Feb. 16. The company said the Pro-Kinetic energy stent was its first FDA-approved stent.

The stent features a 60 µm strut thickness and 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. It has already been used to treat more than 650,000 patients outside of the U.S., according to Biotronik.

The approval was based on results of the BIOHELIX-1 trial, which enrolled 329 patients at 33 sites in the U.S., Colombia, Germany, Latvia and the Netherlands. The patients had atherosclerotic disease of native coronary arteries and were candidates for PCI and CABG.

After nine months, 9.06 percent of patients had target vessel failure, which was less than half of the researchers’ performance goal of 18.7 percent. All of the patients received the Pro-Kinetic Energy stent.

A previous registry analysis of 1,000 patients with complex lesions found that 8.1 percent of patients had major adverse cardiac events and 4.9 percent had 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,” Saurabh Gupta, MD, the study’s principal investigator, said in a news release. “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.”