Update: This story has been corrected to reflect the source of 12-month data for the PRO-Kinetic device. It comes from the previous ENERGY Registry study, and not from the BIOHELIX-1 study.
Biotronik has received FDA approval for a bare-metal stent designed to treat coronary artery disease. It is the company’s first coronary stent to hit the U.S. market.
The PRO-Kinetic Energy Cobalt Chromium Coronary Stent System is intended for patients with new and recurring blockages in the coronary arteries between 2.25 and 4.0 mm in diameter, according to a statement. It may treat lesions up to 31 mm long.
Made of a cobalt-chromium alloy, the stent has “ultrathin” struts and a double-helix design, allowing flexibility and facilitating delivery in challenging vessels, the company said. It is coated in a silicon-carbide layer, which cuts down on metal ion release from the device to the surrounding tissue.
The approval is based on the BIOHELIX-1 study, which enrolled 329 patients at 33 sites around the world. Nine months postprocedure, the study showed a target vessel failure rate of 9%, beating its performance goal of 18.7%, the company said.
The ENERGY Registry study, which involved more than 1,000 patients with complex lesions, posted a major adverse cardiac event rate of 8%, with a 4.9% rate in target lesion revascularization at the 12-month mark.
"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, M.D., principal investigator for the pivotal U.S. trial, said in the statement. "It's a new generation bare-metal stent with an innovative design and biocompatible coating that has superb deliverability."
A cardio- and endovascular specialist, Biotronik scored a CE mark for Magmaris—the first clinically proven bioresorbable magnesium scaffold for coronary artery disease—last summer. And in late 2015, the company earned FDA approval for its Astron stent to treat peripheral artery disease.