Biotronik has secured the US Food and Drug Administration (FDA) approval for its PRO-kinetic energy cobalt chromium (CoCr) coronary stent system, based on the results from the BIOHELIX-I clinical study.
Designed to increase coronary luminal diameter in patients with new and reoccurring blockages in the coronary arteries, the bare-metal stent has already been used to treat more than 650,000 patients.
Indicated for patients with arterial vessels blockage of 2.25mm to 4.0mm in diameter and lesion lengths up to 31mm, the thin and 60µm thickness of the cobalt-chromium stent is claimed to facilitate optimal deliverability under the conditions such as tortuosity and calcification.
The prospective, non-randomised, multi-centre BIOHELIX–I trial evaluated the stent's safety and efficacy in 329 patients across 33 sites.
Results from the trial were found to be consistent with the positive results from other PRO-kinetic energy trials such as Energy Registry study in more than 1,000 patients.
US trial principal investigator Saurabh Gupta said: "The BIOHELIX-I study results show that the PRO-Kinetic Energy stent is a great choice for safely treating coronary artery disease and minimising 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."
The stent features a double-helix design that enables flexibility and deliverability, while the silicon carbide layer coating called proBIO, minimises the metal ion release from the stent surface into the surrounding tissue.
Image: The PRO-Kinetic Energy Cobalt Chromium Bare-Metal Stent. Photo: courtesy of Biotronik.