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.
