Biotronik commences new trial of Orsiro drug-eluting stent

Biotronik has commenced patient enrolment for a new clinical trial of its Orsiro hybrid drug-eluting stent.

The BIOSTEMI study is the first to directly compare the safety and efficacy of Orsiro with the Xience Xpedition stent in treating ST-segment elevation myocardial infarction (STEMI), a potentially fatal type of heart attack caused by a prolonged obstruction of blood supply.

It represents the largest investigator-initiated study to date evaluating the safety and efficacy of the bioabsorbable polymer stent in comparison to the durable polymer Xience Xpedition device, and aims to build on the findings of previous studies.

The trial is currently in the process of enrolling 1,250 patients at 16 study centres across Switzerland and Italy.

Dr Alexander Uhl, vice-president of marketing for Biotronik's vascular intervention business, said: "Following the extremely promising results seen in the BIOSCIENCE trial’s STEMI subgroup, we intend to prove Orsiro's far-reaching capabilities with a trial focused on this challenging indication."

This comes after the firm last month completed enrolment for BIOFLOW-V, a study examining rates of target lesion failure among patients with coronary artery disease treated with Orsiro.