Medical technology company MedAlliance revealed on Monday that it has admitted the first patient under its SELUTION SLR 014 DEB study for the treatment of in-stent restenosis (ISR) and the study is expected to support the submission of an US FDA approval process.

The company added that the SELUTION SLR (Sustained Limus Release) is a novel sirolimus-delivering balloon with controlled sustainable Delivery of a drug, similar to a drug-eluting stent (DES). The study director is Donald Cutlip, professor of medicine at Harvard Medical School and chief medical officer at the Baim Institute for Clinical Research.

According to the company, the SELUTION SLR are made from a mixture of biodegradable polymer and the anti-restenotic active ingredient sirolimus. These micro reservoirs enable the controlled and sustainable release of the active ingredient (Sustained Limus Release, SLR). Delayed sirolimus delivery from stents has proven to be highly effective for coronary and peripheral vascular systems.

This prospective, randomized, multicenter, single-blind study is intended to demonstrate the safety and efficacy of the company's SELUTION SLR for the treatment of ISR with drug-delivering stents or pure metal stents.

Up to 418 participants are recruited in 60 study centres in the US and Europe. The primary efficacy endpoint is target lesion failure (TLF), which is defined as cardiac death, target vessel myocardial infarction, or clinically indicated target lesion revascularization (TLR) after 12 months. Participants are examined after the first, sixth, and twelve months and then once a year for five years, concluded the company.