MedAlliance’s SELUTION DeNovo Study Enrolls First of 3,300 Patients to Compare Sirolimus DEB Versus DES

August 31, 2021—MedAlliance announced the enrollment of the first patient in the coronary randomized controlled SELUTION DeNovo study of the company’s Selution SLR sirolimus drug-eluting balloon (DEB) versus a limus drug-eluting stent (DES).

According to the company, the study will enroll more than 3,300 patients at approximately 50 sites in 15 countries. Patients will be randomized before any vessel preparation to reflect current medical practice and to reduce bias. The objectives of the study are to demonstrate noninferiority at 1 and 5 years and subsequently to show superiority for target vessel failure.

This study aims to influence a change in medical practice because the majority of de novo coronary vessels are currently treated with a permanent metallic stent. The Selution SLR elutes sirolimus for more than 90 days, similar to a DES, but without leaving behind a metal scaffold, which has been associated with a complication rate of 2% annually, stated MedAlliance.

Juan F. Iglesias, MD, from Geneva University Hospitals in Geneva, Switzerland serves as Principal Investigator of the study.

“We are pleased to participate in a robust prospective, randomized study, working with some of the leading institutions and operators in the world to answer these important questions for patients and physicians alike,” commented Dr. Iglesias in MedAlliance’s press release. “We are excited to be the first enrolling center in this important study. Initial use of this novel DEB has demonstrated a high level of deliverability, especially in small vessels and side branches.”

The company advised that the MedAlliance Selution SLR was awarded European CE Mark approval for the treatment coronary arterial disease in May 2020. The device previously gained CE Mark approval for treating peripheral artery disease in February 2020.

In the United States, the FDA has awarded the Selution SLR with four breakthrough designations for coronaries, peripheral vascular, and arteriovenous fistula indications.