MedAlliance Receives IDE Approval for Coronary Trial of Selution SLR to Treat In-Stent Restenosis

October 24, 2022—MedAlliance announced that it has received approval of an FDA investigational device exemption (IDE) to initiate its coronary pivotal clinical trial of the Selution SLR sirolimus drug-eluting balloon (DEB) with sustained limus release (SLR) to treat in-stent restenosis (ISR). The study has already begun enrollment in Europe.

Enrollment of the IDE SELUTION4ISR coronary study is ongoing in Europe and will start in the United States later in 2022. The trial will be conducted at up to 60 centers worldwide and in up to 40 centers in the United States. The study is powered to demonstrate noninferiority versus standard of care (80% versus drug-eluting stent [DES] and 20% versus plain old balloon angioplasty) and is currently 10% enrolled.

Don Cutlip, MD, who is Chief Medical Officer at Baim Institute for Clinical Research in Boston, Massachusetts, serves as Principal Investigator of the IDE SELUTION4ISR study.

Dr. Cutlip commented in the company’s press release, “We are pleased with the speed of European enrollment and look forward to enrolling the first United States patient before the year end. United States site selections are underway and will be finalized over the next several weeks. This study has the potential to address the important unmet need of a non-stent treatment for the ongoing problem of in-stent restenosis.”

In the coming weeks, MedAlliance plans to submit its fourth IDE application, this one for de novo coronary artery lesions. The company noted that more than 540 of the 3,326 patients planned have been enrolled in this coronary randomized controlled study comparing Selution SLR versus any limus DES. That study is powered to demonstrate the superiority of the Selution SLR DEB over DES for coronary de novo artery disease.

FDA granted Breakthrough Device designation for the Selution SLR in below-the-knee and superficial femoral artery indications, for which the company received FDA IDE approval in May and August 2022.

Selution SLR was awarded CE Mark approval for the treatment of peripheral artery disease in February 2020 and for the treatment of coronary artery disease in May 2020. It is commercially available in Europe, Asia, the Middle East, the Americas (outside of the United States), and most other countries where the CE Mark is recognized.

On October 18, MedAlliance and Cordis announced that Cordis will be acquiring MedAlliance. The transaction is subject to customary closing conditions, including regulatory approval.