MedAlliance Commences SELUTION4SFA IDE Trial

May 4, 2023—MedAlliance announced the commencement in the United States of the SELUTION4SFA study, which is evaluating the company’s Selution SLR sirolimus drug-eluting balloon (DEB) in the treatment of occlusive disease of the superficial femoral artery and proximal popliteal artery. The study’s first United States patient was enrolled by Arthur Lee, MD, at the Cardiac & Vascular Institute in Gainesville, Florida.

According to the company, the study has been designed to support FDA approval of the Selution SLR. In August 2022, the company announced it received investigational device exemption (IDE) approval to conduct this pivotal trial of the device.

SELUTION4SFA will enroll 300 patients at more than 30 centers in the United States and 10 centers worldwide.

The study will aim to demonstrate the superiority of Selution SLR versus balloon angioplasty. The primary efficacy endpoint is primary patency of the target lesion at 12 months and the primary safety endpoint is freedom from death at 30 days. Enrollment in the study will be completed by the end of 2023, noted the company.

“We are excited to introduce the first sirolimus DEB to United States patients and look forward to a rapid enrollment of this important study,” commented Coprincipal Investigator Jay Mathews, MD, in MedAlliance’s press release. “We hope to learn how this technology can potentially benefit patients with complex peripheral arterial disease.” Dr. Matthews is with Manatee Memorial Hospital in Bradenton, Florida.

In May 2022, the company announced IDE approval for Selution SLR in the treatment of below-the-knee indications. In August 2022, the company announced commencement of enrollment in the SELUTION4BTK trial.

The company has a third ongoing IDE clinical study of the device for coronary in-stent restenosis, SELUTION4ISR. Additionally, in January 2023, the company received conditional approval from the FDA for an IDE to initiate the pivotal SELUTION DeNovo for the Selution SLR device in the treatment of coronary de novo lesions.

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