MedAlliance’s SELUTION4BTK IDE Trial Begins Enrollment

June 8, 2022—MedAlliance announced that the first patient has been enrolled in the SELUTION4BTK trial.

SELUTION4BTK is a prospective, multicenter, single-blinded, randomized controlled trial evaluating the safety and efficacy of the company’s Selution SLR sirolimus-eluting balloon in below-the-knee (BTK) peripheral artery disease. Drs. Ehrin Armstrong, Marianne Brodmann, and Tjun Tang are its principal investigators.

On May 27, the company announced FDA approval of an investigational device exemption for the trial. The BTK indication for Selution SLR was granted Breakthrough Device designation by the FDA in 2019.

According to the company, the aim of the SELUTION4BTK clinical trial is to demonstrate the superior efficacy and equivalent safety of the Selution SLR compared to plain balloon angioplasty in the treatment of BTK arteries in patients with chronic limb-threatening ischemia (CLTI).

In the trial, 377 patients are being randomized 1:1 to either Selution SLR or the control. Patients are being enrolled at approximately 40 sites across the United States, Europe, and Asia. The study will be able to include real-world patients with critical limb ischemia, noted the company.

“I am excited to begin an important trial which will establish the evidence that this novel technology benefits patients suffering from CLTI,” commented Michael Lichtenberg, MD, in the company’s press release. Dr. Lichtenberg, who is Chief of the Angiology Department at the Klinikum Hochsauerland in Arnsberg, Germany, continued, “So far, nothing has worked consistently in this patient population. The early clinical data from Selution SLR registries are encouraging and I have seen the performance of this new technology in my routine work. This study is designed to prove that Selution SLR is more effective than the current standard of care in this difficult patient population.”

The company noted Selution SLR is available in Europe and all countries where the CE Mark is recognized. Selution SLR was awarded European CE Mark approval for the treatment of peripheral artery disease in February 2020 and for the treatment of coronary artery disease in May 2020.

In the United States, the FDA has awarded Selution SLR four breakthrough designations: for the treatment of atherosclerotic lesions in native coronary arteries; coronary in-stent restenosis; peripheral BTK; and arteriovenous fistula indications.