MedAlliance Completes Enrollment in SAVE Trial of Selution SLR DEB for AVF Treatment

August 14, 2023—MedAlliance announced completion of patient enrollment in the SAVE clinical trial with the Selution SLR 018 drug-eluting balloon (DEB) for the treatment of failed arteriovenous fistulas (AVFs) in renal dialysis patients. Selution SLR is a sustained limus-release sirolimus-eluting balloon.

SAVE is a prospective multicenter, single-blinded, randomized controlled trial evaluating the use of the Selution SLR device for dysfunctional arteriovenous access treatment indications.

According to the company, 84 patients have been randomized to either standard high-pressure balloon angioplasty followed by local application of Selution SLR or high-pressure balloon angioplasty with no further lesion treatment. Study patients were enrolled at three sites in Europe and Singapore and are being followed up to 24 months.

Endpoints of the SAVE study are primary patency at 6 months with angiographic follow-up and freedom from serious adverse events at 30 days. Major secondary endpoints at 6 months are clinical success, freedom from serious adverse events, late lumen loss, and binary vessel restenosis.

The SAVE study’s Principal Investigator is Konstantinos Katsanos, MD, Associate Professor of Interventional Radiology at Patras University Hospital in Patras, Greece.

“We very much look forward to the analysis of the primary endpoint of this important trial at 6 months, as this is the first prospective randomized trial of a sirolimus-coated balloon in AVF patients with angiographic follow-up,” commented Dr. Katsanos in MedAlliance’s press release. “Furthermore, we have also measured fistula volume flow rates, which is another key index of failing or maintained fistula function. I thank MedAlliance for initiating a trial in this difficult patient population.”

Selution SLR received CE Mark approval for the treatment of peripheral artery disease in January 2020 and the treatment of coronary artery disease in May 2020. It 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.