April 14, 2020
Enrollment Begins in the SAVE Global Study of MedAlliance's Selution SLR for AV Fistula
April 14, 2020—MedAlliance announced enrollment of the first patient in the SAVE study evaluating the use of the Selution SLR sirolimus-eluting balloon for dysfunctional arteriovenous (AV) access treatment indications.
According to the company, the objectives of this prospective, randomized, single-blind multicenter study are to demonstrate the safety and efficacy of the company's Selution SLR device in the treatment of failed AV fistulae in patients undergoing renal dialysis. The study will also qualify for the European Union Medical Device Regulation approval.
The study will randomize 84 patients to treatment with either Selution SLR or plain old balloon angioplasty. To qualify for inclusion the patients must be aged 18–90 years, have a dialysis access that has performed at least one successful dialysis session, and stenosis of > 50% at the outflow vein.
The primary efficacy endpoint of the study will be primary patency of the treated lesion and of the treated circuit at 6 months postintervention. The primary safety endpoint will be freedom from any serious adverse events involving the AV access circuit or the patient at 30 days.
Konstantinos Katsanos, MD, commented in the company's announcement, “We are excited to study this novel sustained release of sirolimus in our dialysis patients with a malfunctioning fistula. We truly look forward to the outcomes.” Dr. Katsanos is Consultant in Interventional Radiology at Patras University in Patras, Greece.
MedAlliance stated that the Selution SLR is designed with microreservoirs made from biodegradable polymer intermixed with sirolimus; the microreservoirs provide controlled, sustained release of the drug.
In January 2020, MedAlliance announced that it has received FDA Breakthrough Device Designation for the Selution SLR sirolimus-eluting balloon catheter for AV fistula indications. Previously, the company received Breakthrough Device designation for the Selution SLR for treating below-the-knee disease and coronary in-stent restenosis.
On February 3, 2020, the company announced CE Mark approval for the Selution SLR sirolimus-eluting balloon for the treatment of peripheral artery disease.