February 3, 2020
MedAlliance’s Selution SLR Receives CE Mark Approval
February 3, 2020—MedAlliance announced CE Mark approval for the Selution SLR sirolimus-eluting balloon for the treatment of peripheral artery disease. This approval applies to sizes from 2 X 20 mm to 7 X 150 mm.
Approval was supported by 2-year results from the SELUTION SLR first-in-human study, which was composed of 50 patients enrolled at four German centers. The data were presented by Professor Thomas Zeller, MD, the study’s Principal Investigator, at VIVA 2019, the Vascular InterVentional Advances meeting held November 4–7 in Las Vegas, Nevada.
According to MedAlliance, the Selution SLR device has 6-month clinical follow-up that demonstrated 2.3% target lesion revascularization (TLR) and late lumen loss of 0.19 mm. The 2-year clinical results confirmed no deaths or amputations. Patients demonstrated clinical improvement as measured by Rutherford classification, ankle-brachial index, and walking distance at 6 months and 1 year, which was maintained out to 2 years. These data demonstrate that a sustained limus-release eluting balloon is safe and effective for the treatment of femoropopliteal lesions over a prolonged period, stated the company.
The first-in-human study also achieved freedom from TLR through 2 years in 87.5% of patients, with no primary TLR event observed after month 11. These figures are low compared with reported historical first-in-human studies, noted the company.
MedAlliance recently announced completion of its PRESTIGE below-the-knee first-in-human study in Singapore. Additionally, studies in arteriovenous fistula and pedal arch will start enrolling soon, and a 500-patient postmarket clinical study will follow shortly.
The Selution SLR’s technology involves microreservoirs made from biodegradable polymer intermixed with the antirestenotic drug sirolimus. These microreservoirs provide controlled and sustained release of the drug. MedAlliance’s CAT cell adherent technology enables the microreservoirs to be coated onto balloons and adhered to the vessel lumen when delivered via an angioplasty balloon, stated the company.