MedAlliance’s Selution SLR Drug Eluting Balloon (DEB) has received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration, making it the first DEB limus to be available for US patients, the company said in a press release.
The Selution SLR (sustained limus release) is a new sirolimus eluting balloon that provides controlled and sustained release of drug, similar to a drug eluting stent (DES). The device received FDA Breakthrough Device Designation in March 2019 and later in September 2019 for below the knee (BTK) indications in peripheral arterial disease.
“This is a major milestone for MedAlliance,” the company said in its press release. MedAlliance has announced that it will begin enrollment in the IDE below the knee (BTK) SELUTION4BTK randomized clinical trial (RCT) immediately outside the United States and in early summer at U.S. centers. Principal investigators of the study are Ehrin Armstrong (Adventist Heart and Vascular Institute, Saint Helena, USA), Marianne Brodmann (Graz Medical University, Division of Angiology, Austria) and Tjun Tang (Singapore General Hospital, Singapore ).
Selution SLR obtained CE Mark approval for the treatment of peripheral arterial disease in February 2020. The device has shown promising early clinical results in the treatment of patients with chronic limb threatening ischemia (CLTI) and chronic limb threatening ischemia (CLTI) artery below the knee.
In the PRESTIGE study which was presented as a last minute trial at VIVA 2021 (October 5-7, Las Vegas, USA) by Tang, the use of Selution SLR in complex BTK lesions resulted in results of safety and efficacy lasting up to 18 months. An additional 75 patients with BTK disease treated with Selution SLR have been studied in the PRISTINE Registry and the results are expected to be presented at LINC 2022 (June 6-9, Leipzig, Germany).
Based on early data following the use of Selution SLR in the treatment of BTK disease, MedAlliance has advanced the design of the SELUTION4BTK RCT to further investigate the safety and efficacy of this device and prepare US FDA approval.
Selution SLR’s technology involves unique microreservoirs made from biodegradable polymer blended with the anti-restenotic drug sirolimus. These microreservoirs provide controlled and sustained limus release (SLR) of the drug. Sustained release of sirolimus from stents has been shown to be highly effective in coronary and peripheral vessels.
MedAlliance’s proprietary CAT (Cell Adhesion Technology) allows microreservoirs to be coated onto balloons and adhere to the vessel lumen when delivered via an angioplasty balloon.
Selution SLR is available in Europe and all other countries where the CE mark is recognised.