MedAlliance’s SELUTION SLR Drug-Eluting Balloon Receives Investigational Device Exemption Approval from the FDA

May 27, 2022 – 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). SELUTION SLR was also the first DEB to receive “Breakthrough Device Designation” from the FDA on March 4, 2019, and again on September 25, 2019 for below the knee (BTK) indications in peripheral arterial disease.

“This is a major step for MedAlliance. We have been able to complete the laboratory and preclinical testing required by the FDA and are ready to begin enrolling US patients in a clinical study to support submission for FDA PMA approval. We are thrilled that US patients can also benefit from this breakthrough technology,” commented Jeffrey B. Jump, President and CEO of MedAlliance.

MedAlliance will begin enrollment in the IDE below the knee (BTK) randomized clinical trial (RCT) SELUTION4BTK ( ID: NCT05055297) immediately outside the United States (OUS) and in early summer in US centers. The principal investigators of the study are Drs Ehrin Armstrong (USA), Marianne Brodmann (Austria) and Tjun Tang (Singapore).

SELUTION SLR obtained CE Mark approval for the treatment of peripheral arterial disease in February 2020. The device has shown promising clinical results in the treatment of patients with chronic limb-threatening ischemia (CLTI) and arterial disease below the knee. In the PRESTIGE study which was presented as a late-breaking trial at VIVA 2021 by Dr. Tjun Tang, the use of SELUTION SLR in complex BTK lesions resulted in lasting safety and efficacy results up to at 18 months. An additional 75 patients with BTK disease treated with SELUTION SLR have been studied in the PRISTINE Registry and results are expected to be presented at LINC 2022. Based on promising early data following the use of SELUTION SLR in the treatment of BTK disease, MedAlliance has pursued the design of the SELUTION4BTK ECR to further study the safety and efficacy of this device and to prepare for US FDA approval.

SELUTION SLR’s technology involves unique micro-reservoirs 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 Cell Adherent Technology (CAT™) allows microreservoirs to be applied to 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.

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