FDA grants IDE approval for Selution SLR drug-eluting balloon

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MedAlliance SELUTION SLR
Selution SLR

MedAlliance’s Selution SLR drug-eluting balloon (DEB) has received investigational device exemption (IDE) approval from the US Food and Drug Administration, making it the first limus DEB to be available to US patients, the company announced in a press release.

The Selution SLR (sustained limus release) is a novel sirolimus-eluting balloon that provides a controlled sustained drug release, similar to a drug-eluting stent (DES). The device was granted breakthrough device designation by the FDA in March 2019 and further in September 2019 for below-the-knee (BTK) indications in peripheral artery disease.

“This is a major milestone for MedAlliance,” the company states in its press release. MedAlliance has announced it will begin enrolment in the below-the-knee (BTK) IDE randomised clinical trial (RCT) SELUTION4BTK immediately outside of the US and early this summer in US centres. Principal investigators of the study are Ehrin Armstrong (Adventist Heart and Vascular Institute, St Helena, USA), Marianne Brodmann (Medical University of Graz, Division of Angiology, Austria), and Tjun Tang (Singapore General Hospital, Singapore).

Selution SLR was awarded CE mark approval for the treatment of peripheral artery disease in February 2020. The device has shown early promising clinical results in treatment of patients with chronic limb threating ischemia (CLTI) and below-the-knee artery disease.

In the PRESTIGE study which was presented as a late breaking trial at VIVA 2021 (5–7 October, Las Vegas, USA) by Tang, use of Selution SLR in complex BTK lesions resulted in sustained safety and efficacy outcomes out to 18 months. An additional 75 patients with BTK disease and Selution SLR treatment have been studied in the PRISTINE registry and the results are scheduled to be presented at LINC 2022 (6–9 June, Leipzig, Germany).

Based on the early data following the use of Selution SLR in treatment of BTK disease, MedAlliance has moved forward with the design of the SELUTION4BTK RCT to further investigate the safety and efficacy of this device and prepare for US FDA approval.

Selution SLR’s technology involves unique MicroReservoirs made from biodegradable polymer intermixed with the anti-restenotic drug sirolimus. These MicroReservoirs provide controlled and sustained limus release (SLR) of the drug. Extended release of sirolimus from stents has been demonstrated highly efficacious in both coronary and peripheral vasculatures.

MedAlliance’s proprietary CAT (cell adherent technology) enables the MicroReservoirs to be coated onto balloons and adhered 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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