FDA Awards IDE Approval to SELUTION SLR Drug-Eluting Balloon

MedAlliance’s SELUTION SLR drug-eluting balloon (DEB) has received U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) approval, making it the first limus DEB to be available to U.S. patients.

The SELUTION SLR (Sustained Limus Release) is a sirolimus-eluting balloon that provides a controlled sustained drug release, similar to a drug-eluting stent (DES). SELUTION SLR was also the first DEB granted Breakthrough Device Designation by the FDA on March 4, 2019, and further on Sept. 25, 2019, for below-the-knee (BTK) indications in peripheral artery disease.
 
“This is a major milestone for MedAlliance. We have been able to successfully complete the bench and pre-clinical 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 delighted that US patients may also benefit from this Breakthrough Technology,” said Jeffrey B. Jump, MedAlliance chairman and CEO.
 
MedAlliance has begun enrolling patients in the Below-the-knee (BTK) IDE Randomized Clinical Trial (RCT) SELUTION4BTK outside of the United States (OUS) and early this summer in U.S. centers. Principal investigators of the study are Doctors Ehrin Armstrong (U.S.), Marianne Brodmann (Austria), and Tjun Tang (Singapore).
 
SELUTION SLR was awarded CE Mark approval for treating peripheral artery disease in February 2020. The device has shown early promising clinical results in treatment of patients with chronic limb threatening ischemia (CLTI) and below-the-knee artery disease. In the PRESTIGE study which was presented as a late breaking trial at the VIVA 2021 congress by Dr Tjun 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. Based on the early promising 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 FDA approval.
 
SELUTION SLR’s technology involves 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 recognized.