MedAlliance Set to Begin SELUTION4BTK Randomized Trial of Its Selution SLR Sirolimus-Eluting Balloon

May 27, 2022—MedAlliance has announced receipt of FDA investigational device exemption (IDE) approval and its plans to begin enrollment in SELUTION4BTK, a randomized controlled trial evaluating the safety and efficacy of the company's Selution SLR sirolimus-eluting balloon in below-the-knee (BTK) peripheral artery disease. Drs. Ehrin Armstrong, Marianne Brodmann, and Tjun Tang are its principal investigators.

The company expects enrollment to commence immediately outside of the United States and early this summer in United States centers. The trial follows earlier experiences in the PRESTIGE study and the PRISTINE registry, and data are set to be presented at LINC 2022, to be held June 6-9 in Leipzig, Germany.

“This is a major milestone for MedAlliance,” said Jeffrey B. Jump, MedAlliance Chairman and CEO, in the company's announcement. “We have been able to successfully complete the bench 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 delighted that US patients may also benefit from this Breakthrough Technology.”

The Selution SLR platform previously received FDA Breakthrough Device designation status in September 2019 to treat BTK peripheral artery disease. In February 2020, the device received CE Mark approval in European countries.

According to the company, the Selution SLR technology involves microreservoirs made from biodegradable polymer intermixed with sirolimus that provide the controlled sustained release of the drug; MedAlliance’s Cell Adherent Technology enables the microreservoirs to be coated onto balloons and adhered to the vessel lumen when delivered via an angioplasty balloon.