MedAlliance announced today that it received FDA investigational device exemption (IDE) for its Selution SLR drug-eluting balloon.
Geneva, Switzerland-based MedAlliance designed its Selution SLR (sustained limus release) novel sirolimus-eluting balloon to provide a controlled sustained drug release, similar to a drug-eluting stent.
Selution SLR features unique micro-reservoirs made of biodegradable polymer intermixed with sirolimus. The micro-reservoirs provide a controlled and permanent release of the drug for up to 90 days, while MedAlliance’s CAT (cell-adherent technology) allows microdeposits to coat the balloons and adhere to the vessel lumen when delivered through an angioplasty balloon.
According to a news release, Selution SLR was the first drug-eluting balloon (DEB) to garner FDA breakthrough device designation, first in March 2019, then September 2019, for below-the-knee (BTK) indications in peripheral artery disease (PAD).
The platform currently has CE mark approval for treating PAD and its four total FDA breakthrough device designations cover the treatment of atherosclerotic lesions in innate coronary arteries, coronary in-stent restenosis, peripheral diseases below the knee and indications for arteriovenous fistula.
MedAlliance plans to begin enrollment in its BTK IDE randomized clinical trial, called Selution4BTK, immediately outside the U.S. and early this summer in the U.S.
“This is a major milestone for MedAlliance,” MedAlliance Chair and CEO Jeffrey B. Jump said in the release. “We have been able to successfully complete the bench and pre-clinical testing required by the FDA and are ready to begin enrolling U.S. patients in a clinical study to support submission for FDA PMA approval. We are delighted that U.S. patients may also benefit from this breakthrough technology.”