MedAlliance today announced that it has received Investigational Device Exemption (IDE) from the FDA for its Selution SLR drug-eluting balloon.
MedAlliance, based in Geneva, Switzerland, has designed its new sirolimus Selution SLR (sustained limus release) eluting balloon to provide controlled and sustained release of drug, similar to a drug-eluting stent.
Selution SLR features unique micro-reservoirs made of biodegradable polymer blended with sirolimus. The micro-reservoirs provide controlled, sustained drug release for up to 90 days, while MedAlliance’s cell-adherent technology (CAT) allows the micro-deposits to coat the balloons and adhere to the vessel lumen as they are administered through an angioplasty balloon.
According to a press release, Selution SLR was the first drug-eluting balloon (DEB) to earn Breakthrough Device designation from the FDA, first in March 2019 and then in September 2019, for below-the-knee indications ( BTK) in peripheral arterial disease (PAD). ).
The platform currently has CE Mark approval for the treatment of PAD and its four breakthrough device designations by the FDA cover the treatment of atherosclerotic lesions in the innate coronary arteries, in-stent coronary restenosis, devices below the knee and indications of arteriovenous fistula.
MedAlliance plans to begin enrollment in its BTK IDE randomized clinical trial, called Selution4BTK, immediately outside the United States and in early summer in the United States
“This is a major milestone for MedAlliance,” Jeffrey B. Jump, president and CEO of MedAlliance, said in the release. “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 revolutionary technology. »