MedAlliance announced today that its novel sirolimus-eluting balloon received conditional FDA investigational device exemption (IDE).
Geneva, Switzerland-based MedAlliance can now initiate its pivotal clinical trial for the treatment of coronary de novo lesions.
MedAlliance received its first IDE for Selution SLR in below-the-knee indications in May 2022. It picked up a second IDE in August. Those regulatory nods cover occlusive disease of the superficial femoral artery (SFA) and coronary in-stent restenosis (ISR).
The company expects to enroll in its Selution SLR coronary de novo study in the U.S. within the next few months. That trial will complement its European de novo study of more than 800 patients (3,326 planned). The trial evaluates Selution SLR against any sirolimus drug-eluting stent (DES), attempting to demonstrate the superiority of the balloon over the stent in treating coronary de novo artery disease.
“Coronary de novo lesions are the largest potential opportunity for use of [drug-eluting balloons]: the data has shown clearly that DES don’t work well in small vessels, long, or bifurcated lesions or in patients with diabetes or risk of high bleeding complications,” said MedAlliance Chair and CEO Jeffrey Jump. “These patients represent 60% of all patients currently treated with DES, who may now benefit from this exciting new DEB technology.”
About the MedAlliance Selution SLR drug-eluting balloon
Selution SLR provides a controlled sustained drug release, similar to a drug-eluting stent. It 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. MedAlliance’s CAT (cell-adherent technology) allows microdeposits to coat the balloons and adhere to the vessel lumen when delivered through an angioplasty balloon.
The system received CE mark approval for treating peripheral artery disease (PAD) in 2020. CE mark for treating coronary artery disease followed in May 2020.
MedAlliance says Selution SLR was the first drug-eluting balloon (DEB) to garner FDA breakthrough device designation. The first came in March 2019, followed by September 2019, for below-the-knee indications in PAD.
It holds four total FDA breakthrough device designations. They cover the treatment of atherosclerotic lesions in innate coronary arteries, coronary in-stent restenosis, peripheral diseases below the knee and indications for arteriovenous fistula.