MedAlliance’s Drug-Eluting Balloon Obtains Another Breakthrough Device Status

The FDA granted MedAlliance’s drug-eluting balloon, Selution SLR, breakthrough device designation for treating atherosclerotic lesions in coronary arteries.

The device, a sustained release drug-eluting balloon catheter, uses “MicroReservoirs” that provide controlled, sustained release of the anti-restenotic drug sirolimus.

The device received previous breakthrough designations for coronary in-stent restenosis, peripheral below-the-knee and AV-Fistula indications.