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