Concept Medical said yesterday that it won breakthrough designation from the FDA for its MagicTouch AVF drug-coated balloon.
MagicTouch AVF is designed to treat stenotic lesions of arteriovenous fistulae or arteriovenous graft in hemodialysis treatment of renal failure. India-based Concept Medical’s device is indicated for use in percutaneous transluminal angioplasty.
The PTA procedure, using Concept Medical’s MagicTouch AVF, is intended to open a blocked blood vessel and deliver drugs — in this case, sirolimus — to inhibit the inflammatory pathways.
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