Concept Medical announced today that it commenced the FDA investigational device exemption (IDE) study of its MagicTouch system. MagicTouch, a sirolimus drug-coated balloon (DCB), treats in-stent restenosis (ISR) in coronary artery disease (CAD). Dr. Said Ashraf enrolled the first patient in the MAGICAL-ISR study at the AtlantiCare Institute in Atlantic City, New Jersey. The balloon […]
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Concept Medical begins enrollment for sirolimus-coated balloon trial
Concept Medical announced today that it has already enrolled 15 patients in a trial of its drug-coated balloon (DCB) for peripheral artery disease (PAD). Tampa, Florida-based Concept Medical’s LIMES prospective multi-center randomized controlled trial to evaluate the safety and efficacy of below-the-knee (BTK) sirolimus drug-coated balloon against standard angioplasty for the treatment of infrapopliteal occlusions […]
Concept Medical wins CE Mark for MagicTouch DCBs
Concept Medical said yesterday that it received CE Mark approval for three versions of its MagicTouch sirolimus-coated balloons. The MagicTouch PTA for peripheral artery disease, MagicTouch ED for erectile dysfunction and MagicTouch AVF for arterio-venous fistula and graft all received approval in Europe, according to a news release. Concept Medical said MagicTouch PTA is the […]
Concept Medical wins FDA breakthrough nod for MagicTouch AVF drug-coated balloon
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 […]
FDA grants breakthrough nod to Concept Medical for below-the-knee use of MagicTouch DCB
Medtech developer Concept Medical said today it won FDA breakthrough device designation for below-the-knee (BTK) use of its MagicTouch sirolimus drug-coated balloon catheter designed for the treatment of peripheral artery disease. The Tampa, Fla.-based company won the same designation for MagicTouch for the treatment of coronary in-stent restenosis in April. The XTOSI clinical study at Sengkang […]
FDA grants breakthrough nod to Concept Medical for MagicTouch DCB
Medtech developer Concept Medical said today it won FDA breakthrough device designation for its MagicTouch sirolimus drug-coated balloon catheter designed for the treatment of coronary in-stent restenosis. The device is cleared for treating patient’s who’ve experienced a re-narrowing of a stented coronary artery lesion due to subsequent tissue proliferation at the stented site, the Tampa, Fla.-based company […]
Concept Medical raises $60m for sirolimus-coated balloon IDE trial
Medtech developer Concept Medical said yesterday it received $60 million from cardiologist and serial entrepreneur Dr. Kiran Patel to support pursuit of an FDA investigational device exemption trial for its sirolimus-coated balloon device. The Florida-based company touted the device as the world’s first sirolimus-coated balloon, and said that funds will also be used to support […]
