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conceptmedical

Concept Medical enrolls first patient in drug-coated balloon study

April 19, 2024 By Sean Whooley

Concept Medical

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 […]

Filed Under: Cardiovascular, Clinical Trials, Drug-Device Combinations, Featured, Vascular Tagged With: conceptmedical

Concept Medical begins enrollment for sirolimus-coated balloon trial

July 29, 2022 By Sean Whooley

Concept Medical

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 […]

Filed Under: Clinical Trials, Drug-Device Combinations, Vascular Tagged With: conceptmedical

Concept Medical wins CE Mark for MagicTouch DCBs

October 18, 2019 By Sean Whooley

Concept Medical

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 […]

Filed Under: Drug-Device Combinations, Featured, Regulatory/Compliance Tagged With: conceptmedical

Concept Medical wins FDA breakthrough nod for MagicTouch AVF drug-coated balloon

August 30, 2019 By Sean Whooley

Concept Medical

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 […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: conceptmedical

FDA grants breakthrough nod to Concept Medical for below-the-knee use of MagicTouch DCB

August 13, 2019 By Nancy Crotti

Concept Medical

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 […]

Filed Under: Uncategorized Tagged With: conceptmedical, FDA

FDA grants breakthrough nod to Concept Medical for MagicTouch DCB

May 2, 2019 By Fink Densford

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 […]

Filed Under: Drug-Device Combinations, Food & Drug Administration (FDA), Regulatory/Compliance, Vascular Tagged With: conceptmedical

Concept Medical raises $60m for sirolimus-coated balloon IDE trial

October 10, 2018 By Fink Densford

Concept Medical

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 […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Wall Street Beat Tagged With: conceptmedical

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