MagicTouch PTA – BIBA Medtech Insights

MagicTouch becomes first sirolimus-coated balloon for peripheral arteries to receive the CE mark

MagicTouch AVF Concept Medical BV has received the CE mark for its range of MagicTouch drug-coated balloons. The balloons are indicated for peripheral arterial disease, erectile dysfunction, arteriovenous fistula and arteriovenous graft. The CE mark approvals mean that the MagicTouch percutaneous transluminal angioplasty (PTA) catheter is the only commercially available, CE-mark certified, [...]

FDA Breakthrough Device Designation for sirolimus-coated MagicTouch peripheral balloon

Concept Medical has been granted Breakthrough Device Designation from the FDA for its MagicTouch percutaneous transluminal angioplasty (PTA) device—a sirolimus drug-coated balloon catheter—for the treatment of below-the-knee lesions. Earlier this year, on 30 April 2019, Concept Medical received its first Breakthrough Device for its MagicTouch coronary balloon for the treatment of Coronary Artery Disease [...]