Concept Medical’s MagicTouch Sirolimus-Coated Devices Gain CE Mark Approval
October 18, 2019—Concept Medical has announced European CE Mark approval for its MagicTouch line of sirolimus-coated devices. These include the MagicTouch PTA, a sirolimus-coated percutaneous transluminal angioplasty (PTA) balloon catheter to treat peripheral artery disease (PAD); MagicTouch AVF, a sirolimus-coated PTA balloon catheter for treating complications from arteriovenous fistula and arteriovenous grafts; and MagicTouch ED, a sirolimus-coated balloon catheter for erectile dysfunction. The company will commercialize these products across Europe and in other markets that recognize CE Mark certification.
On August 29, Concept Medical announced that it had received FDA Breakthrough Device designation for the MagicTouch AVF device. On August 13, the company announced FDA Breakthrough Device designation for the MagicTouch PTA balloon catheter for the treatment of PAD below the knee.