FDA Grants Breakthrough Device Designation for Concept Medical's MagicTouch Sirolimus-Coated Balloon
May 2, 2019—Concept Medical Inc. has been granted Breakthrough Device Designation from the FDA for the company's MagicTouch sirolimus drug-coated balloon (DCB) catheter, for the treatment of coronary in-stent restenosis (ISR).
Under the Breakthrough Devices program, FDA will provide Concept Medical with priority review and interactive communication regarding device development and clinical trial protocols, through to commercialization decisions.
The MagicTouch DCB has received European CE Mark approval and is commercially available in those countries that recognize CE Mark.
Alexandre Abizaid, MD, commented in the company's announcement, "I was very impressed by the angiographic and interventional ultrasound results of MagicTouch in ISR in the Brazil-ISR study. I didn't encounter any safety or toxicity concerns in the course of the trial." Dr. Abizaid is the Chief of Coronary Interventions at Institute Dante Pazzanese de Cardiologia in São Paulo, Brazil.