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.

 

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Cardiac Interventions Today (ISSN 2572-5955 print and ISSN 2572-5963 online) is a publication dedicated to providing comprehensive coverage of the latest developments in technology, techniques, clinical studies, and regulatory and reimbursement issues in the field of coronary and cardiac interventions. Cardiac Interventions Today premiered in March 2007 and each edition contains a variety of topics in a flexible format, including articles covering various perspectives on current clinical topics, in-depth interviews with expert physicians, overviews of available technologies, industry news, and insights into the issues affecting today's interventional cardiology practices.