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 said.
“I was very impressed by the angiographic and IVUS 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. Alexandre Abizaid of São Paulo, Brazil’s Institute Dante Pazzanese de Cardiologia said in a prepared statement.
“It took years of research to master the Limus drug delivery platform technology to devise an innovative product like MagicTouch. MagicTouch has been commercially used in more than 25,000 patients worldwide, with the highest usage in patients in the European region. Besides commercial sales, MagicTouch has been evaluated extensively in clinical studies conducted in countries like the U.K., Italy and Brazil. We are now excited to begin our work with the U.S. FDA in bringing our technology to serve the patients in the USA,” prez & CEO Dr. Manish Doshi said in a prepared release.
“The FDA’s designation of MagicTouch for the Breakthrough Device Program will allow CMI to meet its ambition to provide this promising technology and innovative treatment for ISR patients in the USA. Our confidence in MagicTouch emanates from the positive feedback that we are receiving from the users of our product from current and ongoing commercial sales of MagicTouch in many European countries. CMI is encouraged that the selection of MagicTouch, with its unique drug delivery technology, for the FDA’s Breakthrough Device Program may allow timely access of this promising new technology to the U.S. patients with coronary ISR, with a potential to provide safe and effective treatment,” CMI chairman Dr. Kiran Patel said in a press release.
Last October, Concept Medical said that 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.