Concept Medical this week said it received breakthrough device designation for its MagicTouch SCB sirolimus coated balloon catheter.
The catheter is designed to treat small coronary artery lesions in coronary artery disease. The breakthrough device designation is indicated for percutaneous transluminal coronary angioplasty of small coronary artery lesion lengths of 6-36mm in coronary arteries with reference vessel diameters of 1.5-2.75mm.
“It took years of research to master the Limus drug delivery platform technology to devise an innovative product like MagicTouch,” founder, president and CEO Manish Doshi said in a news release. “MagicTouch has been commercially used in >60,000 patients worldwide, with the highest usage in patients in the European region including Italy, Spain, The Netherlands, Poland and others. Besides commercial sales, we also have clinical and registry data of MagicTouch from countries like the UK, Italy, Brazil and Japan. MagicTouch is now enjoying a significant market share in many European markets. We are now excited to work with the FDA in bringing the proven technology (with commercial sales in major regulated markets) to serve the patients in the U.S..”
Occlusion of the small vessels in the cardiac musculature can reduce blood flow to the heart, which can lead to chest pain or shortness of breath, as well as diffuse chest discomfort similar to coronary artery disease.
“The FDA’s designation of MagicTouch SCB for the Breakthrough Device Program will allow CMI to meet its ambition to provide safe, effective and innovative treatment for patients in the US. Our confidence in the safety and efficacy of MagicTouch SCB emanates from the positive feedback that we are receiving from the users of our Device from current and ongoing commercial sales of MagicTouch in many European countries,” cardiologist and chairperson Kiran Patel said. “The selection of MagicTouch SCB, with its unique drug delivery technology, for the FDA’s Breakthrough Device Program will also allow timely access to new technologies, that are clinically proven, to the US patients with a potential to provide safer and effective treatment.”