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TAMPA, Fla., Dec. 18, 2020 /PRNewswire/ -- Concept Medical Inc. (CMI) has been granted "Breakthrough Device Designation" from the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) for the MagicTouch SCB Sirolimus Coated Balloon Catheter, for the treatment of small coronary artery lesions in Coronary Artery Disease (CAD).
The proposed indication for use includes "The MagicTouch SCB Sirolimus Coated Balloon Catheter is indicated for percutaneous transluminal coronary angioplasty, after appropriate vessel preparation, of small coronary artery lesion lengths of 6 - 36mm in coronary arteries with reference vessel diameters of 1.50 - 2.75mm."
Each of the three main arteries supplying blood to the cardiac musculature, branches into progressively smaller vessels that eventually penetrate the cardiac musculature. Occlusion of these small vessels (coronary microvascular disease) can diminish blood flow to the heart leading to chest pain or shortness of breath, as well as diffuse chest discomfort similar (and often as debilitating) to those from classic Coronary Artery Disease (CAD).
This presence of angina with minimal or no angiographic CAD is referred to as Coronary Microvascular Dysfunction (CMD). CMD can occur in both sexes, but is more prevalent in women, especially after menopause.
Estimates from the Women's Ischemia Syndrome Evaluation (WISE) study show that there are at least three to four million Americans with ischemia despite the absence of obstructive atherosclerosis, with associated poor quality of life, psychological distress, and health-care costs that approximate those with obstructive CAD.
Furthermore, microvascular disease is associated with a 2.5% annual major adverse cardiovascular event (MACE) rate.
Concept Medical Inc has pioneered the Sirolimus drug delivery platform technology (Nanolute Technology) which has a proven commercial history in coronary applications in more than 60,000 patients worldwide. MagicTouch SCB Sirolimus coated balloon is developed using this Nanolute Technology for use in the treatment of small coronary artery lesions in CMD.
"It took years of research to master the Limus drug delivery platform technology to devise an innovative product like MagicTouch," said the Founder, President and CEO, Dr. Manish Doshi. "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 registries data of MagicTouch from countries like 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 USA," Manish added.
"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," said cardiologist Dr. Kiran Patel, Chairman of CMI. He also added, "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."
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