Concept Medical Inc. Announces FDA Breakthrough Device Designation for MagicTouch SCB Sirolimus-Coated Balloon for Small Coronary Artery Lesions
Concept Medical
Medical Device Developer
FDA
U.S. Food and Drug Administration
Tampa, Florida, December 19, 2020 /PRNewswire/ --Concept Medical Inc.(CMI) was granted “ by the Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA)Breakthrough Device Designation”, awarded for the treatment of small coronary artery lesions in coronary artery disease (CAD)MagicTouch SCBSirolimus-Coated Balloon Catheter.
Recommended indications include "MagicTouch SCBThe sirolimus-coated balloon catheter is indicated for percutaneous transluminal coronary angioplasty following appropriate vessel preparation, and may be used for small coronary artery lesions with a length of 6–36 mm in coronary arteries with a reference vessel diameter of 1.50–2.75 mm.
The three major arteries supplying blood to the cardiac muscle each branch into numerous progressively smaller vessels that ultimately penetrate deep into the myocardial tissue. Obstruction of these small vessels (coronary microvascular disease) reduces blood flow to the heart, leading to chest pain or shortness of breath, as well as diffuse chest discomfort similar to that seen in typical coronary artery disease (CAD), which is often debilitating.
Coronary Microvascular Dysfunction (CMD) is defined as the presence of angina in the absence of significant or any coronary artery disease (CAD) features on angiography. CMD can occur in both men and women, but it is more prevalent in women, particularly after menopause.
Estimates from the Women’s Ischemia Syndrome Evaluation (WISE) study indicate that at least three to four million Americans suffer from ischemia in the absence of obstructive atherosclerosis, accompanied by impaired quality of life, psychological distress, and healthcare costs comparable to those associated with obstructive coronary artery disease (CAD).
Furthermore, microvascular disease is associated with an annual incidence of 2.5% for major adverse cardiovascular events (MACE).
Concept Medical IncPioneered the sirolimus drug delivery platform technology (Nanolutetechnology), with a reliable commercial track record of over 60,000 patient cases in coronary artery applications worldwide.MagicTouch SCBSirolimus-Coated Balloon Uses ThisNanoluteTechnical development for the treatment of small coronary artery lesions in CMD.
"Research on the limus drug delivery platform technology took many years before a design was finally developed."MagicTouch“Such innovative products,” said Dr. Manish Doshi, Founder, President, and Chief Executive Officer, “MagicTouchIt has been commercially used in over 60,000 patients worldwide, with the highest number of patients in Europe, including countries such as Italy, Spain, the Netherlands, and Poland. In addition to commercial sales, we have also received [support/data] from countries such as the United Kingdom, Italy, Brazil, and Japan.MagicTouchclinical and registration data.MagicTouch“It currently holds a significant market share in many European markets. We are now pleased to collaborate with the FDA to make this validated technology—already commercially available in major regulatory markets—available to patients in the United States,” added Manish.
“FDA’sMagicTouch SCBThe designation as a Breakthrough Device will enable CMI to realize its ambition of providing safe, effective, and innovative treatments to patients in the United States. We areMagicTouch SCBConfidence in safety and efficacy stems from positive user feedback, as they have utilized our solutions that have already been implemented and are currently being rolled out across numerous European countries.MagicTouch"commercially available devices," said Dr. Kiran Patel, Chairman of CMI and a cardiologist. He added, "MagicTouch SCB“Selected for the FDA’s Breakthrough Devices Program by virtue of its unique drug delivery technology, it will also enable timely access to clinically validated new technologies for patients in the United States, thereby potentially providing safer and more effective treatment options.”