Small vessels can cause big problems; MagicTouch SCB Receives Breakthrough Device Designation for Treatment of Small Coronary Artery Lesions

Tampa, Fla. (ots/PRNewswire) – Concept Medical Inc. (CMI) hat vom Center for Devices and Radiological Health (CDRH) der US-amerikanischen Food and Drug Administration (FDA) die “Breakthrough Device Designation” for the MagicTouch SCB Sirolimus-coated balloon catheter for the treatment of small coronary artery lesions in coronary artery disease (CAD).

The suggested indication is: “The MagicTouch SCB Sirolimus-coated balloon catheter is indicated for percutaneous transluminal coronary angioplasty, after appropriate vessel preparation, of small coronary artery lesions 6 – 36 mm in length in coronary arteries with reference vessel diameters of 1.50 – 2.75 mm. “

The three main arteries that supply the heart muscles with blood branch out into smaller and smaller vessels that eventually penetrate the heart muscles. Occlusion of these small vessels (coronary microvascular disease) can weaken the blood flow to the heart, which is noticeable in chest pain or shortness of breath, as well as diffuse chest discomfort that resembles those of classic coronary artery disease (CHD) (and often the patients affect just as much).

The occurrence of angina pectoris with minimal or no angiographic CAD is known as coronary microvascular dysfunction (CMD). CMD can occur in either sex, but is more common 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 American women with ischemia who do not have obstructive atherosclerosis. Their reduced quality of life, the psychological suffering and the resulting costs for the health system are the same as those of obstructive CHD.

In addition, microvascular disease is associated with an annual rate of 2.5% major cardiovascular events (MACE).

Concept Medical Inc has with the Sirolimus drug delivery platform technology (Nanolute Technology) pioneered work that has proven itself in practice in coronary applications on more than 60,000 patients worldwide. MagicTouch SCB Sirolimus-coated balloon comes with this Nanolute Technology developed for the treatment of small coronary artery lesions in CMD.

“It took many years of research to master the Limus drug delivery platform technology and an innovative product like MagicTouch to develop, “said the founder, president and CEO, Dr. Manish Doshi.”MagicTouch“Has been used commercially on more than 60,000 patients worldwide, particularly patients in Europe including Italy, Spain, the Netherlands, Poland and others. In addition to commercial sales, we also have clinical and approval data for MagicTouch from countries like the UK, Italy, Brazil and Japan. MagicTouch now has a significant market share in many European markets. We are excited to now work with the FDA to bring the proven technology (already sold in other major regulated markets) to patients in the United States, “added Manish.

“The FDA Approval of MagicTouch SCB for the Breakthrough Device Program will enable CMI to achieve its goal of providing safe, effective and innovative treatments for patients in the United States. The positive feedback we received from the users of our device MagicTouch SCB Received from current and ongoing commercial sales in many European countries makes us confident in the safety and effectiveness of MagicTouch“said cardiologist Dr. Kiran Patel, chairman of CMI. He added,” By choosing MagicTouch SCBWith its unique drug delivery technology for the FDA’s Breakthrough Device Program, we may soon bring these clinically proven technologies to US patients because they have strong, safer and more potential to provide more effective treatment. “

www.conceptmedical.com

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