Country for PR: United Kingdom
Contributor: PR Newswire Europe
Friday, December 18 2020 - 06:20
Small vessels can cause big problems; MagicTouch SCB Granted 'Breakthrough Device Designation' for the treatment of Small Coronary Artery Lesions
TAMPA, Fla., Dec. 18, 2020 /PRNewswire-AsiaNet/ --

    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." 

    Source: Concept Medical