PR87329

TAMPA, Fla., Dec. 18, 2020 /PRNewswire=KYODO JBN/ --

    Concept Medical Inc. [https://www.conceptmedical.com/] (CMI) has been granted

"Breakthrough Device Designation" [https://www.conceptmedical.com/press-release/magictouch-scb-granted-breakthrough-device-designation/ ] from the Center for Devices and Radiological

Health (CDRH) of the Food and Drug Administration (FDA) for the MagicTouch SCB

[https://www.conceptmedical.com/product/magic-touch/] 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

[https://www.conceptmedical.com/product/magic-touch/] 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 [https://www.conceptmedical.com/] 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 [https://www.conceptmedical.com/technology/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."

    www.conceptmedical.com

    Logo: https://mma.prnewswire.com/media/1244676/Concept_Medical_Logo.jpg

    Photo: https://mma.prnewswire.com/media/1388274/MagicTouch_SCB.jpg

    Source: Concept Medical