PR97886

TAMPA, Fla., Sept. 17, 2022 /PRNewswire=KYODO JBN/ --

The US FDA has granted an Investigational Device Exemption (IDE) approval for

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

Coated Balloon (SCB) indicated for In-Stent Restenosis (ISR).

US FDA's IDE approval allows the MagicTouch SCB [

https://www.conceptmedical.com/product/magic-touch/ ] to be used in a pivotal

clinical study to support safety and effectiveness of this combination product.

The data generated from this IDE clinical study will support a pre-market

approval (PMA) application in the USA.

MagicTouch SCB is the world's first Sirolimus-coated Balloon with extensive

commercial usage in Europe, major markets of Asia and the Mid-Eastern markets.

More than 100 thousand patients have been treated with MagicTouch SCB in these

markets.

About MagicTouch SCB:

MagicTouch SCB is a CE marked and commercially marketed Sirolimus coated

balloon developed by Concept Medical [ https://www.conceptmedical.com/ ], using

proprietary Nanolute Technology [

https://www.conceptmedical.com/technology/nanolute/ ]. MagicTouch SCB has been

used in >50,000 patients in major global markets.

About Concept Medical [ https://www.conceptmedical.com/ ] Inc (CMI):

CMI is headquartered in Tampa, Florida and has operational offices in The

Netherlands, Singapore and Brazil and manufacturing units in India. CMI

specializes in developing drug-delivery systems and has unique and patented

technology platforms that can be deployed to deliver any drug / pharmaceutical

agent across the luminal surfaces of blood vessels.

www.conceptmedical.com

Photo - https://mma.prnewswire.com/media/1901255/MagicTouch.jpg

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

Source:  Concept Medical