MagicTouch SCB receives IDE approval for In-Stent Restenosis indication – Canada NewsWire

Searching for your content…
877-269-7890 from 8 AM – 10 PM ET
Contact Cision
from 8 AM – 10 PM ET
News provided by
Sep 17, 2022, 16:30 ET
Share this article
TAMPA, Fla., Sept. 17, 2022 /CNW/ — The US FDA has granted an Investigational Device Exemption (IDE) approval for MagicTouch Sirolimus Coated Balloon (SCB) indicated for In-Stent Restenosis (ISR).
US FDA’s IDE approval allows the MagicTouch SCB 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, using proprietary Nanoluté Technology. MagicTouch SCB has been used in >50,000 patients in major global markets.
About Concept Medical 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.
Photo –
Logo –
SOURCE Concept Medical
For further information: Media: Roshan Belose, [email protected], +91 (0)2616186889 – ext: 21207
from 8 AM – 10 PM ET


Leave a Comment