MagicTouch SCB receives IDE approval for In-Stent Restenosis indication

by Theleaders-Online | September 19, 2022 4:20 am

TAMPA, Fla., Sept. 19, 2022 /PRNewswire/ — The US FDA has granted an Investigational Device Exemption (IDE) approval for MagicTouch[1] Sirolimus Coated Balloon (SCB) indicated for In-Stent Restenosis (ISR).

US FDA’s IDE approval allows the MagicTouch SCB[3] 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[4], using proprietary Nanoluté Technology[5]. MagicTouch SCB has been used in >50,000 patients in major global markets.

About Concept Medical[4] 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[6]

Source URL: https://theleaders-online.com/magictouch-scb-receives-ide-approval-for-in-stent-restenosis-indication/

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