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.
Source: Concept Medical