MagicTouch SCB receives IDE approval for In-Stent Restenosis indication
TAMPA, Fla., Sept. 17, 2022 /PRNewswire/ -- The US FDA has granted an Investigational Exemption (IDE) approval Device 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 - https://mma.prnewswire.com/media/1901255/MagicTouch.jpg
Logo - https://mma.prnewswire.com/media/1244676/Concept_Medical_Logo.jpg
SOURCE Concept Medical
Legal Disclaimer:
EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.
