India’s Concept Medical announced receiving U.S. Food and Drug Administration’s Investigational Device Exemption (IDE) approval for its medical device, MagicTouch, a drug-coated balloon used as a percutaneous intervention for coronary artery diseases.
Based out of Surat, Gujarat and headquartered in Tampa, FL, the company has developed a Sirolimus Coated Balloon. Sirolimus is an immuno-suppressive drug that has been used to prevent rejection of kidney transplants. The approval allows the investigational device to be used in clinical studies to prove its safety and effectiveness. As of today, no company has IDE approval for a Drug-Coated Balloon and most such treatments are delivered via drug eluting stents which are permanently implanted.
“U.S. hearts will be treated by made-in-India, MagicTouch from Concept Medical, says Dr. Manish Doshi, founder and managing director of the company. Envision Scientific Pvt. Ltd., an affiliated company of Concept Medical is the sole manufacturing entity. It conducts R&D, and manufactures products to treat cardiovascular and peripheral diseases.
