Tampa (Florida) [US], May 1 (ANI/PRNewswire): The US FDA has granted an Investigational Device Exemption (IDE) approval for Concept Medical Inc's novel MagicTouch Sirolimus Coated Balloon (SCB) for the treatment of Small Vessels (SV) in coronary arteries.
US FDA, on the 25th of April 2023, granted the third IDE approval for Concept Medical's Sirolimus Coated Balloon - MagicTouch SCB. Along with this latest IDE approval for the treatment of Small Vessel indication, Concept Medical received two other IDE approvals for the MagicTouch SCB family of products for the treatment of coronary In-Stent Restenosis (ISR) indication and Below-the-Knee indication (PTA).
Small vessel disease is common among patients undergoing PCI and has been documented in up to 30 per cent of cases and Myocardial revascularization of small vessels remains challenging owing to increased rates of technical failure following coronary artery bypass graft surgery and an increased risk of restenosis with PCI resulting with repeated interventions. Small Vessel Disease also remains an independent predictor of major adverse cardiac events (MACE).
The current IDE approval will allow Concept Medical to initiate pivotal clinical study to support safety and effectiveness of the MagicTouch SCB in small vessel coronary disease. The data generated from this IDE clinical study will support a future 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.
Currently, there are no FDA approved Drug Coated Balloons for the treatment of CAD in the USA. The physicians' choices are restricted to Drug Eluting Stents and uncoated Balloons. MagicTouch SCB has already been widely studied globally in multiple clinical trials, most notably the EASTBOURNE Registry (2123 patients), NANOLUTE, and ongoing trials like the TRANSFORM 1, TRANSFORM 2, GINGER, TITAN, and Hybrid Bifurcation DEB. Sirolimus has already proven to be safer in coronary artery disease treatment.
Dr Martin Leon, MD (Founder and Chairman Emeritus, Cardiovascular Research Foundation), who will lead the coming IDE Trials, stresses on the importance of this achievement, "The FDA-approval to initiate the MAGICAL-SV Clinical trial using the MagicTouch sirolimus-covered balloon with novel coating technology represents a landmark event in our decades-long quest to find an optimal therapy to manage patients with small vessel coronary obstructive disease. Our US clinical investigators are thrilled and anxious to begin enrolment in close collaboration with the Cardiovascular Research Foundation and Concept Medical."
MagicTouch SCB is a CE-marked and commercially marketed Sirolimus coated balloon developed by Concept Medical, using proprietary Nanolute Technology. MagicTouch SCB has been used in >50,000 patients in major global markets.
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 unique combination products with a patented coating technology that can deliver any drug / pharmaceutical agent across the luminal surfaces of blood vessels.
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