The US Food and Drug Administration (FDA) has granted the third investigational device exemption (IDE) approval for Concept Medical’s MagicTouch sirolimus-coated balloon (SCB). Along with this latest IDE approval for the treatment of small vessels, Concept Medical received two other IDE approvals for the MagicTouch SCB family of products for the treatment of coronary in-stent restenosis and for below-the-knee treatments.
The current IDE approval will allow Concept Medical to initiate a 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 premarket approval (PMA) application in the USA.
MagicTouch SCB is the world’s first SCB with extensive commercial usage in Europe, major markets of Asia, and the Middle East. More than 100,000 patients have been treated with MagicTouch SCB in these markets.
Currently, there are no US FDA-approved drug-coated balloons (DCBS) for the treatment of coronary artery disease in the USA—physicians use drug-eluting stents or uncoated balloons.
MagicTouch SCB has already been widely studied globally in multiple clinical trials, including the EASTBOURNE Registry (2123 patients), NANOLUTE, and ongoing trials like the TRANSFORM 1, TRANSFORM 2, GINGER, TITAN, and Hybrid Bifurcation drug-eluting balloon. Sirolimus has already proven to be safer in coronary artery disease treatment.
Martin Leon, founder and chairman Emeritus, Cardiovascular Research Foundation (New York, USA), who will lead the coming IDE trials, stresses the importance of this achievement. “The US FDA approval to initiate the MAGICAL-SV Clinical trial using the MagicTouch SCB 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.”