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Concept Medical Inc. announced that the FDA has granted an investigational device exemption (IDE) approval for the company’s MagicTouch sirolimus-coated balloon (SCB) for the treatment of small vessels in coronary arteries.
The IDE will allow Concept Medical to initiate a pivotal clinical trial to evaluate the safety and effectiveness of the MagicTouch SCB in small vessel coronary disease. The study’s data will support a future FDA premarket approval application in the United States.
Martin Leon, MD, who is Founder and Chairman Emeritus of the Cardiovascular Research Foundation in New York, New York, will lead the coming IDE trials.
Dr. Leon commented in the company’s press release, “The 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 United States clinical investigators are thrilled and anxious to begin enrollment in close collaboration with the Cardiovascular Research Foundation and Concept Medical.”
The company noted that this is the third IDE approval for the MagicTouch SCB family of products; it has also been granted an IDE for a coronary in-stent restenosis indication and a peripheral below-the-knee indication for percutaneous transluminal angioplasty.
The device has received CE Mark approval and is commercially available in Europe as well as major markets in Asia and the Middle East.
The MagicTouch SCB has been widely studied globally in multiple clinical trials, including the EASTBOURNE Registry (N = 2,123 patients), NANOLUTE, TRANSFORM 1, TRANSFORM 2, GINGER, TITAN, and Hybrid Bifurcation DEB, stated the company.
