Concept Medical this week announced that the FDA has granted an investigational device exemption (IDE) approval for its MagicTouch sirolimus-coated balloon (SCB).
The IDE approval covers the device for treating small vessels in coronary arteries. It was the third IDE approval for the company’s MagicTouch SCB. The IDE approval will allow Concept Medical to initiate a pivotal clinical study to support the safety and effectiveness of the device in small vessel coronary disease.
Along with the IDE approval for treating small vessels, Concept Medical also received two other IDE approvals for the MagicTouch SCB family of products for the treatment of coronary in-stent restenosis indication and below-the-knee indication.
“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,” said Dr. Martin Leon, founder and chair emeritus of the Cardiovascular Research Foundation, who will also lead the coming IDE trials.
Concept Medical touts MagicTouch SCB as one of the first sirolimus-coated balloons with extensive commercial usage in Europe, major markets of Asia and the Middle East markets. More than 100,000 patients have been treated with the device in those markets.