Concept Medical received FDA IDE Approval for ...
US FDA approved Concept Medical’s MagicTouch SCB, a Sirolimus Coated Balloon, for small vessel disease treatment, marking its third IDE approval. This enables pivotal clinical studies for safety and effectiveness, aiming for future PMA. MagicTouch SCB, widely used globally, offers a new option for CAD treatment in the USA, where no FDA-approved drug-coated balloons exist.
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Concept Medical received FDA IDE Approval for ...
US FDA approved Concept Medical’s MagicTouch SCB, a Sirolimus Coated Balloon, for small vessel disease treatment, marking its third IDE approval. This enables pivotal clinical studies for safety and effectiveness, aiming for future PMA. MagicTouch SCB, widely used globally, offers a new option for CAD treatment in the USA, where no FDA-approved drug-coated balloons exist.