Concept Medical announced today that it commenced the FDA investigational device exemption (IDE) study of its MagicTouch system. MagicTouch, a sirolimus drug-coated balloon (DCB), treats in-stent restenosis (ISR) in coronary artery disease (CAD). Dr. Said Ashraf enrolled the first patient in the MAGICAL-ISR study at the AtlantiCare Institute in Atlantic City, New Jersey. The balloon […]
Concept Medical
Concept Medical wins FDA IDE approval for sirolimus coated balloon to treat superficial femoral artery disease
Concept Medical this week announced it received FDA investigational device exemption (IDE) approval for its sirolimus-coated balloon MagicTouch PTA to treat superficial femoral arteries. The approval is the fourth for the Tampa, Florida-based company’s sirolimus-coated balloon. It has IDE approval for coronary in-stent restenosis, coronary small vessel and below-the-knee indications. Concept Medical’s new IDE approval […]
Concept Medical wins FDA IDE approval to investigate MagicTouch sirolimus coated balloon catheter
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 […]