Concept Medical Earns 4th FDA IDE Nod for MagicTouch PTA

Concept Medical has been granted an investigational device exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) for its sirolimus-coated balloon (SCB) MagicTouch PTA to treat superficial femoral arteries (SFA).
 
The is the company’s fourth IDE approval for its sirolimus-coated balloon. Concept Medical has already gained three other pivotal IDE approvals for its SCB MagicTouch portfolio for coronary in-stent restenosis (ISR), coronary small vessel, and below-the-knee indications.
 
The IDE approval lets Concept Medical begin a pivotal clinical study to show the MagicTouch PTA sirolimus-coated balloon’s safety and effectiveness in femoral and popliteal segments. Data gathered from this study will support a future premarket approval in the U.S.
 
MagicTouch PTA is the world’s first sirolimus-coated balloon, according to the company, with extensive commercial usage in Europe, major Asian markets, and the Mid-Eastern markets. According to the company, it’s also the most clinically studied sirolimus drug-coated balloon (DCB) for peripheral arterial disease (PAD) treatment.
 
“We are extremely proud to have received the 4th IDE approval from the USFDA for MagicTouch PTA in the SFA indication,” Dr. Manish Doshi, founder and M.D. – Concept Medical Group told the press. “This milestone underscores our unwavering commitment to advancing medical technology and providing innovative solutions that have the potential to transform patient care.”