On 24 May, the US Food and Drug Administration (FDA) granted an investigational device exemption (IDE) approval for Concept Medical’s MagicTouch percutaneous transluminal angioplasty (PTA) sirolimus-coated balloon (SCB) for treatment of the superficial femoral artery (SFA).
This marks the fourth IDE approval for the company’s SCB, a press release reports. Concept Medical has already received three other pivotal IDE approvals for its SCB MagicTouch family of products for coronary in-stent restenosis (ISR), coronary small vessel and below-the-knee indications.
The IDE approval will allow Concept Medical to initiate a pivotal clinical study to demonstrate safety and effectiveness of the MagicTouch PTA SCB in femoral and popliteal segments. The data generated from this IDE clinical study will support a future premarket approval (PMA) application in the USA.
According to the company, MagicTouch PTA is the world’s first SCB with extensive commercial usage in Europe, major markets of Asia and the Mid-Eastern markets. Concept Medical further claims that the device is the most clinically studied sirolimus drug-coated balloon (DCB) for peripheral arterial disease (PAD) treatment, referencing the largest head-to-head randomised controlled trial (RCT) against a paclitaxel DCB, and the largest RCT against an uncoated balloon.
“We are extremely proud to have received the fourth IDE approval from the US FDA for the MagicTouch PTA in the SFA indication,” said Manish Doshi, founder and managing director, Concept Medical Group. “This milestone underscores our unwavering commitment to advancing medical technology and providing innovative solutions that have the potential to transform patient care.”