Concept Medical has received investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) for its sirolimus-coated balloon (SCB) MagicTouch PTA to treat superficial femoral arteries (SFA).
It is the fourth IDE approval secured by the company for the SCB MagicTouch family of products, which have already received three other necessary IDE approvals for its small coronary vessel, below-the-knee indications and coronary in-stent restenosis.
With the approval, Concept Medical can now begin a pivotal clinical study to demonstrate the MagicTouch PTA SCB’s safety and effectiveness in femoral and popliteal segments.
Data from this clinical study will help submit a future pre-market approval application in the US.
MagicTouch PTA is claimed to be the first SCB with extensive usage in Europe, major Asia and the Mid-Eastern markets.
Additionally, it is the most clinically studied drug-coated balloon (DCB) for the treatment of peripheral arterial disease, which includes the largest randomised control test against the uncoated balloon and head-to-head RCT against the paclitaxel DCB.
The options for treating PAD are currently limited to uncoated PTA balloons, paclitaxel-coated DCBs and a DES, which restrict the choice and alternatives for patients.
With its safety proven in coronary artery disease treatment, sirolimus can fill the gap in PAD for safety and efficacy in the near future.
Concept Medical Group founder and managing director Dr Manish Doshi said: “We are extremely proud to have received the fourth IDE approval from the US FDA for MagicTouch PTA in the SFA indication.
“This milestone underscores our unwavering commitment to advancing medical technology and providing innovative solutions that have the potential to transform patient care.”