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 will allow Concept Medical to initiate a pivotal clinical study to demonstrate the safety and effectiveness of the MagicTouch PTA sirolimus-coated balloon in femoral and popliteal segments. Data generated from the clinical study will support a future pre-market approval application in the U.S.
MagicTouch PTA is a sirolimus-coated balloon that has had extensive commercial use in Europe, major markets of Asia and the Mid-Eastern markets.
Peripheral arterial disease affects an estimated quarter of a million adults in Europe and North America, according to Concept Medical. It is associated with significant morbidity and mortality, with atherosclerosis being the main cause.
Currently, treatment options for PAD are limited to uncoated PTA balloons, paclitaxel-coated DCBs and a DES, restricting the physician’s choice and alternative for patients. Uncoated balloons have been identified with substandard results post-intervention due to recurrent re-narrowing of arteries, according to Concept Medical. Sirolimus has already proven safety in coronary artery disease treatment and will fill the gap in PAD of safety and efficacy in the future.
“We are extremely proud to have received the fourth IDE approval from the USFDA for MagicTouch PTA in the SFA indication,” Founder Manish Doshi said in a news release. “This milestone underscores our unwavering commitment to advancing medical technology and providing innovative solutions that have the potential to transform patient care.”