Concept Medical Inc.
Tampa, Florida (ots/PRNewswire)
On May 24, 2023, the U.S. Food and Drug Administration (FDA) granted Investigational Device Exemption (IDE) Clearance for Concept Medical Inc.’s MagicTouch PTA sirolimus-coated balloon (SCB) for the treatment of superficial femoral arteries (SFA). . This is the fourth IDE approval for the company’s sirolimus-coated balloon.
The company has already received three other relevant IDE approvals for its SCB MagicTouch product family for indications of coronary in-stent restenosis (ISR), small coronary vessels and below-the-knee.
Peripheral artery disease (PAD) of the lower extremities is estimated to affect a quarter of a million adults in Europe and North America and is associated with significant morbidity and mortality, with atherosclerosis being the leading cause. Stenosed and occluded SFA still make a significant contribution to PAD.
IDE approval allows Concept Medical to initiate a pivotal clinical study to demonstrate the safety and efficacy of the MagicTouch PTA Sirolimus Coated Balloon in femoral and popliteal segments. Data generated from this IDE clinical study will support a future Marketing Authorization Application (PMA) in the US.
MagicTouch PTA is the world‘s first sirolimus-coated balloon, widely used in Europe, major Asian markets and Middle East markets. It is also the most clinically studied sirolimus drug coated balloon (DCB) for PAD treatment, including the largest head-to-head RCT against paclitaxel DCB and the largest RCT against uncoated balloon.
Currently, treatment options for PAD are limited to bare PTA balloons, paclitaxel-coated DCBs, and DES, limiting physician choices and patient alternatives. It has been found that uncoated balloons give poor post-procedure results due to recurrent narrowing of the arteries. The safety of paclitaxel remains controversial as the drug is associated with long-term mortality. Sirolimus, which has already demonstrated its safety in the treatment of coronary artery disease, will close this safety and efficacy gap in PAD in the near future.
“We are very proud to have received the 4th IDE approval from the USFDA for MagicTouch PTA in the SFA indication,” said Dr. Manish Doshi, Founder and MD – Group Concept Medical. “This milestone underscores our relentless commitment to advancing medical technology and delivering innovative solutions that have the potential to transform patient care.”
About MagicTouch PTA:
MagicTouch PTA is a CE-marked sirolimus-coated balloon commercially marketed outside the United States for the treatment of de novo, stenotic and in-stent restenotic lesions in the superficial femoral (SFA), popliteal, below the knee and (BTK) and iliac arteries, using proprietary Nanoluté technology.
About Concept Medical Inc. (CMI):
Headquartered in Tampa, Florida, CMI has offices in the Netherlands, Singapore and Brazil, and manufacturing facilities in India. CMI specializes in developing unique combination products with patented coating technology that can deliver any drug/active pharmaceutical ingredient across the luminal surfaces of blood vessels.
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Original content from: Concept Medical Inc., transmitted by news aktuell