TAMPA, Fla., May 30, 2023 /PRNewswire/ — On May 24, 2023, the US FDA granted an Investigational Device Exemption (IDE) for the Sirolimus Coated Balloon (SCB) MagicTouch PTA from Concept Medical Inc for the treatment of superficial femoral arteries (SFA). This marks the fourth IDE approval for the company’s sirolimus-coated balloon.
The company has already received three other key approvals from IDE for its MagicTouch SCB family of products for the indications of in-stent coronary restenosis (ISR), small coronary vessels, and below the knee.
Peripheral arterial disease (PAD) of the lower extremities affects 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 remain major contributors to PAD.
The IDE approval will allow Concept Medical to initiate a pivotal clinical study to demonstrate the safety and efficacy of the MagicTouch PTA sirolimus-coated balloon in the femoral and popliteal segments. The data generated from this IDE clinical study will support a future US Premarket Approval (PMA) application.
MagicTouch PTA is the world’s first Sirolimus-coated balloon with wide commercial use in Europe, major Asian markets and Middle Eastern markets. It is also the most clinically studied sirolimus drug-coated balloon (DCB) for the treatment of PAD, including the largest RCT vs. paclitaxel DCB and the largest RCT vs. uncoated balloon.
Currently, treatment options for PAD are limited to uncoated PTA balloons, paclitaxel-coated DCBs, and a DES, restricting physician choice and patient alternatives. Uncoated balloons have been identified with poor outcomes post-procedure due to recurrent narrowing of the arteries, and the safety of paclitaxel remains debated due to the drug’s association with long-term mortality. Sirolimus, which has already demonstrated its safety in the treatment of coronary artery disease, will fill this gap in the PAD of safety and efficacy in the near future.
“We are extremely proud to have received the fourth IDE approval from the US FDA for MagicTouch PTA in the SFA indication,” said Dr. Manish Doshi, Founder and Director – Concept Medical Group. “This milestone underscores our unwavering 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-approved sirolimus-coated balloon marketed outside the United States of America for the treatment of de novo, stenotic, and restenotic in-stent lesions in the superficial femoral artery (SFA), popliteal, below knee (BTK) and iliac, using the patented Nanoluté technology.
About Concept Medical Inc. (CMI):
CMI is headquartered in Tampa, Florida with operating offices in the Netherlands, Singapore and Brazil and manufacturing units in India. CMI specializes in the development of unique combination products with proprietary coating technology that can deliver any drug/pharmaceutical agent through the luminal surfaces of blood vessels.
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