The US FDA, on the 24th of May 2023, granted an Investigational Device Exemption (IDE) approval for Concept Medical Inc‘s Sirolimus Coated Balloon (SCB) MagicTouch PTA 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 pivotal IDE approvals for its SCB MagicTouch family of products for the coronary In-Stent Restenosis (ISR), Coronary Small Vessel and Below-the-Knee indications.
Lower extremity Peripheral Arterial Disease (PAD) affects an estimated quarter million adults in Europe and North America and is associated with significant morbidity and mortality, with atherosclerosis being the main cause. Stenosed and occluded SFA remain major contributors to the PAD.
The IDE approval will allow Concept Medical to initiate pivotal clinical study to demonstrate safety and effectiveness of the MagicTouch PTA Sirolimus coated balloon in femoral and popliteal segments. The data generated from this IDE clinical study will support a future pre-market approval (PMA) application in the USA.
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MagicTouch PTA is the world’s first Sirolimus coated balloon with extensive commercial usage in Europe, major markets of Asia and the Mid-Eastern markets. It is also the most clinically studied Sirolimus Drug Coated Balloon (DCB) for PAD treatment, which includes the largest head-to-head RCT against Paclitaxel DCB, and the largest RCT against uncoated balloon.
Presently, the treatment options for PAD are limited to uncoated PTA balloons, paclitaxel coated DCBs and a DES, thus restricting the physician’s choice and alternatives for patients. Uncoated balloons have been identified with substandard results post intervention due to recurrent re-narrowing of arteries, and Paclitaxel safety remains a debate due to association of the drug with long-term mortality. Sirolimus which has already proven safety in coronary artery disease treatment, will fill this gap in PAD of safety and efficacy in near future.
“We are extremely proud to have received the 4th IDE approval from the USFDA for MagicTouch PTA in the SFA indication,” said Dr. Manish Doshi, Founder and M.D. – 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.”
SOURCE: PR Newswire