Concept Medical, a global leader in innovative medical devices, has received its fourth Investigational Device Exemption (IDE) approval from the United States Food and Drug Administration (USFDA) for the treatment of Superficial Femoral Arteries (SFA). The company has already received three other IDE approvals for its SCB Magic Touch family of products for the coronary In-Stent Restenosis (ISR), Coronary Small Vessel and Below-the-Knee indications.

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"The 4th IDE approval is for the device, MagicTouch PTA, which is aimed to change the treatment of SFA disorders, dramatically improving patient outcomes," Concept Medical said.

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.

Magic Touch 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, the company said.

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.

"The IDE approval will allow Concept Medical to initiate clinical study to demonstrate safety and effectiveness of the Magic Touch 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, eventually making MagicTouch accessible to patients in need," the company said.

First Published:May 30, 2023 5:58 PM IST