Concept Medical receives 4th IDE Approval from US FDA for MagicTouch Sirolimus Coated Balloon

The device is used for the treatment of Superficial Femoral Artery (SFA)

Concept Medical, a globally recognised leader in innovative medical devices, has achieved a remarkable milestone by becoming the first medical company to receive its fourth Investigational Device Exemption (IDE) approval from the United States Food and Drug Administration (US FDA) to treat Superficial Femoral Arteries (SFA).

The company has already received three other pivotal IDE approvals for its SCB Magic Touch family of products for coronary In-Stent Restenosis (ISR), Coronary Small Vessel and Below-the-Knee indications. The 4th IDE approval is for their groundbreaking device, MagicTouch PTA, which is aimed to change the treatment of SFA disorders, dramatically improving patient outcomes.

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.

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 the 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 safety and efficacy in future.

The IDE approval will allow Concept Medical to initiate a pivotal clinical study to demonstrate the 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.

Manish Doshi, MD, Concept Medical, said, “This achievement demonstrates our unwavering dedication to advancing medical technology and providing innovative solutions with the potential to transform patient care.”