Concept Medical gets FDA IDE approval for MagicTouch PTA for Superficial Femoral Arteries
Concept Medical has received investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) for its Sirolimus Coated Balloon (SCB) MagicTouch PTA for the treatment of Superficial Femoral Arteries (SFA).
Superficial Femoral Arteries (SFA) are blood vessels located in the thigh region that supply blood to the lower extremities. They are commonly affected by Peripheral Arterial Disease (PAD), a condition that restricts blood flow and can lead to complications in the lower extremities.
This marks the fourth IDE approval granted to Concept Medical for its Sirolimus coated balloon.
Previously, the Florida-based medical devices manufacturer obtained three pivotal IDE approvals for the SCB MagicTouch family of products, specifically for indications such as coronary In-Stent Restenosis (ISR), Coronary Small Vessel, and Below-the-Knee treatments.
Dr Manish Doshi — Concept Medical Group Founder and M.D. said: “We are extremely proud to have received the 4th IDE approval from the USFDA for MagicTouch PTA in the SFA indication.
“This milestone underscores our unwavering commitment to advancing medical technology and providing innovative solutions that have the potential to transform patient care.”
Superficial Femoral Arteries are often stenosed or occluded, contributing significantly to Peripheral Arterial Disease, a condition that affects an estimated quarter million adults in Europe and North America. Peripheral Arterial Disease is associated with substantial morbidity and mortality, primarily caused by atherosclerosis.
The approval of this IDE will enable Concept Medical to initiate a pivotal clinical study to demonstrate the safety and effectiveness of the MagicTouch PTA Sirolimus coated balloon in the femoral and popliteal segments.
The clinical data generated from this IDE study will be crucial in supporting a future pre-market approval (PMA) application for the device in the United States.
The MagicTouch PTA is not only the world’s first Sirolimus coated balloon with commercial usage in Europe, major Asian markets, and the Middle East, but it is also the most clinically studied Sirolimus Drug Coated Balloon (DCB) for Peripheral Arterial Disease treatment.
Concept Medical’s MagicTouch PTA has undergone extensive research, including the largest head-to-head randomized controlled trial (RCT) comparing it to Paclitaxel DCB, as well as the largest RCT against uncoated balloons. The clinical investigation demonstrates its potential as a safe and effective treatment option for Peripheral Arterial Disease.
Presently, treatment options for Peripheral Arterial Disease are limited to uncoated PTA balloons, paclitaxel-coated DCBs, and drug-eluting stents (DES), which restrict physicians’ choices and alternatives for patients. Uncoated balloons have shown substandard results post-intervention due to recurrent re-narrowing of arteries, while the safety of paclitaxel remains a topic of debate due to its association with long-term mortality.
Sirolimus, a drug already proven safe in coronary artery disease treatment, aims to fill this gap in Peripheral Arterial Disease by offering a promising option in terms of safety and efficacy. With the FDA’s IDE approval, Concept Medical Inc is poised to advance its groundbreaking Sirolimus Coated Balloon, bringing hope to patients suffering from Peripheral Arterial Disease in the near future.