The company has already received three other pivotal 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
Concept Medical has received its fourth Investigational Device Exemption (IDE) approval from the United States Food and Drug Administration (USFDA) 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 the coronary In-Stent Restenosis (ISR), Coronary Small Vessel and Below-the-Knee indications. The 4th IDE approval is for their MagicTouch PTA, which is aimed to change the treatment of SFA disorders, dramatically improving patient outcomes.
Magic Touch PTA is 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 IDE approval will allow Concept Medical to initiate pivotal 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.
Manish Doshi, MD, Concept Medical, said, “We are very delighted to have received the 4th IDE clearance from the USFDA for MagicTouch PTA in the SFA indication. This achievement demonstrates our unwavering dedication to advancing medical technology and providing innovative solutions with the potential to transform patient care.”
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