Concept Medical Gets 4th IDE Approval From USFDA For Its Sirolimus Coated Balloon
Concept Medical, an innovative medical devices company, 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 informed in a press statement.
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 device, MagicTouch PTA, which is aimed to change the treatment of SFA disorders.
"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 statement 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 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 the near future, the company said.
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, "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", he added.
