Gujarat based Concept Medical, a multinational medical devices company, has announced that it 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 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 innovative device, MagicTouch PTA, which is aimed to change the treatment of SFA disorders, dramatically improving patient outcomes.
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.
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.
Manish Doshi, MD of Concept Medical, said, “We are very delighted to have received the 4th IDE clearance from the USFDA for MagicTouch PTA in the SFA indication.”
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 innovative device, MagicTouch PTA, which is aimed to change the treatment of SFA disorders, dramatically improving patient outcomes.
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.
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.
Manish Doshi, MD of Concept Medical, said, “We are very delighted to have received the 4th IDE clearance from the USFDA for MagicTouch PTA in the SFA indication.”
