Gujarat based mostly Idea Medical, a multinational medical units firm, has introduced that it has obtained its fourth Investigational System Exemption (IDE) approval from the US Meals and Drug Administration (USFDA) for the remedy of Superficial Femoral Arteries (SFA).
The Firm has already obtained three different pivotal IDE approvals for its SCB Magic Contact household of merchandise for the coronary In-Stent Restenosis (ISR), Coronary Small Vessel and Beneath-the-Knee indications. The 4th IDE approval is for his or her modern system, MagicTouch PTA, which is aimed to alter the remedy of SFA issues, dramatically enhancing affected person outcomes.
Decrease extremity Peripheral Arterial Illness (PAD) impacts an estimated quarter million adults in Europe and North America and is related to vital morbidity and mortality, with atherosclerosis being the primary trigger. Stenosed and occluded SFA stay main contributors to the PAD.
Magic Contact PTA is the world’s first Sirolimus coated balloon with in depth industrial utilization in Europe, main markets of Asia and the Mid-Jap markets.
The IDE approval will enable Idea Medical to provoke medical examine to show security and effectiveness of the Magic Contact PTA Sirolimus coated balloon in femoral and popliteal segments. The info generated from this IDE medical examine will help a future pre-market approval (PMA) utility within the USA, finally making MagicTouch accessible to sufferers in want.
Manish Doshi, MD of Idea Medical, stated, “We’re very delighted to have obtained the 4th IDE clearance from the USFDA for MagicTouch PTA within the SFA indication.”
The Firm has already obtained three different pivotal IDE approvals for its SCB Magic Contact household of merchandise for the coronary In-Stent Restenosis (ISR), Coronary Small Vessel and Beneath-the-Knee indications. The 4th IDE approval is for his or her modern system, MagicTouch PTA, which is aimed to alter the remedy of SFA issues, dramatically enhancing affected person outcomes.
Decrease extremity Peripheral Arterial Illness (PAD) impacts an estimated quarter million adults in Europe and North America and is related to vital morbidity and mortality, with atherosclerosis being the primary trigger. Stenosed and occluded SFA stay main contributors to the PAD.
Magic Contact PTA is the world’s first Sirolimus coated balloon with in depth industrial utilization in Europe, main markets of Asia and the Mid-Jap markets.
The IDE approval will enable Idea Medical to provoke medical examine to show security and effectiveness of the Magic Contact PTA Sirolimus coated balloon in femoral and popliteal segments. The info generated from this IDE medical examine will help a future pre-market approval (PMA) utility within the USA, finally making MagicTouch accessible to sufferers in want.
Manish Doshi, MD of Idea Medical, stated, “We’re very delighted to have obtained the 4th IDE clearance from the USFDA for MagicTouch PTA within the SFA indication.”
