MagicTouch Sirolimus coated balloon gets US FDA IDE approval for superficial femoral artery disease treatment
Concept Medical Inc, a company specializes in developing unique combination products, announced that the US FDA recently granted an Investigational Device Exemption (IDE) approval for its Sirolimus coated balloon (SCB) MagicTouch PTA for the treatment of superficial femoral arteries (SFA). This marks the fourth IDE approval for the company’s Sirolimus coated balloon.
The company has already received three other pivotal IDE approvals for its SCB MagicTouch family of products for the coronary In-Stent Restenosis (ISR), coronary small vessel and below-the-knee indications.
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.
The IDE approval will allow Concept Medical to initiate pivotal clinical study to demonstrate safety and effectiveness of the MagicTouch 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.