The IDE approval will allow Concept Medical to gather safety and effectiveness data for the MagicTouch PTA SCB to support a future Premarket Approval (PMA) in the USA, providing patients and physicians with an alternate product for the treatment of BTK arterial disease
Concept Medical Inc. (CMI) is granted the second Investigational Device Exemption (IDE) approval in Below the Knee (BTK) indication, for its Sirolimus Coated Balloon (SCB) MagicTouch PTA. This came after the company got its first IDE approval for MagicTouch SCB for the Coronary ISR indication earlier in September 2022. Magic Touch PTA is indicated for treating “Below the Knee (BTK)” atherosclerotic lesions in Peripheral Arterial Diseases (PAD). Magic Touch PTA has already been granted a breakthrough device designation in BTK from US FDA.
The SCB is used as an alternative to Drug Eluting Stents for treatment of blockages in coronary and peripheral arterial disease. Currently in the USA, Plain Old Balloon Angioplasty (POBA) or uncoated balloon is the standard of care for treating the BTK arterial occlusion disease, along with a few recently approved Paclitaxel Coated Balloons as well as stents. The IDE approval will allow Concept Medical to gather safety and effectiveness data for the MagicTouch PTA SCB to support a future Premarket Approval (PMA) in the USA, providing patients and physicians with an alternate product for the treatment of BTK arterial disease. This will be the first step towards commercialising the product in the US market.
The CE approved MagicTouch PTA SCB Catheter has already been widely studied in multiple clinical trials outside the United States (OUS) and has shown promising safety and efficacy results. The product is currently being investigated in Europe in two randomised controlled trials (RCTs) for the BTK indication. The LIMES RCT is a study designed to compare the MagicTouch PTA SCB against POBA, while the Debate BTK Duell is a study against Paclitaxel coated balloon catheter.
It is currently the most clinically studied Sirolimus DCB, with more than 10,000 patients involved in clinical trial programs across Coronary and Peripheral arterial disease. Concept Medical will soon start enrolling patients in the USA in line with the IDE approval.