Concept Medical Inc (CMI) has been granted the second Investigational Device Exemption (IDE) approval in Below the Knee (BTK) indication, for its Sirolimus coated balloon Magic Touch 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 with a breakthrough device designation in BTK from US FDA.

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CMI, a company which carries out R&D in the field of drug delivery devices, has the honour of developing first Sirolimus Coated Drug eluting stent and balloon in the world. CMI is granted more than 114 patents for its drug delivery platforms. This milestone allows the company an access to the US market. It is pertinent to note that CMI has commercialised its products in Europe and EMEA countries. They have also completed Clinical Trials in Japan and soon expecting for their PMDA in Japan.

The Sirolimus Coated Balloon is used as an alternative to Drug Eluting Stents for treatment of blockages in coronary and peripheral arterial disease. Currently in 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 Magic Touch PTA Sirolimus Coated Balloon 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 commercializing the product in the US market.

The CE approved Magic Touch PTA Sirolimus Coated Balloon 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 randomized controlled trials (RCTs) for the BTK indication. The LIMES RCT is a study designed to compare the Magic Touch PTA Sirolimus Coated Balloon Catheter against POBA, while the Debate BTK Duell is a study against Paclitaxel coated balloon catheter.

Prof. Sahil Parikh (Columbia University Irving Medical Center, USA), who has been encouraging innovative technologies in Peripheral Intervention in the USA, stated that “Concept Medical’s proposed clinical trial studying the Magic Touch PTA in BTK indication will collect significant data on safety and efficacy of the device, thus paving its way to treat patients in the US. With Sirolimus Coated Balloon already receiving an IDE approval in coronary arteries and breakthrough device designations for multiple indications, along with the vast OUS clinical data, it will surely be looked up to by the US physicians and patients with PAD.”

First Published:Feb 16, 2023 5:51 PM IST