Concept Medical granted IDE approval for Magic Touch sirolimus DCB below the knee


SIRONAThe Magic Touch percutaneous transluminal angioplasty (PTA) sirolimus drug-coated balloon catheter (DCB) has received investigational device exemption (IDE) for the treatment of below-the-knee (BTK) atherosclerotic lesions in peripheral arterial disease (PAD). Concept Medical received its first IDE approval for the Magic Touch for coronary in-stent restenosis (ISR) indication in September 2022. The Magic Touch has also been granted with a breakthrough device designation in BTK by the US Food and Drug Administration (FDA).

Currently, plain balloon angioplasty (POBA) is the standard of care for the treatment of the BTK arterial occlusion disease, along with 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 alternative product for the treatment of BTK arterial disease.

The CE-marked Magic Touch has already been widely studied in multiple clinical trials outside the USA 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 Magic Touch with POBA, while the Debate BTK Duell is compares the Concept Medical catheter with a paclitaxel-coated balloon catheter.

Sahil Parikh (Columbia University Irving Medical Center, New York, 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 USA. With the sirolimus-coated balloon having already received an IDE approval in coronary arteries, and breakthrough device designations for multiple indications, along with the vast clinical data [outside the USA], it will surely be looked up to by the US physicians and patients with PAD.”

Edward Choke (Sengkang General Hospital, Singapore), one of the early investigators of the Magic Touch PTA balloon, is also conducting a RCT against POBA (FUTURE BTK) adds, “the field of BTK angioplasty needs effective solutions to its problem of poor patency rates. This is an exciting phase III trial that will determine whether the novel Magic Touch PTA can maintain the patency of BTK arteries for a longer period of time, compared with our current gold standard of POBA. This is a key goal in our efforts to reduce the number of repeated interventions and to save the legs of our patients with the severest form of PAD. If successful, this has the potential to be a game-changer.”


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