Concept Medical’s MagicTouch PTA SCB Receives IDE Approval to Study Treatment of BTK Arterial Disease

February 13, 2023—Concept Medical Inc. announced that its MagicTouch percutaneous transluminal angioplasty (PTA) sirolimus-coated balloon (SCB) has received FDA investigational device exemption (IDE) approval for the treatment of below-the-knee (BTK) arterial disease.

The IDE approval will allow the company to gather safety and effectiveness data for the MagicTouch PTA SCB to support a prospective premarket approval in the United States.

The CE Mark–approved MagicTouch PTA SCB uses the company’s propriety nanolute technology and is designed to deliver submicron particles of sirolimus to reach the deepest layers of the vessel walls.

The MagicTouch SCB received IDE approval for the treatment of coronary in-stent restenosis in September 2022. The MagicTouch PTA SCB has also been granted FDA Breakthrough Device designation for BTK use.

According to the company, the MagicTouch PTA SCB catheter has been widely studied in multiple clinical trials outside the United States. The device is currently being investigated in Europe in two randomized controlled trials (RCTs) for the BTK indication. LIMES RCT compares the MagicTouch PTA SCB catheter against plain old balloon angioplasty (POBA), which is the current standard of care for the treatment of BTK arterial occlusion disease. The Debate BTK Duell compares the device against a paclitaxel-coated balloon catheter.

Prof. Choke is with Sengkang General Hospital in Singapore and Principal Investigator of FUTURE BTK, another RCT comparing the device against POBA in multiple countries in Asia.

“The field of BTK angioplasty needs effective solutions to its problem of poor patency rates. This is an exciting phase 3 trial that will determine whether the novel MagicTouch PTA SCB can maintain the patency of BTK arteries for a longer period of time, compared with our current gold standard of plain balloon angioplasty,” commented Professor Edward Choke in the press release. “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 peripheral arterial disease. If successful, this has the potential to be a game changer.”