Concept Medical Inc. Receives FDA IDE Approval for Magic Touch PTA Sirolimus-Coated Balloon for Below-the-Knee Peripheral Artery Disease

Tampa, FloridaFebruary 14, 2023/PR Newswire/ --Concept Medical Inc.Concept Medical Inc.'s (CMI) Magic Touch Sirolimus-Coated Balloon received FDA Investigational Device Exemption (IDE) approval on February 9, 2023.

Magic Touch PTA Sirolimus Coated Balloon CatheterIndicated for the treatment of atherosclerotic lesions in below-the-knee (BTK) peripheral artery disease. Previously, under CMI...Magic TouchThe Sirolimus Coated Balloon received IDE approval for the first time in September 2022 for the indication of coronary artery ISR. The Magic Touch PTA Sirolimus Coated Balloon Catheter was also granted Breakthrough Device Designation by the US FDA for BTK.

Currently, plain old balloon angioplasty (POBA) is the standard treatment for BTK arterial occlusive disease. Additionally, there are a few recently approved paclitaxel-coated balloons and stents. The IDE approval will enable Concept Medical to gather safety and efficacy data for the Magic Touch PTA sirolimus-coated balloon to support future Pre-Market Approval (PMA) in the United States, offering patients and doctors an alternative product for treating BTK arterial disease.

With CE MarkMagic Touch PTA Sirolimus Coated Balloon CatheterIt has been extensively studied in multiple clinical trials outside the United States (OUS) and has demonstrated promising safety and efficacy results. The product is currently undergoing two randomized controlled trials (RCTs) in Europe for BTK indications. Among them, the LIMES randomized controlled trial is a study comparing the Magic Touch PTA Sirolimus-Coated Balloon Catheter with POBA, while Debate BTK Duell is a study on paclitaxel-coated balloon catheters.

Professor Sahil Parikh from the Columbia University Irving Medical Center in the United States has been encouraging innovative technologies in the field of peripheral interventions in the U.S. He stated, "The clinical trial of Magic Touch PTA proposed by Concept Medical for BTK indications will collect crucial data on the safety and efficacy of the device, paving the way for its use in treating patients in the United States. The sirolimus-coated balloon has already received IDE approval for coronary artery treatment and breakthrough device designation for multiple indications, along with extensive clinical data from outside the U.S., which will undoubtedly attract attention from U.S. PAD physicians and patients."

Professor Edward Choke from Sengkang General Hospital, SingaporeMagic Touch PTA Balloon"One of the early researchers, with the most extensive experience in the device, and is also conducting randomized controlled trials for POBA and future BTK. He added, 'The field of BTK angioplasty needs an effective solution to address its low patency rates. This is an exciting Phase III trial. It will determine whether the new Magic Touch PTA Sirolimus-Coated Balloon can maintain BTK artery patency for a longer duration compared to our current gold standard of plain balloon angioplasty. This is a key goal in our efforts to reduce the number of repeated interventions and save the legs of patients with the most severe peripheral artery disease. If successful, it has the potential to be a game-changer.'"