In BTK indication for its Sirolimus Coated Balloon Magic Touch PTA

  Concept Medical Inc. (CMI) is 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 a breakthrough device designation in BTK from US FDA.

CMI, a company which carries out R&D in the field of drug delivery devices has the honour of developing the 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 expect for their PMDA in Japan. This achievement showcases the research capabilities of India in the pharmaceutical segment. With this, the innovation is now granted with two IDE approvals in different indications and with more already in the pipeline.

Presently, no company rooted in India, has IDE approval for a Drug-Coated Balloon in the USA neither in Peripheral nor in Coronary. This is a proud moment for Concept Medical as Dr Manish Doshi has not only given the world its first Sirolimus Coated Balloon but also the first two IDE approvals from India. This will potentially be a game changer for the industry, healthcare professionals and the patients at large.

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 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 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.”   

Prof. Edward Choke (Sengkang General Hospital, Singapore), one of the early investigators of the Magic Touch PTA Balloon and who possibly has the widest experience with the device and is also conducting an RCT against POBA – FUTURE BTK adds, “The field of BTK angioplasty needs effective solutions to its problem of poor patency rates. This exciting phase III trial will determine whether the novel Magic Touch PTA Sirolimus coated balloon can maintain the patency of BTK arteries for a longer period, compared with our current gold standard of plain balloon angioplasty. This is a key goal in our efforts to reduce repeated interventions and 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.”

“We are feeling absolutely honoured to gain two IDE approvals from USFDA for our sirolimus drug-coated balloons for the treatments of CAD & PAD, and taking a step closer to offering innovative treatment options to the US Patients and taking a big leap in the field of Vascular Space for the flagship product ‘MagicTouch’ which is the World’s first Sirolimus Coated Balloon with roots in INDIA making the country proud,” said Dr Manish Doshi, Founder & MD – Concept Medical. 

Concept Medical’s MagicTouch – ‘Sirolimus Coated Balloon’ 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. While the whole world is exploring the options of metal free intervention with Drug-Coated Balloons, and USA being one of the most regulated countries, the patients were always limited on alternatives. Concept Medical seeks to ensure that more and more people are benefited from the Magic Touch PTA Sirolimus Coated Balloon and its technology.