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Concept Medical, an R&D company in the field of drug delivery devices, has received the second Investigational Device Exemption (IDE) approval in Below the Knee (BTK) indication from the US FDA for its Sirolimus Coated Balloon Magic Touch PTA. The breakthrough device designation in BTK was granted earlier by the US FDA. With the recent IDE approval, the company’s first step towards commercializing the product in the US market has been taken. This will be the second such approval the company has received.
The Magic Touch PTA Sirolimus Coated Balloon is an alternative to Drug Eluting Stents for the treatment of blockages in coronary and peripheral arterial disease. Currently, the standard of care in the US for treating the BTK arterial occlusion disease is Plain Old Balloon Angioplasty (POBA) or uncoated balloon, 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.
Concept Medical has the honour of developing the first Sirolimus Coated Drug eluting stent and balloon in the world. The company has received more than 114 patents for its drug delivery platforms. It is worth noting that CMI has already commercialized its products in Europe and EMEA countries. They have also completed Clinical Trials in Japan and are expecting their PMDA soon. This achievement showcases the research capabilities of India in the pharmaceutical segment. The innovation is now granted with two IDE approvals in different indications and with more already in the pipeline.
Prof Sahil Parikh from Columbia University Irving Medical Center – USA, has been encouraging innovative technologies in Peripheral Intervention in the USA. According to him, “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.”
Prof Edward Choke from Sengkang General Hospital – Singapore, one of the early investigators of the Magic Touch PTA Balloon, is conducting an RCT against POBA – FUTURE BTK.
Prof Edward Choke said “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. If successful, this has the potential to be a game changer.”
We are feeling absolutely honored 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, CEO, Concept Medical.
