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Concept Medical bags second IDE approval from US FDA

Magic Touch PTA is indicated for treating Below the Knee (BTK) atherosclerotic lesions in Peripheral Arterial Diseases (PAD)

Surat-based Concept Medical has been granted the second Investigational Device Exemption (IDE) approval in the 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.

Concept Medical is a company that carries out R&D in the field of drug delivery devices and has the honour to develop the first Sirolimus Coated Drug-eluting stent and balloon in the world. CMI is granted more than 114 patents for its drug delivery platforms. The milestone allows the company access to the US market.

The Sirolimus Coated Balloon is used as an alternative to Drug Eluting Stents for the treatment of blockages in coronary and peripheral arterial disease. This will be the first step towards commercialising 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 US 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 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, “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 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.

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