USFDA issues world’s first IDE approval to India’s Concept Medical for its Sirolimus drug-coated balloon, MagicTouch

New Delhi: Concept Medical has announced receiving U.S. Food and Drug Administration (FDA)’s Investigational Device Exemption (IDE) approval for the world’s first & made in India Sirolimus coated balloon- MagicTouch for Coronary Artery Diseases.

Concept Medical, a maverick in the medical device industry and based out of Surat, added a chapter in the history of the drug-coated balloon (DCB) Percutaneous coronary intervention (PCI) by receiving an Investigational Device Exemption (IDE) approval. In September 2022, the MedTech conglomerate, Concept Medical, was granted the IDE status for MagicTouch SCB Sirolimus Coated Balloon (SCB) by the US U.S. Food and Drug Administration (FDA), making it the world’s first sirolimus coated balloon in coronary with this title.

The Indian company developed the world’s first Sirolimus-drug Coated Balloon SCB and now has IDE approval for the device. US FDA’s IDE approval allows the investigational device to be used in a clinical study to prove the safety and effectiveness of the device. These clinical studies are conducted to support a pre-marketing authorization (PMA) by the USFDA. As of today, no company has IDE approval for a Drug-Coated Balloon in the USA. This is a proud moment for India as Dr Manish Doshi (Founder and M.D.) has not only given the world its first Sirolimus Coated Balloon (SCB) but also the first IDE approval.

The U.S. currently follows conventional PCI, which uses stents, and since the newer generation of interventionalists and modern-day PCI are leaning towards Drug-Coated Balloons, considering neither the operator nor the patient would prefer having a permanent metal implant, this moment will be a gamechanger for the fraternity as well as for the Company. Concept Medical raised funds for the IDE in 2018, and the SCB has so far received two breakthrough device designations and the IDE title to add to it. The IDE approval has been granted for In-Stent Restenosis (ISR), which will help the company to study the device in this indication in the US population.

“We are thrilled and honoured to gain USFDA IDE approval for our sirolimus drug-coated balloons for the treatment of CAD in the US market and taking a big leap in the Field of Cardiovascular Space for the flagship product ‘MagicTouch’ which is the World’s first Sirolimus Coated Balloon from INDIA making country proud while celebrating Prime Minister Narendra Modi’s 72nd birthday & making his dream campaign of ‘Make in India’ reach new heights,” said Manish Doshi, Concept Medical’s founder, and managing director.

Concept Medical’s MagicTouch SCB is currently the most clinically studied SCB, with more than 7000 patients. Concept Medical has also designed two clinical studies which will soon start enrolling patients in the USA, apart from the already submitted strong pre-clinical and clinical evidence from multiple studies to the FDA.

Whilst the whole world is exploring the option of less metal & Drug-Coated Balloons, with the U.S. being one of the most regulated countries, the patients suffering from heart disease were always scarce on alternatives. Concept Medical seeks to ensure that more and more people are benefitted from the MagicTouch SCB and its technology.