Concept Medical Receives Third IDE Approval from US FDA for its MagicTouch – Sirolimus Coated Balloon


concept medical (CMI) has received approval from the US Food and Drug Administration (FDA) for its third Investigational Device Exemption (IDE) for its novel sirolimus-coated balloon, Magic. Touch SCB for the treatment of small vessels (SV) in coronary arteries.

to magictouch Third IDE approved for the treatment of small vessel indications. This gives the company IDE approval for Magic Touch SCB for the treatment of coronary in-stent restenosis (ISR) in September 2022 and IDE approval for Magic Touch PTA for the treatment of “below the knee” peripheral arterial disease (PAD) in February 2022 After getting approval. Notably, Magic Touch has already been granted Breakthrough Device Designation by the US FDA in various indications.

Small vessel disease is common in patients undergoing PCI and has been documented in up to 30% of cases, and myocardial revascularization of small vessels is challenging due to increased rates of technical failure after coronary artery bypass graft surgery and the increased risk of restenosis with PCI. It is made up. with frequent interventions. Small vessel disease also remains an independent predictor of major adverse cardiovascular events (MACE).

Approval of the IDE will allow Concept Medical to initiate pivotal clinical studies to collect safety and effectiveness data for the Magic Touch sirolimus coated balloon in small vessel coronary disease. Data generated from this IDE clinical study will support a future pre-market approval (PMA) application in the United States, providing patients and physicians with an alternative product for treating CAD.

CMI has the distinction of developing the world’s first Sirolimus coated balloon and drug-eluting stent, with over 114 patents granted for its drug delivery platform. The CE-approved MagicTouch SCB is the world’s first sirolimus-coated balloon with extensive commercial use in major markets in Europe, Asia, and the Middle East. More than 100,000 patients have been treated with Magic Touch SCBs in these markets. The company has also completed clinical trials in Japan, with PMDA approval expected soon in Japan. These USFDA IDE approvals give CMI access to the US market.

It is noteworthy that no company based in India has received IDE approval in the United States for drug-coated balloons in peripheral or coronary indications. This achievement highlights India’s research capabilities in the medical field. With these three IDE approvals in various treatment indications, CMI’s innovation is progressing in the global market, with more approvals in the pipeline.

This is a significant milestone for Concept Medical, as Dr. Manish Doshi and his team have not only developed the world’s first sirolimus coated balloon, but have also received the first three IDE approvals from India. This achievement has the potential to be a game changer for the healthcare industry, healthcare professionals and patients at large.

Currently, there are no FDA-approved drug coated balloons for the treatment of CAD in the United States, and patients are limited to the availability of drug eluting stents and uncoated balloons. MagicTouch has already been widely studied globally in several clinical trials, notably the Eastbourne Registry (2123 patients), NanoLUT, and ongoing trials such as TRANSFORM 1, TRANSFORM 2, GINGER, TITAN, and hybrid bifurcation DEB . Sirolimus has already been proven safe in the treatment of coronary artery disease.

Dr. Martin Lyons (Founder – Cardiovascular Research Foundation), who will lead the upcoming IDE trials, emphasizes the importance of this achievement “to initiate the MAGICAL-SV clinical trial using the MagicTouch sirolimus-covered balloon with NanoLUT technology The FDA-approval for small vessel coronary obstructive disease represents a landmark event in our decades-long quest to find the optimal therapy to manage patients with coronary artery disease. Our US clinical investigators are thrilled and anxious to begin enrollment in close collaboration with the Cardiovascular Research Foundation and Concept Medical.

In the days to come, smaller ships may not be a big problem for US patients with MagicTouch-SCB.

“We are very honored to have received three IDE approvals from the US FDA for our sirolimus drug-coated balloons for the treatment of coronary and peripheral artery diseases. This brings us closer to offering innovative treatment options to patients in the US and represents a significant leap forward. in the area of ​​vascular space for our flagship product, ‘Magic Touch’, which is the world’s first sirolimus coated balloon with roots in India, is making the country proud,” said Dr. Manish Doshi, Founder and Managing Director, Concept Medical .

About MagicTouch SCB:

MagicTouch SCB is a CE marked and commercially marketed sirolimus coated balloon, developed by Concept Medical, using proprietary NanoLyte technology. MagicTouch SCB has been used in >50,000 patients in key global markets.

About Concept Medical Inc (CMI):

CMI is headquartered in Tampa, Florida with operational offices in the Netherlands, Singapore and Brazil and manufacturing facilities in India. CMI specializes in developing drug-delivery systems and has unique and patented technology platforms that can be deployed to deliver any drug/pharmaceutical agent to the luminal surfaces of blood vessels.


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