Concept Medical Scores Hat-Trick with Third USA FDA IDE Approval for Magictouch Sirolimus Coated Balloon in Small Vessels!

Surat : The US Food and Drug Administration (FDA) has approved Concept Medical Inc.’s (CMI) novel Sirolimus-coated balloon, Magic Touch SCB, for the treatment of Small Vessels (SV) in coronary arteries. This is CMI’s third IDE approval. This achievement follows CMI’s successful IDE submissions and approvals in September 2022 for Magic Touch SCB to treat Coronary In-Stent Restenosis (ISR) and in February 2022 for Magic Touch PTA to treat “Below the Knee” Peripheral Arterial Diseases (PAD).

Up to 30% of PCI patients have small artery disease, and revascularization of these arteries is difficult because to higher rates of technical failure and a higher risk of restenosis with PCI, both of which might need further procedures. Major adverse cardiac events (MACE) may be predicted by the presence of small vessel disease as well. With this IDE clearance, Concept Medical may go on with pivotal clinical trials to evaluate the Magic Touch Sirolimus Coated Balloon for the treatment of small vessel coronary disease. With these results, a PMA application in the United States may be submitted, giving doctors and patients another option for treating CAD.

Over 100,000 patients have been treated with Magic Touch SCB in Europe, major markets in Asia, and the Middle Eastern markets since it was first introduced as the world’s first Sirolimus-coated Balloon and received CE approval. CMI has over 114 issued patents for its drug delivery technologies, including the first Sirolimus Coated Balloon and Drug-eluting stent. The business has even finished Japanese clinical trials, and PMDA clearance is forthcoming in that country. CMI now has access to the US market thanks to these IDE clearances from the USFDA.

Drug eluting stents and uncoated balloons are the only options for treating CAD in the United States at this time, since the Food and Drug Administration has not yet authorised any drug coated balloons for this purpose. EASTBOURNE Registry (2123 patients), NANOLUTE, and continuing studies like TRANSFORM 1, TRANSFORM 2, GINGER, TITAN, and Hybrid Bifurcation DEB are just some of the many clinical investigations that have previously examined MagicTouch. In the treatment of coronary artery disease, sirolimus has previously been shown to be safer.

Notably, neither the Peripheral nor the Coronary indications for drug-coated balloons have seen any Indian companies get IDE clearance in the United States. The medical research skills of India are shown by CMI’s innovativeness and success in securing three IDE clearances in distinct therapy indications. The healthcare sector, medical practitioners, and patients at large stand to benefit greatly from this breakthrough since it offers a new option for treating CAD and PAD.

The forthcoming IDE trials will be led by Dr. Martin Leon, founder of the Cardiovascular Research Foundation, who explains the significance of this breakthrough as follows: “The FDA-approval to initiate the MAGICAL -SV Clinical trial using the Magic Touch sirolimus-covered balloon with nanolute technology represents a landmark event in our decades-long quest to find an optimal therapy to manage patients with small vessel coronary obstructive disease.”

Dr Manish Doshi, CEO and founder of Concept Medical, remarked on the significance of the three IDE clearances from the US FDA for the company’s Sirolimus drug-coated balloons in the treatment of coronary and peripheral artery disorders. Our flagship product, ‘Magic Touch,’ the world’s first Sirolimus Coated Balloon with origins in INDIA, is making the nation proud as it moves closer to becoming available to patients in the United States.

About MagicTouch SCB:

MagicTouch SCB is a CE marked and commercially marketed Sirolimus-coated balloon developed by Concept Medical, using proprietary Nanoluté Technology. MagicTouch SCB has been used in >50,000 patients in major global markets.

About Concept Medical Inc (CMI):

CMI is headquartered in Tampa, Florida, and has operational offices in The Netherlands, Singapore, and Brazil, with manufacturing units 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 across the luminal surfaces of blood vessels.