RELEASE: Concept Medical Receives IDE Approval for Its MagicTouch Sirolimus-Coated Balloon Catheter

- Concept Medical receives IDE approval to investigate the safety and efficacy of its MagicTouch sirolimus-coated balloon catheter for the treatment of small coronary artery disease

TAMPA, Fla., May 1, 2023 /PRNewswire/ -- The US FDA has granted an Investigational Device Exemption (IDE) for Concept Medical Inc.'s new MagicTouch sirolimus-coated balloon (SCB) for the treatment of small vessels (SV) in coronary arteries.

On April 25, 2023, the US FDA granted the third IDE approval for Concept Medical's MagicTouch SCB sirolimus-coated balloon. Along with this latest IDE approval for the treatment of the small vessel indication, Concept Medical received two other IDE approvals for the MagicTouch SCB family of products for the treatment of the coronary stent restenosis (SRI) indication and the below-grade indication. the knee (ATP).

Small-vessel myocardial revascularization remains a challenge due to the increased rates of technical failure after coronary artery bypass grafting and the increased risk of restenosis with PCI associated with repeat procedures. Small vessel disease also remains an independent predictor of major adverse cardiac events (MACE).

The current IDE approval will allow Concept Medical to initiate a pivotal clinical study to support the safety and efficacy of MagicTouch SCB in small vessel coronary disease. The data generated from this IDE clinical study will support a future application for premarket approval (PMA) in the United States.

MagicTouch SCB is the world's first sirolimus-coated balloon with wide commercial use in Europe, major Asian markets, and Middle Eastern markets. More than 100,000 patients have been treated with MagicTouch SCB in these markets.

Currently, there are no FDA-approved drug-coated balloons for the treatment of CAD in the United States. Physicians' options are limited to drug-eluting stents and bare balloons. The MagicTouch SCB has already been extensively studied worldwide in multiple clinical trials, including the EASTBOURNE Registry (2123 patients), NANOLUTE, and ongoing trials such as TRANSFORM 1, TRANSFORM 2, GINGER, TITAN, and the Bifurcation Hybrid DEB. . Sirolimus has already been shown to be safer in the treatment of coronary artery disease.

Dr. Martin Leon, MD (Founder and Chairman Emeritus of the Cardiovascular Research Foundation), who will lead the upcoming IDE trials, underscores the importance of this achievement: "FDA approval to initiate the MAGICAL-SV clinical trial with the Sirolimus-coated MagicTouch with novel coating technology represents a milestone in our decades-long search for an optimal therapy to treat patients with small-vessel obstructive coronary disease.Our US clinical investigators are excited and eager to begin recruitment in close collaboration with the Cardiovascular Research Foundation and Concept Medical".

About MagicTouch SCB:

MagicTouch SCB is a commercialized, CE marked sirolimus-coated balloon developed by Concept Medical, using Nanoluté technology. MagicTouch SCB has been used on more than 50,000 patients in major world markets.

About Concept Medical Inc (CMI):

CMI is headquartered in Tampa, Florida with operating offices in the Netherlands, Singapore and Brazil, as well as manufacturing units in India. CMI specializes in the development of unique combination products with a proprietary coating technology that can deliver any drug/pharmaceutical agent through the luminal surfaces of blood vessels.

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