ANVISA Grants Commercial Approval to Concept Medical's MagicTouch Sirolimus-Coated Balloon for CAD in Brazil

PNN

Sao Paulo [Brazil], September 17: Concept Medical Group, a global leader in drug-delivery technologies, announced that ANVISA (Agencia Nacional de Vigilancia Sanitaria), Brazil’s Health Surveillance Agency, has granted commercial approval for its flagship MagicTouch, Sirolimus-Coated Balloon (SCB) for CAD treatment. This milestone enables patients to access across Brazil in Latin America, offering a new pathway for managing cardiovascular disease.

The approval enables commercial sales in Brazil, strengthening Concept Medical’s global footprint and advancing its mission to deliver safer, more effective treatment alternatives. The company is also undergoing ANVISA’s approval process for its wider DCB and DES portfolio, building on its robust clinical trial foundation.

MagicTouch is now the first and only ANVISA-approved sirolimus-coated balloon in Brazil for CAD. This positions Concept Medical at the forefront of drug-delivery innovation, breaking market limitations tied to PCBs or DES. It differentiates the company in a space long dominated by DES players, providing physicians and patients with a metal-free option that delivers sirolimus directly to the vessel wall, thereby reducing restenosis risk and improving long-term outcomes.

Prof. Dr Alexandre Abizaid, Director, Interventional Cardiology, Instituto do Coracão at São Paulo, commented:

“Great news to hear that ANVISA has approved the use of the first Sirolimus Coated Balloon, MagicTouch, in Brazil. Backed by robust clinical trials and innovative technology, MagicTouch will surely provide a safer alternative to treat patients with coronary obstructions.”

Dr Manish Doshi, Founder & MD, Concept Medical Group, added:

Latin America bears a high burden of cardiovascular disease as a leading cause of mortality, with nearly half a million PCI procedures annually and Brazil alone accounts for ~200,000, making it the region’s largest market. While DES has long dominated, DCBs are emerging as a strong alternative, driven by demand for safer, metal-free therapies like MagicTouch. We are proud to bring this innovation to patients and physicians in Brazil. ANVISA’s approval marks a milestone for Concept Medical and a turning point for DCB adoption, reinforcing our commitment to advancing safer, more effective therapies worldwide.”

About Concept Medical

Concept Medical is a global leader in innovative drug-delivery platforms for coronary and peripheral interventions. Its flagship MagicTouch is the world’s first commercially available Sirolimus-Coated-Balloon, developed with proprietary Nanolute™ technology for controlled drug delivery. Unlike stents, it leaves no implant, lowering long-term risks. The company also offers a broad portfolio of DCBs and DES, including Abluminus DES+, a novel sirolimus-eluting stent approved especially for CAD patients with Diabetes and AMI. Collectively, with its presence in over 80 Countries, Concept Medical’s technologies have benefited over One Million patients globally. MagicTouch holds CE approval, USFDA Breakthrough Device Designation, and five USFDA-IDE approvals across coronary and peripheral indications. It is also among the most widely studied SCBs, supported by Concept Medical’s extensive clinical trial program of 45+ trials involving over 24,000 patients globally. This evidence base underscores the company’s commitment to advancing safe & effective therapies for cardiovascular care.

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