Brazil’s Health Surveillance Agency Agência Nacional de Vigilância Sanitária (ANVISA) has granted commercial approval to Concept Medical Group for its MagicTouch, Sirolimus-Coated Balloon (SCB) for CAD treatment. This enables patients, 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 and 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.

Professor Dr Alexandre Abizaid, Director, Interventional Cardiology, Instituto do Coração, 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.”

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.

Dr Manish Doshi, Founder and Managing Director (MD), Concept Medical Group, said, “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 accounting 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 advance safer and more effective therapies worldwide.”