Concept Medical Group, a global leader in drug-delivery technologies, has announced that ANVISA (Agência Nacional de Vigilância Sanitária), Brazil’s Health Surveillance Agency, has granted commercial approval for its flagship MagicTouch Sirolimus-Coated Balloon (SCB) for the treatment of Coronary Artery Disease (CAD). This milestone paves the way for broader patient access across Brazil, offering an innovative new option for managing cardiovascular disease in Latin America.
The approval allows Concept Medical to begin commercial sales in Brazil, reinforcing its global presence and supporting its mission to provide safer, more effective treatment alternatives. The company is also pursuing ANVISA approval for its broader drug-coated balloon (DCB) and drug-eluting stent (DES) portfolio, backed by a strong foundation of clinical trials.
MagicTouch is now the first and only sirolimus-coated balloon approved by ANVISA in Brazil for CAD treatment. This achievement places Concept Medical at the forefront of drug-delivery innovation, disrupting a market traditionally dominated by DES. By providing a metal-free alternative that delivers sirolimus directly to the vessel wall, MagicTouch helps lower restenosis risk and improve long-term outcomes for patients.
“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.” — Alexandre Abizaid, Director, Interventional Cardiology, Instituto do Coração, São Paulo
“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 advancing safer, more effective therapies worldwide.” — Manish Doshi, Founder & MD, Concept Medical Group