Concept Medical’s MagicTouch Sirolimus-Coated Balloon Approved in Brazil

September 19, 2025—Concept Medical Group announced that its flagship MagicTouch sirolimus-coated balloon for the treatment of coronary artery disease has received commercial approval from Brazil’s Health Surveillance Agency—ANVISA, Agência Nacional de Vigilância Sanitária.

The company stated that the approval provides physicians and patients in Brazil with a metal-free option that delivers sirolimus directly to the vessel wall, thereby reducing restenosis risk and improving long-term outcomes.

“Great news to hear that ANVISA has approved the use of the first sirolimus-coated balloon, MagicTouch, in Brazil,” commented Professor Alexandre Abizaid, MD, in the company’s press release. Prof. Abizaid, who is Director, Interventional Cardiology, Instituto do Coração in São Paulo, Brazil, continued, “Backed by robust clinical trials and innovative technology, MagicTouch will surely provide a safer alternative to treat patients with coronary obstructions.”

Concept Medical noted it is also undergoing ANVISA’s approval process for its wider drug-coated balloon and drug-eluting stent portfolio.