São Paulo, Brazil – In a major advancement for cardiovascular care in Latin America, 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 approval opens new avenues for patients across Brazil, providing a novel, metal-free treatment option that could significantly improve the management of cardiovascular disease (CVD), one of the leading causes of mortality in the region.
Expanding Access and Strengthening Global Presence
With ANVISA’s approval, Concept Medical can now begin commercial sales in Brazil, marking a crucial step in expanding its footprint across Latin America. The milestone supports the company’s mission to offer safer and more effective treatment alternatives, while also laying the groundwork for broader acceptance of drug-coated balloon (DCB) therapies.
Concept Medical is also actively pursuing ANVISA approval for its wider portfolio, including other DCB and drug-eluting stent (DES) solutions, leveraging extensive clinical trial data to support its offerings.
A First-of-Its-Kind Treatment in Brazil
MagicTouch is now the first and only sirolimus-coated balloon approved by ANVISA for CAD treatment in Brazil. The technology differentiates itself from conventional drug-eluting stents, providing physicians and patients with a metal-free option that delivers sirolimus directly to the affected vessel walls. This targeted delivery helps reduce the risk of restenosis and promotes better long-term outcomes.
By addressing the limitations of traditional treatment options, MagicTouch positions Concept Medical at the forefront of innovation in the cardiovascular space, offering an alternative where DES solutions have long dominated.
Expert Insights
Prof. Dr. Alexandre Abizaid, Director of Interventional Cardiology at Instituto do Coração in São Paulo, shared his excitement about the development: “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 and MD of Concept Medical Group, emphasized the importance of expanding treatment options in the region: “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.
Looking Ahead
The approval of MagicTouch SCB is a landmark achievement not only for Concept Medical but for the wider cardiovascular community in Brazil and Latin America. As the company continues to build on its clinical success and technological expertise, its broader DCB and DES portfolio holds promise to further revolutionize treatment protocols.
With a focus on innovation, safety, and accessibility, Concept Medical is well-positioned to lead the next wave of advancements in coronary care.
Disclaimer: This article is based on information available from public sources. It has not been reported by EQMint journalists. EQMint has compiled and presented the content for informational purposes only and does not guarantee its accuracy or completeness. Readers are advised to verify details independently before relying on them.
