Brazilian health agency ANVISA gives commercial authorization for Concept Medical's Sirolimus-Coated Balloon (MagicTouch) in coronary artery disease treatments.
In a significant development, Concept Medical, a global leader in drug-delivery platforms for coronary and peripheral interventions, has secured commercial approval from ANVISA for its flagship product, MagicTouch. This approval makes MagicTouch the first and only ANVISA-approved sirolimus-coated balloon in Brazil for the treatment of Coronary Artery Disease (CAD).
MagicTouch, the world's first commercially available Sirolimus-Coated-Balloon, is developed with proprietary NanoluteTM technology for controlled drug delivery. Unlike stents, MagicTouch leaves no implant, lowering long-term risks. This metal-free option delivers sirolimus directly to the vessel wall, reducing restenosis risk and improving long-term outcomes.
The approval is a testament to Concept Medical's commitment to advancing safe and effective therapies for cardiovascular care. The company's technologies have benefited over one million patients globally and are present in over 80 countries.
MagicTouch is among the most widely studied Sirolimus-Coated Balloons (SCBs), supported by Concept Medical's extensive clinical trial program of 45+ trials involving over 24,000 patients globally. This extensive research underscores Concept Medical's dedication to ensuring the highest standards of safety and efficacy.
While Drug-Eluting Stents (DES) have long dominated the market, Drug-Coated Balloons (DCBs) are emerging as a strong alternative, driven by demand for safer, metal-free therapies like MagicTouch. This shift towards DCBs is particularly significant in the Latin America region, particularly Brazil, which has a high burden of cardiovascular disease. Nearly half a million Percutaneous Coronary Interventions (PCI) procedures are performed annually in the region, with Brazil accounting for the largest market.
Besides MagicTouch, Concept Medical offers a broad portfolio of DCBs and DES, including Abluminus DES+, a novel sirolimus-eluting stent for CAD patients with Diabetes and Acute Myocardial Infarction (AMI). The company is currently undergoing ANVISA's approval process for its wider DCB and DES portfolio.
Dr Manish Doshi, Founder & MD of Concept Medical Group, stated that the approval marks a milestone for Concept Medical and a turning point for DCB adoption. He reinforced their commitment to advancing safer, more effective therapies worldwide.
Prof. Dr Alexandre Abizaid, Director of Interventional Cardiology at São Paulo, commented that MagicTouch will provide a safer alternative to treat patients with coronary obstructions. He expressed optimism about the potential benefits this approval will bring to patients in Brazil.
With the commercial sales of MagicTouch now possible in Brazil, Concept Medical expands its global footprint, bringing its innovative and safe drug-delivery platforms to more patients in need.
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