Brazilian regulatory body ANVISA has given the green light for commercial use of Concept Medical's MagicTouch Sirolimus-Coated Balloon in the treatment of Coronary Artery Disease (CAD).
Concept Medical's MagicTouch Revolutionises Coronary Interventions in Brazil
Concept Medical, a global leader in drug-delivery platforms for coronary and peripheral interventions, has received commercial approval from ANVISA for its flagship product, MagicTouch, Sirolimus-Coated Balloon (SCB), in Brazil. This marks a significant milestone for Concept Medical and a turning point for Drug-Coated Balloon (DCB) adoption in the region.
MagicTouch, the world's first commercially available Sirolimus-Coated-Balloon, holds CE approval, USFDA Breakthrough Device Designation, and five USFDA-IDE approvals across coronary and peripheral indications. Its extensive clinical trial program, involving over 24,000 patients globally, makes it one of the most widely studied SCBs.
Professor Dr Alexandre Abizaid, Director of Interventional Cardiology at Instituto do Coração in São Paulo, commented on the approval, stating that MagicTouch will provide a safer alternative to treat patients with coronary obstructions. MagicTouch reduces the restenosis risk and improves long-term outcomes, unlike stents that leave an implant, thereby lowering long-term risks.
Dr Manish Doshi, Founder and MD of Concept Medical Group, stated that Brazil is the region's largest market for Percutaneous Coronary Interventions (PCI) procedures, and the demand for safer, metal-free therapies like MagicTouch is growing. MagicTouch is now the first and only ANVISA-approved sirolimus-coated balloon in Brazil for Coronary Artery Disease (CAD).
Unlike traditional drug-eluting stents (DES), MagicTouch differentiates the company in a space long dominated by DES players, providing a metal-free option that delivers sirolimus directly to the vessel wall. Concept Medical's commitment to advancing safe and effective therapies for cardiovascular care is underscored by its extensive clinical trial program.
MagicTouch is developed with proprietary NanoluteTM technology for controlled drug delivery. Concept Medical also 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).
While Concept Medical is currently undergoing ANVISA's approval process for its wider DCB and DES portfolio, the approval of MagicTouch in Brazil expands the company's global footprint. For up-to-date and precise information, direct inquiries to Concept Medical are recommended. Regularly checking ANVISA's official website and attending medical technology congresses or reading medical journals can also provide valuable insights.
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