MicroPort Scientific : Firefighter™ PTCA Balloon Catheter Gains Regulatory Approval in...

Buenos Aires, Argentina - Firefighter™ PTCA Balloon Catheter ('Firefighter™'), in-house developed by Shanghai MicroPort Medical (Group) Co., Ltd. ('MicroPort'), recently obtained the regulatory approval from the ANMAT, Argentina's National Administration of Drugs, Foods and Medical Devices. Previously, Firefighter™ has gained the CE mark approval and the approval from Brazil's National Health Surveillance Agency ('ANVISA'), and the approval from China Food and Drug Administration ('CFDA').

Firefighter™ is a rapid exchange catheter, indicated for dilating the stenotic atherosclerotic lesions of coronary artery disease to improve myocardial perfusion in patient. It can be used in combination with MicroPort's in-house developed Firehawk Rapamycin Target Eluting Coronary Stent System ('Firehawk'). As the new generation of high-end balloon catheter MicroPort elaborately designed after JIVE™ and FOXTROT™ PRO PTCA Balloon Dilatation Catheters, Firefighter™ adopts the most advanced material and structure design. It also features much smaller balloon crossing profile and softer material compared to competitors' products, leading to excellent crossability through stenotic and tortuous lesions, which makes it suitable for challenging chronic total occlusion ('CTO') lesions. Its ultra low profile allows two balloon catheters to be accommodated in a 5F (1.0-2.0mm) guiding catheter, which facilitates physicians to go kissing balloon strategy, and could benefit main and side branches of bifurcation lesion at the same time. Meanwhile, its balloon properties such as dilatation force and pressure are also industry leading. Firefighter™ that gained the regulatory approval in Argentina has a total of 43 specifications, covering 12 diameters (1.0mm-4.0mm), and four lengths (6mm, 10mm, 15mm and 20mm).

Coronary heart disease is one of the major diseases in Latin America. Currently, Argentina ranked top in the market of Latin America in terms of the amount of PCI cases. Up to date, Firefighter™ has gained regulatory approval in two Latin American countries - Brazil and Argentina. As MicroPort's new generation coronary balloon dilatation catheter, the official entry of Firefighter™ into the Argentina market will diversify the product portfolio of MicroPort's coronary products and further consolidate and expand its coronary products' market share in Argentina.

About MicroPort

MicroPort Scientific Corporation (the 'Group') is a leading medical device company with business focusing on innovating, manufacturing, and marketing high-quality and high-end medical devices globally. With a diverse portfolio of products now being used at an average rate of one for every 15 seconds in thousands of major hospitals around the world, the Group maintains world-wide operations in a broad range of business segments including Cardiovascular, Orthopedic, Electrophysiological, Endovascular, Neurovascular, Surgical, Diabetes Care and Endocrinal Management, and others. MicroPort is dedicated to becoming a patient oriented global enterprise improve and reshape patient lives through application of innovative science and technology.

For more information, please refer to: www.microport.com

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