Firefighter™ PTCA Balloon Catheter Gains Regulatory Approval in Argentina

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.