Firefighter™ PTCA Balloon Dilatation Catheter Gains Regulatory Approval in Brazil
Brasilia, Brazil – On June 26, Firefighter™ PTCA Balloon Dilatation Catheter ("Firefighter™ PTCA"), in-house developed by Shanghai MicroPort Medical (Group) Co ("MicroPort®"), received approval from Brazil's National Health Surveillance Agency (in Portuguese, Agência Nacional de Vigilância Sanitária - ANVISA).
Firefighter™ PTCA is used in percutaneous transluminal coronary angioplasty ("PTCA") for coronary dilatation. 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™ PTCA and FOXTROT™ PRO PTCA Balloon Dilatation Catheters, Firefighter™ PTCA has much smaller balloon crossing profile and softer material compared to competitors' products, allowing excellent crossability through stenotic and tortuous lesions and make it possible for two balloon catheters to be accommodated in a 5F guiding catheter, which facilitates physicians to go kissing balloon strategy and other complex operations. The Firefighter™ PTCA that gained regulatory approval in Brazil this time has a total of 43 specifications, covering 12 diameters (1.0mm-4.0mm), and four lengths (6mm, 10mm, 15mm and 20mm).
Before the regulatory approval in Brazil, Firefighter™ PTCA has also gained the CE mark approval. Dr. Linda Lin, First Vice President of MicroPort® International Business, said:" The regulatory approval in Brazil marks the official entry of MicroPort®'s new generation coronary balloon dilatation catheter into the Brazilian market. As Firefighter™ PTCA is permitted to be launched in the European markets, MicroPort® will further diversify our cardiovascular product line, with accelerated product upgrading. With its outstanding performance, Firefighter™ PTCA is expected to help MicroPort® further consolidate and expand its coronary products' market share in the overseas market."
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