Firefighter™ PTCA Balloon Catheter Receives Regulatory Approval in South Korea
Seoul, South Korea – On August 14, Firefighter™ PTCA Balloon Catheter ("Firefighter™"), in-house developed by Shanghai MicroPort Medical (Group) Co., Ltd. ("MicroPort®"), received the regulatory approval from the Ministry of Food and Drug Safety ("MFDS") of South Korea. Previously, Firefighter™ has gained the CE mark approval and the approval from Brazil's National Health Surveillance Agency ("ANVISA"), Argentina's National Administration of Drugs named ANMAT, as well as 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 South Korea has a total of 43 specifications, covering 12 diameters (1.0mm-4.0mm), and four lengths (6mm, 10mm, 15mm and 20mm).
Firefighter™ is the third product of MicroPort® that obtained regulatory approval in South Korea, following JIVE PTCA Balloon Catheter and Firehawk®. It is also the second balloon catheter with MFDS approval after JIVE PTCA Balloon Catheter, which is expected to accelerated product upgrading. Firefighter™'s regulatory approval will further diversify MicroPort®'s product offerings in the South Korea market. With its outstanding performance, Firefighter™ is expected to help MicroPort® to consolidate and expand its market share of coronary products in the South Korea market, and meanwhile pave the way for the company to further expand the local market and even the whole Asia-Pacific market to benefit more patients.
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