Shanghai, China – Firefighter™ PTCA Balloon Catheter ("Firefighter™"), in-house developed by Shanghai MicroPort Medical (Group) Co ("MicroPort®"), recently obtained the regulatory 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.
As the new generation of high-end balloon catheter MicroPort® elaborately designed, Firefighter™ adopts the most advanced material and structure design and has 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. Ultra low outside diameter 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 primary and lateral branches of bifurcation lesion at the same time. Meanwhile, its balloon properties such as dilatation force and pressure are industry leading. Firefighter™ that gained the CFDA approval has a total of 43 specifications, covering 12 diameters (1.0mm-4.0mm), and four lengths (6mm, 10mm, 15mm and 20mm).
Previously, Firefighter™ has gained the CE mark approval and the approval from Brazil's National Health Surveillance Agency ("ANVISA"). Its CFDA approval marks the official entry of MicroPort®'s new generation coronary balloon dilatation catheter with world-class technologies into the China market, which will help enhance the competitiveness of MicroPort®'s balloon dilatation catheters and further consolidate and expand its coronary products' market share in China.