Firefighter™, Foxtrot® Pro, and Foxtrot® NC Gain Regulatory Approval in India

New Delhi, India – On December 27, Shanghai MicroPort Medical (Group) Co., Ltd. ("MicroPort®") gained the approval from India's Central Drugs Standard Control Organization ("CDSCO") for its in-house developed Firefighter™ PTCA Balloon Catheter ("Firefighter™"), FOXTROT™ NC PTCA Balloon Catheter ("FOXTROT™ NC"), and FOXTROT™ PRO PTCA Balloon Catheter ("FOXTROT™ PRO"). They are the first batch of balloon catheters of MicroPort® that gained regulatory approval in India, marking the official entry of its new generation balloon catheter in the India market.
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®") to pre-dilate the lesion before the implantation of the stent. Firefighter™ features much smaller balloon crossing profile and softer material compared to competitors' products, leading to excellent crossability through stenotic and tortuous lesions. Its ultra low profile allows two balloon catheters to be accommodated in a 5F guiding catheter, which facilitates physicians to adopt kissing balloon strategy. Firefighter™ that gained the regulatory approval in India has a total of 43 specifications, covering 12 diameters (1.0mm-4.0mm) and four lengths (6mm, 10mm, 15mm and 20mm).
Foxtrot® Pro is also indicated for pre-dilating the stenotic atherosclerotic lesions of coronary artery disease to facilitate the implantation of stent. The product offers multiple solutions for complex diseases with excellent crossability and trackability Foxtrot® Pro adopts internationally advanced new material and new "stripe" hydrophilic coating which leads to excellent lubricity during tracking and enhanced stability during inflation. It also features seamless connection by laser wielding technique as well as special soft-tip that make the balloon catheter tip more pliable. Foxtrot® Pro that gained the CDSCO approval has a total of 26 specifications, covering six diameters (1.5mm to 4.0mm) and five lengths (6mm, 10mm, 15mm, 20mm, and 25mm).
Foxtrot® NC is indicated for pre-dilation as well as post-dilation. The shaft has a combination of single lumen and dual lumens tubing and is made from high polymer material with high pressure resistance. Foxtrot® NC is a low-compliant balloon catheter and has a short deflation time. Super hydrophilic coating allows the catheter to move freely in vessels and reach the narrow lesion area smoothly. Two radiopaque markers aid in the positioning of the balloon under fluoroscopy during procedures. Foxtrot® NC has excellent crossability, trackability and pushability. Foxtrot® NC approved in India has a total of 60 specifications, covering 10 diameters (2.2mm to 5.0mm) and six lengths (6mm, 8mm, 10mm, 12mm, 15mm and 20mm).
Previously, Firehawk® was approved to enter the India market, and has gained high recognition from physicians and patients with its excellent performance. As Firefighter™, Foxtrot Pro®, and Foxtrot® NC gained approval in India, they will further diversify MicroPort®'s cardiovascular product line in India and offer more comprehensive solutions for local patients. With their outstanding performance, they are expected to help MicroPort® further consolidate and expand its market share of cardiovascular products in India and other overseas markets.