Firehawk® and Foxtrot Pro® Obtain Regulatory Approval in Malaysia

Kuala Lumpur, Malaysia - Shanghai MicroPort Medical (Group) Co., Ltd. ("MicroPort®") recently received approval from Malaysia's Medical Device Authority ("MDA") for its in-house developed Foxtrot Pro® Balloon Dilatation Catheter ("Foxtrot Pro®") and Firehawk® Rapamycin Target Eluting Coronary Stent System ("Firehawk®"). This is the first time MicroPort®'s products obtained approval from Malaysia's authority after local medical device law came into effect.
The revolutionary third-generation drug-eluting stent ("DES") Firehawk® is the result of eight years of research and development of MicroPort® and it is the world's first and only target eluting stent. As the world's lowest drug dosage stent, Firehawk® combines the merits of the bare metal stent and DES. It adopts unique in-groove abluminal coating design and target-eluting technique, which allow Firehawk® to achieve the same clinical efficacy with significantly low drug loading, benefiting vascular early healing. Firehawk® that gained the MDA approval has a total of 33 specifications, covering six diameters (2.25mm to 4.00mm), and six lengths (13mm, 18mm, 23mm, 29mm, 33mm, and 38mm).
Foxtrot Pro® is a rapid exchange balloon catheter with excellent crossability and trackability, which offers multiple solutions for complex lesions. The device features seamless connection by laser wielding technique, and advanced "stripe" hydrophilic coating which leads to excellent lubricity during tracking and enhanced stability during inflation. In addition, the special soft-tip makes the balloon catheter tip more pliable. The product offers absolute confidence of kissing balloon through 6F guiding catheter with any model. Foxtrot Pro® that gained the MDA approval has a total of 26 specifications, covering six diameters (1.5mm to 4.0mm), and five lengths (6mm, 10mm, 15mm, 20mm, and 25mm).
Firehawk® and Foxtrot Pro® had already entered into the Malaysia market before gaining MDA approval as the local authority allows products with CE mark approval to be sold to designated hospitals. To meet the bidding requirements of more Malaysian hospitals, enhance product competitiveness, and to cope with the tightening regulations, MicroPort® submitted product applications for MDA approval and successfully gained approval for Firehawk® and Foxtrot Pro®. Dr. Linda Lin, First Vice President of MicroPort® International Business, said: "The MDA approval of Firehawk® and Foxtrot Pro® will pave the way for more innovative products to obtain approval from local authority so as to enter more hospitals and benefit more patients."