FOXTROT™ NC PTCA Balloon Catheter Gains FDA Approval
Shanghai, China – 11 March, 2015 – Shanghai MicroPort Medical (Group) Co ("MicroPort") recently received 510k approval from US Food and Drug Administration ("FDA") for its in-housed developed FOXTROT™ NC PTCA Balloon Catheter, which is MicroPort's first coronary device that gained FDA approval.
FOXTROT™ NC PTCA Balloon Catheter received its CE mark in September 2013. It was permitted to enter into the Japanese market by Japan's Ministry of Health Labour and Welfare ("MHLW") in September 2005.
FOXTROT™ NC PTCA Balloon Catheter is a sterile, single-use, rapid exchange percutaneous transluminal coronary angioplasty catheter. The design is an integrated shaft system with a balloon near the distal tip. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures. Two radiopaque markers aid in positioning the balloon catheter under fluoroscopy during the procedure. The distal portion of the shaft is coated with a hydrophilic coating to provide lubrication.
FOXTROT™ NC PTCA Balloon Catheter is indicated for the balloon catheter dilatation of the stenotic portion of a native coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion, as well as the post-delivery expansion of balloon expandable stents.
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