FOXTROT™ NC PTCA Balloon Catheter Gains Regulatory Approval in Argentina
Buenos Aires, Argentina – FOXTROT™ NC PTCA Balloon Catheter, in-house developed by Shanghai MicroPort Medical (Group) Co., Ltd. ("MicroPort®"), recently received regulatory approval from the ANMAT, Argentina's National Administration of Drugs, Foods and Medical Devices. Previously, the product had received CE mark and gained approvals from US Food and Drug Administration, China Food and Drug Administration, Japan's Ministry of Health, Labour and Welfare, as well as regulatory authorities in the Philippines, Thailand, Brazil, Mexico and etc.
FOXTROT™ NC PTCA Balloon Catheter is a rapid exchange percutaneous transluminal coronary angioplasty catheter. It is indicated for balloon angioplasty or assisting with balloon expandable stents implantation in pre-dilation as well as post-dilation. The design is an integrated shaft system with a non-compliant balloon near the distal tip. The balloon is designed to provide an inflatable segment of rated diameter and length at recommended pressures. Two radiopaque markers aid in positioning the balloon catheter under fluoroscopy during the procedure. The device features high rated burst pressure, low compliance, and excellent pushability, trackability and crossability.
Aside from FOXTROT™ NC PTCA Balloon Catheter, other coronary interventional products such as Firehawk® Rapamycin Target Eluting Coronary Stent System ("Firehawk®"), FOXTROT™ PRO PTCA Balloon Dilatation Catheter, and Firefighter™ PTCA Balloon Catheter, also gained regulatory approval in Argentina. The official entry of FOXTROT™ NC PTCA Balloon Catheter into the Argentina market will further diversify the portfolio of MicroPort®'s coronary products to provide more comprehensive solutions for patients in Argentina and even the whole South America.
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