FOXTROT™ PTCA Balloon Catheter Gains CFDA Approval

On August 14, Shanghai MicroPort Medical (Group) Co received approval from China Food and Drug Administration ("CFDA") for its in-house developed product, FOXTROT™ PTCA Balloon Catheter. Before this, it was permitted to enter into Japanese market by Japan's Ministry of Health Labor and Welfare ("MHLW") in September 2005, and by now, more than 12,000 sets have been sold in the Japan market. The product received its CE mark in September 2013, and also was granted clearance from US Food and Drug Administration ("FDA") in March 2015.
FOXTROT™ 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 for the purpose of improving myocardial perfusion. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures (12atm).It has a high rated burst pressure (RBP=20atm). The distal portion of the shaft is coated with a hydrophilic coating to provide lubrication, which allows the catheter to move freely in the cardiovascular system, and reach the narrow lesion area smoothly. Two radiopaque markers aid in the positioning of the balloon under fluoroscopy during procedures.
Compared with the most commonly used semi-compliant balloon catheter, as a non-compliant balloon catheter, FOXTROT™ PTCA Balloon Catheter has other unique advantages, in addition to the feature of expanding vascular access for the insertion of the stent. It can be used for the post-delivery expansion of balloon expandable stents, such as the accurate post-delivery expansion after a drug eluting stent deployment, in order to reduce the edge effect and to protect the healthy tissue.
The device features high burst pressure, low compliance and small outer diameter for folding profile, which lead to its excellent pushability, traceability and crossability. From March to November 2013, in Beijing Chao-Yang Hospital, which is affiliated to the Capital University of Medical Sciences, together with other 4 research institutes, 120 cases were conducted with a 10-day follow-up that evaluated the safety and effectiveness of FOXTROT™ PTCA's clinical use. The research provided corroborating evidence for FOXTROT™ PTCA's ultimate official approval and application in China.