Device company Teleflex Inc., tells us that its subsidiary Hotspur Technologies, Inc. has received U.S. FDA 510(k) clearance to market the Arrow® GPSCath® Balloon Dilatation Catheters designed for use with .014” guide wires and in 150 cm length. The company says these products enable a variety of peripheral vascular procedures to be performed below the knee with one dual function catheter, potentially reducing procedure time, radiation dosage, and expense for both patients and medical professionals.
Background
The Arrow® GPSCath® Balloon Dilatation Catheter is the first dual functional balloon dilatation catheter that combines angioplasty with the proprietary VisioValve™ Injection System. This innovative combination enables physicians to perform peripheral below the knee angioplasty and inject physician selected fluids, such as contrast media, while maintaining guide wire position.
Company comments
“With this latest product approval we continue our commitment to enabling medical professionals to perform peripheral access procedures that simplify and improve the doctor and patient experience while reducing health care costs,” said Benson Smith, Chairman, President & CEO of Teleflex. Added Smith, “We are excited to bring this innovative product for use in below the knee peripheral interventions to the market.”
source: Teleflex, Inc., Business Wire
published: July 29, 2014 in: Approval/Clearance, Vascular