The innovative CROSSER Catheter System consists of a re-usable electronic Generator, high-frequency Transducer, Foot Switch, FlowMate™ Injector (optional) and single-use CROSSER CTO Recanalization Catheter. A CROSSER Catheter is connected to the FlowCardia Generator through the affixed Transducer and the Foot Switch is used to activate the system. The Generator and Transducer convert AC power into high frequency mechanical vibrations which are propagated through a Nitinol core wire to the metal tip of the CROSSER Catheter. During use (or activation of the CROSSER), saline is required to flush the CROSSER Catheter, and a FlowMate Injector or other power injector is required for this purpose.
CROSSER® Catheter
The single-use, Rapid Exchange or OTW CROSSER Catheter is attached to the Transducer and delivered over standard guidewires to the CTO. When the CROSSER Catheter is activated using the foot switch, the Nitinol core wire transmits the vibrational energy to the metal tip of the Catheter. The high frequency mechanical vibration facilitates guidewire passage of the CTO and allows for subsequent balloon angioplasty, debulking, and/or stent placement.
FlowCardia Generator
The FlowCardia Generator and affixed Transducer convert AC power into high frequency mechanical vibration. Generator Features:
• Mounts conveniently to standard I.V. pole
• No Settings or adjustments required
• Foot switch activated
• Emits audible tone when activated
FlowMate™ Injector
The FlowMate Injector is a sterile saline injector for use as an optional accessory to the CROSSER CTO Recanalization System. The FlowMate Injector is designed to infuse saline at a rate of 0.3ml/sec at a maximum of 200 PSI. The Injector is operated by a foot switch and a jumper cable is supplied with the Injector to allow connection to the FlowCardia Generator.
The FlowMate Injector provides unparalleled control, convenience, and system integration to optimize CROSSER Catheter performance.
Control:
• Single foot switch activates FlowMate and Generator
• Physician controls procedure and pace Convenience:
• Fixed injector settings
• Single-operator control CROSSER System Integration:
• Single IV pole houses FlowMate and Generator
• Precise activation and saline delivery optimizes performance
ORDERING INFORMATION
Product Name
US Catalog Number
FlowCardia Generator – CROSSER System Electronics
GEN200
FlowMate™ Injector
INJ100
The CROSSER System Mechanism for CTO Recanalization
The tip of the CROSSER Catheter mechanically vibrates against the face of the CTO at 20,000 cycles per second (20kHz) at a stroke depth of approximately 20 microns. This high frequency, low amplitude, longitudinal stroke pulverizes the CTO by mechanical impact, creating a channel through the CTO. To read more on this topic, please see: Ultrasound Angioplasty. Boston: Kluwer Academic, 1996. 229-240.
