GEM Flow Coupler - Synovis

(microvascular anastomotic coupling system)

FLOW COUPLER DEVICE AND SYSTEM

The marriage of two trusted technologies The COUPLER and a 20 MHz ultrasonic Doppler.

The FLOW COUPLER DEVICE has been specifically designed for use in end-to-end anastomosis for the detection of blood flow in order to confirm vessel patency intra- and postoperatively at the anastomotic site.1

Early Intervention

• Monitoring of the outflow vein of the flap will detect cessation of venous flow almost immediately
• Interruption of arterial flow will cause a near-immediate loss of the venous Doppler signal

Auditory Feedback

• Loss of an audible signal alerts staff that a potential problem with perfusion exists

Safety and Efficiency

• Reduce needless re-explorations

INDICATIONS FOR USE:

The FLOW COUPLER Device is a single use, implantable device that is intended to be used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. The FLOW COUPLER Device includes a pair of permanently implanted rings which secure the anastomosis and a removable Doppler probe that is press-fit onto one of the rings. When the FLOW COUPLER Device is used in conjunction with the FLOW COUPLER Monitor, the FLOW COUPLER System is intended to detect blood flow and confirm vessel patency intra-operatively and post-operatively at the anastomotic site. Post-operatively, blood flow can be detected on an as needed basis for up to 7 days. The FLOW COUPLER Doppler probe is not intended to be a permanent implant and should be removed 3 to 14 days post-operatively.