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.