Synovis Life Technologies has received FDA 510(k) marketing clearance for Flow Coupler, an extension of the company’s microvascular anastomotic coupler used in surgical procedures to connect small blood vessels.
The Flow Coupler incorporates a 20MHz Doppler sensor to measure blood flow at the site where the vessel is joined (the anastomosis). Synovis Life claimed that the Doppler sensor provides surgeons real time information about blood flow through the anastomosis, enabling immediate intervention in the event of a blockage at the site.
Synovis Life said that the Flow Coupler is used in microvascular surgery, including breast reconstruction in cancer patients, as well as in several applications in head, neck and hand reconstruction. Synovis Life also claimed that the device provides a patency rate exceeding that of hand suturing while connecting vessels in approximately one-fifth of the time required by hand suturing, resulting in shorter aschemic time for the transplanted tissue, significant time savings in the operating room and cost savings.
Synovis Life expects to begin a limited launch of the Flow Coupler in the US during its second fiscal quarter with a full release expected during the third quarter.
Richard Kramp, president and chief executive officer of Synovis Life Technologies, said: “We are extremely pleased to receive FDA marketing clearance for the Flow Coupler a milestone achievement for Synovis. The Flow Coupler’s added feature of providing real time blood flow information makes this an extraordinary product which will assist surgeons in ascertaining that critical blood supply to transplanted soft tissue has been achieved.
“We believe the Flow Coupler has more than twice the potential market opportunity of the Coupler, and reinforces our microsurgical group’s position as ‘the microsurgeon’s most trusted resource.’ Our specialized microsurgical sales force is eager to offer surgeons the Flow Coupler.”