Synovis Life Technologies Receives FDA Marketing Clearance For Flow Coupler(R)

Main Category: Vascular
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 10 Feb 2010 - 0:00 PDT

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Synovis Life Technologies, Inc. (Nasdaq: SYNO), has received Food and Drug Administration 510(k) marketing clearance for its Flow Coupler®, an innovative extension of the company's well-established Microvascular Anastomotic Coupler used in several surgical procedures to connect small blood vessels more quickly and with equal or greater reliability than hand suturing. The Flow Coupler incorporates Doppler technology to immediately measure blood flow after connecting the small blood vessels. Synovis will begin a limited launch of the Flow Coupler in the United States during its second fiscal quarter with a full release expected during the company's fiscal third quarter.

"We are extremely pleased to receive FDA marketing clearance for the Flow Coupler - a milestone achievement for Synovis," said Richard W. Kramp, Synovis Life Technologies president and chief executive officer. "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."

The Flow Coupler incorporates a 20MHz Doppler sensor to measure blood flow at the site where the vessel is joined (the anastomosis). The Doppler sensor provides surgeons reliable, real time information about blood flow through the anastomosis, enabling immediate intervention in the event of a blockage at the site. Synovis previously received a U.S. patent on this advanced technology.

Synovis' original Coupler is widely used in microvascular surgery, including breast reconstruction in cancer patients, as well as in several applications in head, neck and hand reconstruction. 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.

Source
Synovis Life Technologies

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