Synovis Life Tech's Flow Coupler anastomosis device wins FDA clearance

February 8, 2010 by MassDevice staff

A Synovis Life Technologies Inc. device designed to measure blood flow at anastomosis sites where blood vessels are joined wins clearance from the Food & Drug Administration.

By Brandon Glenn

ST. PAUL, Minnesota — Synovis Life Technologies Inc. (NSDQ:SYNO) received clearance from the Food & Drug Administration for a device that measures blood flow immediately after surgical procedures to connect veins.

The company’s Flow Coupler device connects blood vessels and uses a Doppler sensor to measure blood flow at the site where the veins are joined, called an anastomosis. The sensor provides surgeons with real-time information about blood flow through the site, enabling immediate intervention if the anastomosis becomes blocked.

The device is the next-generation version of Synovis’ Coupler, which is used to connect blood vessels but doesn’t monitor blood flow.

Synovis, founded in 1985, divides its products into three major categories: Staple-line reinforcement, soft-tissue repair and surgical tools.

In 2009, the company’s profits plummeted to $2.7 million from $11.5 million during the prior year. Sales jumped 17 percent, however, to $58 million. CEO Richard Kramp credited the revenue growth to the expansion of its surgical sales force by 40 percent and receiving European regulatory approval for its signature Veritas technology.

That technology converts cow tissue into a type of scaffolding that attracts the body’s own cells and blood vessels, allowing the remodeling of the repaired tissue type. Synovis hopes doctors will use Veritas to help repair kidneys, bladders, breasts and, eventually, hearts.