Synovis Coupler System study shows device is valid alternative to hand-sewn blood vessels

By Lisa Kerner

Erie, Pa., Jan. 25 - Synovis Life Technologies, Inc. published the results of an independent study of its mechanical device for connecting blood vessels (anastomosis) without sutures.

Study data showed that using the Microvascular Anastomotic Coupler System enables a high-quality arterial anastomosis performed in relatively few minutes, according to a company news release.

The study was conducted by a group of microvascular reconstructive surgeons from Yale-New Haven Hospital. In the study, three types of tissue grafts were moved from one part of the body to another. Forty-nine patients, ranging in age from 43 years to 85 years old, underwent a total of 50 microvascular free tissue transfer procedures using the Coupler. Each procedure required one arterial and two venous vessel connections.

The investigators recommended that the Coupler be considered as a valid alternative to hand-sewn anastomoses, according to the news release.

The Coupler, available in 1.0 mm to 4.0 mm sizes, is designed for end-to-end vessel connection, end-to-side connection and interpositional vein grafts. The Coupler stents the vessel and provides an intima-to-intima (inner vessel surface) blood flow surface at the connection reducing the chance of blood clot formation, officials said.

While the Coupler has typically been used to connect veins, the study demonstrated the efficacy of using the device to connect arteries, which have thicker vessel walls.

The results of the independent study were published in the recent issue of the Archives of Otolaryngology - Head & Neck Surgery.

According to the article, investigators found the use of microvascular coupling of free tissue transfer reconstruction following head and neck oncological surgery is equivalent to, or better than, sutured anastomoses.

"We are pleased that this independent study demonstrates the Coupler's performance in joining healthy arteries to be on a par with the Coupler's excellent performance in veins," Karen Gilles Larson, president and chief executive officer of Synovis Life Technologies, said in the release.

"The Coupler has proven to be a very efficacious device that provides surgeons with a high level of assurance of a successful anastomosis, which is considered the critical element in a good surgical outcome in these procedures."

The company recently launched larger 3.5 mm and 4.0 mm Couplers at the combined 2006 Annual Scientific Meeting of the American Association for Hand Surgery, American Society for Peripheral Nerve, and American Society for Reconstructive Microsurgery earlier this month.

Synovis Life Technologies Inc., based in St. Paul, Minn., is a diversified medical device company engaged in developing, manufacturing and bringing to market medical devices for the surgical and interventional treatment of disease.

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