ST. PAUL, Minn., Jan. 25 /PRNewswire-FirstCall/ -- Synovis Life Technologies, Inc. , announced today publication of data showing that using the Microvascular Anastomotic Coupler System (the Coupler), the company’s mechanical device for connecting blood vessels (anastomosis) without sutures, enables a high quality arterial anastomosis performed in relatively few minutes. The Coupler has typically been used to connect veins, but this study shows the efficacy of using the device to connect arteries, which have thicker vessel walls. The study was conducted by a group of microvascular reconstructive surgeons from Yale-New Haven Hospital. The results were published in the recent issue of the Archives of Otolaryngology - Head & Neck Surgery.
The article stated: “In this retrospective review of 50 microvascular free tissue transfers (FTT’s), we found that the use of microvascular coupling of FTT 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,” said Karen Gilles Larson, president and chief executive officer of Synovis Life Technologies. “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.”
In this study, three types of tissue grafts were moved from one part of the body to another. Forty-nine patients underwent a total of 50 microvascular FTT procedures using the Coupler. Each procedure required one arterial and two venous vessel connections. The patients ranged from 43 years to 85 years of age. The investigators concluded that their study series clearly demonstrated the reliability of arterial coupling and recommended that it be considered as a valid alternative to hand-sewn anastomoses. They noted that, at their institution, skilled microsurgeons had no difficulty in quickly mastering the technique, and in fact, most found it less challenging than hand sewing vessels.
Company Launches Larger 3.5 mm and 4.0 mm Couplers
Following a limited market release, Synovis launched the 3.5 mm and 4.0 mm Coupler sizes at the combined 2006 Annual Scientific Meeting of the AAHS (American Association for Hand Surgery), ASPN (American Society for Peripheral Nerve) and ASRM (American Society for Reconstructive Microsurgery) held January 11-17, 2006. The Coupler is the most commonly used non-suture vessel connection system.
About the Coupler System
The Microvascular Anastomotic Coupler System is a mechanical method for the connection of small blood vessels and is available in 1.0 mm to 4.0 mm sizes in half-millimeter increments. Quick and reliable, the Coupler is ideal for use in end-to-end vessel connection, end-to-side connection and interpositional vein grafts. In addition to saving operative time and money, the Coupler stents the vessel and provides a true intima-to-intima (inner vessel surface) blood flow surface at the connection reducing the chance of a blood clot forming. The Coupler is sold through Synovis Micro Companies Alliance of Birmingham, Alabama.
About Synovis Life Technologies
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. For additional information on Synovis Life Technologies and its businesses, visit the company’s Web site at http://www.synovislife.com .
Forward-looking statements contained in this press release are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The statements can be identified by words such as “should”, “could”, “may”, “will”, “expect”, “believe”, “anticipate”, “estimate”, “continue”, or other similar expressions. Certain important factors that could cause results to differ materially from those anticipated by the forward-looking statements made herein include the timing of product introductions, outcomes of clinical trials and regulatory submissions, the number of certain surgical procedures performed, the level of orders from contract manufacturing customers, and the effectiveness of the company’s plan to transition to a direct sales force, as well as the other factors found in the company’s Annual Report on Form 10-K for the year ended October 31, 2005.
Synovis Life Technologies, Inc.
CONTACT: Nancy A. Johnson, +1-612-455-1745, or Marian Briggs,+1-612-455-1742, both of Padilla Speer Beardsley Inc., or Brett Reynolds,CFO of Synovis Life Technologies, Inc., +1-651-796-7300
Web site: http://www.synovislife.com/
