ST. PAUL, Minn., Nov. 15 /PRNewswire-FirstCall/ -- Synovis Life Technologies, Inc. , announced today that data from a study showed that using the company’s Peri-Strips(R) to reinforce the gastric staple line during laparoscopic gastric bypass surgery resulted in a statistically significant reduction in titanium clips used to prevent bleeding and, in turn, operating times. The study was conducted at the S. Giovanni Bosco Hospital and Federico II University, Naples, Italy, by Drs. Luigi Angrisani, Michele Lorenzo, Vincenzo Borrelli, Monica Ciannella, Uberto Andrea Bassi and Paolo Scarano, and the results were published in a recent issue of Obesity Surgery.
“Although intra-operative blood loss was not directly measured in this study, the reduced number of titanium clips applied to reduce bleeding directly relates to fewer bleeding episodes,” commented Dr. Angrisani. “The operating time among patients who received Peri-Strips was lower because of fewer surgical maneuvers required to identify and control the bleeding source.”
This prospective randomized evaluation enrolled 98 morbidly obese patients. Fifty patients received Peri-Strips as a staple-line buttress and 48 received no buttress. Among the patients who received Peri-Strips, a mean of five clips were used to prevent bleeding and the operating time was a mean of 120 minutes. With the patients who did not receive Peri-Strips, a mean of 23 clips were used and the operating times were a mean of 220 minutes.
In laparoscopic surgery, a bloodless operating field is mandatory because bleeding decreases the definition of the image on the laparoscopic view. Irrigating the site, cleansing the camera and controlling the bleeding prolongs operating times and costs. Laparoscopic gastric bypass surgery, which has a shorter recovery period than an open procedure, has become increasingly popular, particularly in Europe.
This is the second recent study that has found significant clinical benefits from the use of Peri-Strips in gastric bypass surgery. On Oct. 5, 2004, Synovis announced that a published study conducted at Baylor University Medical Center, Dallas, cited Peri-Strips as significantly reducing the incidence of gastric staple line leakage, a potentially life-threatening complication. Researchers in the Baylor study also noted that the use of Peri-Strips was associated with a trend toward lower blood loss during surgery.
About Gastric Bypass Surgery
Gastric bypass surgery is considered the “gold standard” procedure for treating severe obesity, one of the fastest-growing areas of medicine. More than 23 million Americans are candidates for bypass surgery. In 2004 estimates are that more than 500,000 people will die of obesity-related disease in the United States, making it the leading cause of preventable death in the nation.
Peri-Strips, Synovis’ biomaterial staple-line buttress, are used in conjunction with surgical stapling devices to provide integrity to a surgical staple line and reduce the risk of life-threatening leakages of air, blood or other bodily fluids, leading to lower costs and better outcomes. In recent years, most Peri-Strips revenue has been driven by the product’s use in gastric bypass surgery.
About Synovis Life Technologies
Synovis Life Technologies, Inc., based in St. Paul, Minn., is a diversified medical device company engaged in developing, designing, 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, the number of certain surgical procedures performed and the level of orders from contract manufacturing customers. A full discussion of factors can be found in the company’s Annual Report on Form 10-K for the year ended October 31, 2003, and the 10-Q for the quarter ended July 31, 2004.
Synovis Life Technologies, Inc.
CONTACT: Nancy A. Johnson of Padilla Speer Beardsley Inc.,+1-612-455-1700, or njohnson@psbpr.com ; or Connie L. Magnuson, CFO of SynovisLife Technologies, Inc., +1-651-796-7300
Web site: http://www.synovislife.com/