Company Press Release
St. Jude Medical Announces CE Mark and First North American Implant
of Heart Valve With Anti-Bacterial Properties
Anti-Microbial Silzone Coating Designed to Reduce Endocarditis
ST. PAUL, Minn., Sept. 25 /PRNewswire/ -- St. Jude Medical, Inc. (NYSE:STJ) today announced it has received the Conformite Europeene (CE) Mark for the St. Jude Medical(R) mechanical heart valve SJM(R) Masters Series with Silzone(TM) coating, a proprietary impregnation of elemental silver into the valve sewing cuff. In addition, the first implants have occurred in North America of this valve product.
Silzone(TM) is anticipated to reduce post-operative endocarditis, a serious infection that can occur following heart valve surgeries. The first North American surgery was performed in early September by Dr. Paul Hendry at the University of Ottawa Heart Institute. The patient is a 59 year old man diagnosed with critical aortic stenosis and congestive heart failure.
To date, more than 100 St. Jude Medical(R) mechanical heart valves with Silzone(TM) coating have been implanted worldwide. The Company has filed for U.S. Food and Drug Administration (FDA) approval of this valve enhancement.
Commenting on the CE Mark and first North American implant of Silzone(TM), Terry L. Shepherd, President of the St. Jude Medical's Heart Valve Division, said, ``These are both important milestones for our mechanical valve product line with Silzone(TM) coating. With Silzone(TM) on our mechanical valve products, we continue our commitment to offer the best solutions for heart valve disease to our customers and their patients.
``The incidence of endocarditis while rare is not trivial. When this infection does occur, it is very serious, often fatal. This unique silver coating process is available on our valves on an exclusive basis as an extra measure of safety for heart valve surgeries. It represents a natural barrier against bacteria,'' Shepherd concluded.
Endocarditis is an inflammation of the lining of the heart that occurs in approximately 2-6% of heart valve patients. Although the incidence of endocarditis for valve recipients is relatively low, the consequences are often fatal with mortality rates approaching 60%. Surgeons, therefore, are extremely concerned about preventing its occurrence.
After FDA approval is received, St. Jude Medical plans to incorporate the anti-microbial Silzone(TM) coating in a number of its heart valve products.
In vitro testing has shown this silver coating impregnation process (SPI-ARGENT(TM) developed by Spire Corporation of Bedford, Massachusetts) to be an effective anti-microbial agent against a wide range of bacteria, including those that commonly cause endocarditis and has demonstrated virtual elimination of bacterial attachment. The SPI-ARGENT(TM) coating has also been successful in application with other medical devices including orthopedic products, catheters and wound closure devices.
St. Jude Medical, Inc. ( sjm.com ) develops, manufactures and distributes medical devices for the global cardiovascular market. The Company serves patients and its physician customers worldwide with the highest quality products and services including heart valves, cardiac rhythm management systems, specialty catheters and other cardiovascular devices.
SOURCE St. Jude Medical, Inc.
More news for referenced ticker symbols: STJ, and related industries: medical.
Additional news and quotes: Spire Corp - SPIR. |
