Thursday September 25 12:16 PM EDT
St. Jude's Silzone valve cleared in Europe
ST. PAUL, Minn., Sept 25 (Reuter) - St. Jude Medical Inc said Thursday it received European marketing approval for a mechanical heart valve treated with
Silzone, a substance designed to reduce infections after heart surgery.
The medical devices maker also said that the first North American implants of the Silzone valve have been accomplished.
Silzone, a technology involving impregnation of elemental silver into the valve sewing cuff, is anticipated to reduce post-operative endocarditis, a serious infection that
can occur following heart valve surgeries, St. Jude said.
The first North American implant was performed in early September in Canada, the company said.
To date, more than 100 Silzone valves have been implanted worldwide. The company said it has filed for U.S. Food and Drug Administration approval of the
product.
``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,'' said Terry Shepherd, president of St. Jude Medical's heart valve division.
Endocarditis is an inflammation of the lining of the heart that occurs in about two to six percent of patients who receive man-made valves to replace worn-out natural
ones in their hearts, the company said.
``Although the incidence of endocarditis for valve recipients is relatively low, the consequences are often fatal with mortality rates approaching 60 percent. Surgeons,
therefore, are extremely concerned about preventing its occurrence,'' St. Jude said.
After FDA approval is received, St. Jude said it plans to incorporate the anti-microbial Silzone coating in a number of its heart valve products. |
