Ann Thorac Surg 2001;72:762-763
© 2001 The Society of Thoracic Surgeons
Invited commentary
James D. Fonger, MDa
a Lenox Hill Hospital, New York, NY, USA
e-mail: jfonger@heartnet.org
The Silzone experience with mechanical heart valves suggests important lessons for new medical device development. Silver had been previously shown in vitro to be an effective broad-spectrum antimicrobial agent. In vitro toxicology and biocompatibility tests were satisfactory. In vivo chronic animal testing was performed with a subcutaneous pocket model to demonstrate reduced inflammation and infection of implanted inoculated patches treated with silver compared to controls. Safety and efficacy concerns appeared to have been addressed. When ion beam-assisted vapor deposition of silver on polyster fibrils was shown to result in a uniform and durable coating of the valve sewing ring, the way appeared to be cleared for the introduction of a relatively insignificant change to an excellent existing mechanical heart valve. The . . . [Full Text of this Article]
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Copyright © 2001 by The Society of Thoracic Surgeons.