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St. Jude Aortic Connector
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Silver-Coated Heart Valves Recalled

Jan 24, 2000 |

A U.S.-based company has recalled all implants of a new type of heart valve because the silver coating intended to reduce heart infections may cause the valve to leak.

St. Jude Medical Inc. of Minnesota recalled inventories of St. Jude's heart valves with Silzone coating that have not yet been implanted into patients.

Valves already implanted and the St. Jude's valves that do not contain the silver coating were not recalled. St. Jude Medical said the incidence of leakage was not high enough to require the valves be explanted (removed) from patients not experiencing trouble.

About one per cent of all heart valves leak, while the incidence with silver-coated valves appears to be about two per cent.

The valves were coated with silver because the metal can have antibiotic properties, which could help lead to fewer heart infections, a serious risk for all heart valve recipients.

About 36,000 of the silver-coated valves have been implanted into patients worldwide. About 2,000 have been distributed in Canada.

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