Consumer Alert: St. Jude Heart Valve Replacement and Repair Products

February 7, 2000

On January 24, 2000, St. Jude Medical, Inc. announced that it had initiated a worldwide voluntary recall of all field inventory of heart valve replacement and repair products incorporating its proprietary Silzone® coating on the sewing cuff fabric. St. Jude indicated that while it will no longer distribute products with Silzone, it was not recommending explants of these products unless individual patient monitoring detected complications.

The announcement and actions followed reports in a clinical trial of an unacceptable level of product re-operations to remove and repair silzone valves due to paravalvular leaks. A paravalvular leak is a flow of blood around the artificial valve usually between the valve sewing ring and the heart tissue to which the valve is attached. This trial, sponsored by St. Jude Medical and designed to compare the incidence of endocarditis (a life-threatening, postoperative infection) in valves with and without Silzone coating, also examined all normally reported complications common to heart valve replacement surgery.

According to St. Jude, the clinical trial, known as AVERT (Artificial Valve Endocarditis Reduction Trial), was designed as the largest, most rigorous, prospective clinical trial ever in the prosthetic heart valve industry. St. Jude described the trial as an independent, multi-year, multi-center randomized study intended to follow 4,400 patients to study the efficacy of Silzone coating on the valve sewing cuff fabric in reducing infection following valve replacement surgery. Based on data from the 792 patients enrolled in AVERT as of January 6, 2000, an independent Data and Safety Monitoring Board advised St. Jude Medical on January 21 that further enrollment in the AVERT study was suspended, given an unacceptable level of explants due to paravalvular leakage in the Silzone "arm" of AVERT. Eight explants for paravalvular leak had been reported out of a total of 398 patients enrolled in the Silzone "arm" of AVERT. One explant for paravalvular leak has been reported out of a total of 394 patients in the non-Silzone "arm" of AVERT.

St. Jude stated that Silzone technology was first introduced in 1997 and purportedly had the potential to reduce the incidence of endocarditis in valve procedures. St. Jude Medical estimated there have been approximately 36,000 implants worldwide of St. Jude Medical heart valve replacement and repair products with Silzone coating.  St. Jude has claimed that the reported complication does not involve the valve mechanism itself, but appears to be associated with the Silzone-coated sewing cuff fabric.

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