St. Jude's AVERT Trial Data Induce Recall Of Silzone-Coated Heart Valve
This article was originally published in The Gray Sheet
Executive Summary
St. Jude Medical's clinical study of the Regent mechanical heart valve henceforth will use only the non Silzone-coated version of the device, following the Jan. 24 recall of all products incorporating the proprietary antimicrobial coating, the firm says.
You may also be interested in...
St. Jude Silzone class action
Case is filed in Minnesota federal court Feb. 11 on behalf of 10,000-14,000 Europeans with the prosthetic heart valves who may have sustained injuries following implantation between 1997 and January 2000. St. Jude already is defending a separate U.S. class action over 10,500 domestic Silzone recipients, suing for support of an ongoing medical monitoring program that would collect data on the valves and check for possible injury or side effects (1"The Gray Sheet" Jan. 12, 2004, p. 6). The firm recalled Silzone after its postmarket AVERT trial showed the coating was associated with a higher rate of paravalvular leaks than conventional valves (2"The Gray Sheet" Jan. 31, 2000, p. 16)...
St. Jude Silzone class action
Case is filed in Minnesota federal court Feb. 11 on behalf of 10,000-14,000 Europeans with the prosthetic heart valves who may have sustained injuries following implantation between 1997 and January 2000. St. Jude already is defending a separate U.S. class action over 10,500 domestic Silzone recipients, suing for support of an ongoing medical monitoring program that would collect data on the valves and check for possible injury or side effects (1"The Gray Sheet" Jan. 12, 2004, p. 6). The firm recalled Silzone after its postmarket AVERT trial showed the coating was associated with a higher rate of paravalvular leaks than conventional valves (2"The Gray Sheet" Jan. 31, 2000, p. 16)...
Silzone Class Action Against St. Jude Can Go Forward, Minnesota Judge Rules
An approved PMA supplement for St. Jude Medical's Silzone heart valve does not preempt product liability suits, since there is evidence that the firm concealed problems with the device, according to a Jan. 7 ruling