Twenty-Five Year Retrospective Study With St. Jude Medical Mechanical Heart Valve Published In Annals Of Thoracic Surgery
The study analyzed 4,480 patients from October 1977--when the world's first St. Jude Medical(R) valve was implanted at the University of Minnesota by Dr. Demetre M. Nicoloff--to October 2002, marking the 25th anniversary of that milestone. The study's primary objectives were to document patient survival and valve-related events or complications during the 25-year period.
An independent database was created to study patients who had received a St. Jude Medical(R) aortic or mitral valve during this timeframe. To ensure accuracy, clinical study documents from prior studies were crosschecked with the new data. These efforts resulted in 95% complete follow-up covering 32,190 patient years.
The paper's conclusion states: "In summary, this extensive experience demonstrates excellent function of the SJM valve in the mitral or aortic position. Valve-related events were low, most commonly caused by patient-related factors as opposed to the presence of a prosthetic valve. Valve-related mortality was low, and there have been no reoperations as a result of valve wear. The SJM valve can be recommended to patients as a prosthesis that will last their lifetime."
"This exhaustive, in-depth study represents the most complete retrospective evaluation of a bileaflet prosthetic valve ever conducted," said Robert W. Emery, M.D., the study's lead author at Cardiac Surgical Associates. "The process involved multiple steps and crosschecks to ensure the completeness and accuracy of all data. These results validate the long-term effectiveness and safety of the St. Jude Medical(R) mechanical heart valve, which is designed to last over a patient's lifetime."
St. Jude Medical has been a world leader in mechanical heart valve technology since the Company's founding in 1976. In November 2004, the Company announced its 1.5 millionth mechanical valve implant in Iwate, Japan--the only heart valve company to achieve this milestone. The Company's most advanced mechanical valve, the SJM Regent(R) valve, offers outstanding hemodynamics while maintaining many of the traditional design features that have established the St. Jude Medical(R) valve as the "gold standard" for almost three decades, a rare achievement in the implantable medical device industry.
"We would like to thank Dr. Emery and his colleagues for undertaking this thorough analysis of the St. Jude Medical(R) mechanical heart valve," said George J. Fazio, President of St. Jude Medical's Cardiac Surgery Division. "More than 1.5 million patients around the world have benefited from the quality and durability of the St. Jude Medical(R) mechanical heart valve. We are committed to continued advancements in our mechanical heart valve franchise, while we also broaden our portfolio of therapies and technologies to enhance surgeons' clinical practice and their patients' care."