St. Jude Medical
St. Jude Medical (NYSE:STJ) championed newly published results from the 4-year-old study it used to back its pre-market approval application for the Trifecta heart valve in The Journal of Thoracic and Cardiovascular Surgery.
The St. Paul, Minn.-based company won FDA approval in 2011 for the Trifecta device. The 1,014-patient study behind STJ’s Trifecta PMA application had 18 patients die within 30 days and another 23 die after 31 days, according to the journal’s report, for a linearized mortality rate of 2.7% per late patient-year.
Eight patients in the study (0.8%) had strokes, 17 (1.7%) suffered reversible neurologic events and 2 (0.2%) patients developed systemic embolic events. There were no instances of early valve blood clots, inflammation or clinically significant breakdown of red blood cells. There were 16 late thromboembolic events, including 4 strokes and 12 reversible neurologic events, for a linearized rate of 1.9% per year of follow-up.
Five patients had to have their valves explanted, "including 1 structural deterioration and 4 prosthetic valve endocarditis cases," the study‘s authors wrote. "The St. Jude Medical Trifecta valve is a unique pericardial bioprosthesis with design elements that provide excellent hemodynamic performance while providing ease of implantation. Long-term follow-up continues to confirm the promising results of this innovative bioprosthesis."
St. Jude won CE Mark approval in the European Union for the Trifecta valve in March 2010. The FDA approved the device in April 2011. The company launched the device in Japan last April.
"The Trifecta valve provides an exceptional hemodynamic profile and the strong clinical results support outstanding one-to-two-year performance data. Additionally, the valve has shown minimal leakage," lead author Dr. Joseph Bavaria of the University of Pennsylvania said in prepared remarks. "I have used this valve for more than 5 years and have found it easy to implant and very reliable, making it an excellent choice for managing patients who require valve replacement."
Neither Bavaria nor the report’s other authors disclosed any financial ties to St. Jude.
"The Trifecta valve was designed specifically to address some of the fundamental limitations of previous aortic valves," said Frank Callaghan, president of St. Jude’s cardiovascular division, in prepared remarks. "These outstanding study results offer additional evidence of the value these valves can have for patients with aortic heart disease."
