St. Paul, MN, March 9, 2004 -- St. Jude Medical, Inc. (NYSE: STJ) announced today that data from its RHYTHM (Resynchronization HemodYnamic Treatment for Heart Failure Management) ICD clinical trial showed a statistically significant improvement in peak VO2 and exercise duration for patients treated with cardiac resynchronization therapy (CRT). All prospectively defined primary safety and efficacy endpoints of the study were successfully met. The announcement was made today in conjunction with the American College of Cardiology's 2004 Scientific Session in New Orleans, Louisiana.
"The Epic HF ICD evaluated in this study effectively combines pacemaker therapy, defibrillation therapy and left-heart stimulation to treat the complexities of heart failure," said Kyong T. Turk, M.D., of the Nebraska Heart Institute, Lincoln, Nebraska, who enrolled the most patients in the RHYTHM clinical study. "These multiple sophisticated therapies in one compact, easy to implant device give me significant flexibility to optimize patient care."
The primary efficacy endpoint of the RHYTHM ICD study was improvement in cardiac function as measured by patient peak VO2 during cardiopulmonary exercise testing. The clinical trial was sized based on an expectation that the CRT arm of the study would show a 1.6 ml/kg/min improvement in peak VO2 compared with the control group, which did not have the CRT feature activated. The actual observed improvement level for CRT compared to control was 1.93 ml/kg/min, which was statistically significant (p=0.001). Secondary endpoints concerning NYHA class and Quality of Life were also statistically significantly improved with CRT (p=0.048 and p=0.009, respectively), with the six minute walk test demonstrating a strong trend toward significance (p=0.07). The study evaluated resynchronization effectiveness, defibrillation system efficacy, defibrillation system safety and left ventricle lead performance.
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