PAVE Study Results to be Published in the Journal of Cardiovascular Electrophysiology; Study Shows That Biventricular Pacing Benefits Non-Heart Failure Patients.
AV nodal ablation is a procedure that removes a collection of specialized cardiac cells that play a role in conducting electrical impulses from the atria to the ventricles. The procedure may be performed when drug therapy cannot control atrial fibrillation (the rapid, unsynchronized quivering of the heart's upper chambers). Patients undergoing AV nodal ablation typically require a pacemaker to regulate their heartbeats.
"The PAVE study demonstrated that patients with chronic atrial fibrillation who had undergone AV nodal ablation enjoyed significant improvement in exercise and functional capacity with biventricular pacing as compared with right ventricular pacing," said Rahul N. Doshi, M.D., a principal investigator in the study. "These findings are already extending the benefits of this therapy to thousands of new patients each year."
The published study results show:
--A statistically significant improvement in cardiac function with biventricular pacing as compared with right ventricular pacing as measured by a six-minute walk test.
--Improved functional capacity with biventricular pacing as measured by peak VO2 and exercise duration. (VO2 is a measure of the maximum amount of oxygen that a person can take in and process during exercise.)
--Fewer deaths of patients who received biventricular pacing (versus right ventricular pacing) during the trial.
Based on these results, the PAVE study suggests that biventricular pacing should be the preferred mode of pacing therapy in patients with chronic AF undergoing AV nodal ablation.
These findings are consistent with the results of the DAVID (Dual Chamber And VVI Implantable Defibrillator) study, also sponsored by St. Jude Medical, which documented the potential detrimental effects of active right ventricular pacing in patients with low ejection fractions. The PAVE study supports the conclusion that right ventricular pacing in patients with left-ventricular (LV) dysfunction may be detrimental.
Data from the PAVE study were submitted to the U.S. Food and Drug Administration in support of approval for the Frontier(TM) II cardiac resynchronization therapy pacemaker (CRT-P). St. Jude Medical is the only company with approved labeling for application of CRT-P in a patient population that includes patients treated with AV nodal ablation for atrial fibrillation, as well as heart failure patients.
Health Research International, which provides objective market research for the pharmaceutical and medical device industries, predicts that about 63,000 AV nodal ablation procedures will be performed each year by 2006, with an annual growth rate of 18%.
St. Jude Medical, Inc. (www.sjm.com) is dedicated to the design, manufacture and distribution of innovative medical devices of the highest quality, offering physicians, patients and payers outstanding clinical performance and demonstrated economic value.
Any statements made regarding St. Jude Medical's anticipated future product launches, regulatory approvals, revenues, earnings, market shares, and potential clinical success are forward-looking statements which are subject to risks and uncertainties, such as those described in the Company's Quarterly Report on Form 10-Q filed on November 8, 2005 (see page 35). Actual results may differ materially from anticipated results.
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|Comment:||PAVE Study Results to be Published in the Journal of Cardiovascular Electrophysiology; Study Shows That Biventricular Pacing Benefits Non-Heart Failure Patients.|
|Date:||Nov 29, 2005|
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