PAVE Study Results to be Published in the Journal of Cardiovascular Electrophysiology; Study Shows That Biventricular Pacing Benefits Non-Heart Failure Patients.
ST. PAUL, Minn. -- St. Jude Medical St. Jude Medical, Inc. NYSE: STJ is a $2.9 billion global cardiovascular device company, with headquarters in St. Paul, Minnesota, United States. The company sells products in more than 100 countries and has over 20 operations and manufacturing facilities worldwide. , Inc. (NYSE NYSE
See: New York Stock Exchange :STJ STJ Superior Tribunal de Justica (Brazil)
STJ Supremo Tribunal de Justiça (Portugal)
STJ Superconducting Tunnel Junction
STJ San Giljan (postal locality, Malta) ) today announced that results of the PAVE (Post AV Nodal Having to do with nodes. See node.
NODAL - Interpreted language implemented on Norsk Data's NORD-10 computers. Used by CERN and DESY high energy physics labs to control their accelerator hardware, PADAC and SEDAC. Included trackball input, graphics. Ablation Evaluation) study will be published in the Journal of Cardiovascular Electrophysiology in December 2005. PAVE is the first large-scale study to show the benefits of biventricular pacing in non-heart failure patients. It evaluated biventricular pacing versus right ventricular pacing in patients who had AV nodal ablation (ablate-and-pace) therapy for chronic atrial fibrillation (AF).
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 Atria
The heart has four chambers. The right and left atria are at the top of the heart and receive returning blood from the veins. The right and left ventricles are at the bottom of the heart and act as the body's main pumps. to the ventricles Ventricles
The two chambers of the heart that are involved in pumping blood. The right ventricle pumps blood into the lungs to receive oxygen. The left ventricle pumps blood into the circulation of the body to deliver oxygen to all of the body's organs and tissues. . 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 six-minute walk test
an assessment of a dog's ability to undertake daily activities. .
--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 David, in the Bible
David, d. c.970 B.C., king of ancient Israel (c.1010–970 B.C.), successor of Saul. The Book of First Samuel introduces him as the youngest of eight sons who is anointed king by Samuel to replace Saul, who had been deemed a failure. (Dual Chamber And VVI VVI Vertical Velocity Indicator
VVI Velocity Vector Imaging (trademark of Siemens AG)
VVI Vermont Volunteer Infantry (Civil War)
VVI VVimaging, Inc. Implantable Defibrillator defibrillator, device that delivers an electrical shock to the heart in order to stop certain forms of rapid heart rhythm disturbances (arrhythmias). The shock changes a fibrillation to an organized rhythm or changes a very rapid and ineffective cardiac rhythm to a ) 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.