A previous St. Jude Medical-sponsored trial, DAVID (Dual Chamber And VVI Implantable Defibrillator), demonstrated the potential detrimental effects of active RV pacing in patients with low ejection fractions who received ICD therapy. The PAVE study looked at the potential benefits of pacemaker-based CRT therapy in a patient population required to receive ventricular pacing, and reinforces the conclusions from DAVID that RV pacing in patients with left-ventricular dysfunction may be detrimental.
"Presentation of the PAVE results is yet another milestone in St. Jude Medical's longstanding effort to surround the atrial fibrillation comorbidity with innovative and effective device solutions," said Eric N. Falkenberg, Senior Vice President of Research & Emerging Indications of St. Jude Medical's Cardiac Rhythm Management business.
Data from the PAVE study have been submitted to the U.S. Food and Drug Administration (FDA) in support of a pre-market approval (PMA) application for the St. Jude Medical Frontier™CRT system in post-AV nodal ablation cases. St. Jude Medical reaffirms its previous guidance that it expects FDA approval of this system by the May 2004 NASPE/Heart Rhythm Society meeting.
There were about 37,000 ablate and pace procedures for AF in the United States in 2003. Health Research International predicts an annual growth rate of 18%, with an estimated 63,000 procedures annually by 2006.
DINAMIT was a prospective randomized trial to assess ICD therapy for prevention of death in high-risk patients early after acute myocardial infarction (AMI). Inclusion criteria f
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Contact: Mechal Weiss
mechal.weiss@edelman.com
212-642-7731
Edelman Public Relations
8-Mar-2004