St. Jude Medical announces CRT patients showed improvement in the RHYTHM...( icant prospective randomized study wh...),Health

icant prospective, randomized study, which adds to the growing body of evidence supporting the therapeutic effectiveness of cardiac resynchronization therapy as an adjunct to optimal medical therapy for heart failure patients," added Eric S. Fain, M.D., Senior Vice President, Development and Clinical/Regulatory Affairs for St. Jude Medical's Cardiac Rhythm Management business. "The RHYTHM study has a rigorous protocol with more stringent inclusion/exclusion criteria than previous studies, so all of the participating RHYTHM ICD investigators should be congratulated on achieving this important milestone."

Patients enrolled in the RHYTHM ICD study have an approved indication for an ICD; symptomatic, advanced heart failure (NYHA Class III/IV) not due to reversible causes, for at least six months, despite receiving optimal pharmacological therapy for a minimum of 90 days; an ejection fraction of = 35% (volume of blood pumped compared to volume filled), and a prolonged QRS duration (ventricular activity shown in an electrocardiogram).

The RHYTHM study evaluated the St. Jude Medical Epic HF model V-338 implantable cardioverter defibrillator (ICD), which is used to treat heart failure patients who are also at risk of dangerously fast heart rhythms (ventricular tachyarrhythmias). The Epic HF ICD offers negative AV/PV hysteresis with search capability designed to ensure a high percentage of biventricular pacing. It's the world's smallest high-voltage cardiac resynchronization device, designed to make implantation easier while improving patient comfort and cosmetic appearance. The device delivers 30 joules of energy in a physiologic-shaped 36-cc ICD.

The device was paired with either the Aescula model 1055K or QuickSite model 1056K left heart lead. During the separate QuickSite phase of the RHYTHM ICD Study, the implant success rate of the QuickSite lead was 94.4%. All prospectively defined endpoints of the QuickSite phase of the study wer
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Contact: mechal weiss
mechal.weiss@edelman.com
212-642-7731
Edelman Public Relations
9-Mar-2004

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