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St. Jude Medical Upgrades All Epic HF and Atlas+ HF Devices with V-V Timing Programmability
Business Wire, April 14, 2005
ST. PAUL, Minn. -- In an effort to provide important, cutting-edge technologies to even more heart failure patients, St. Jude Medical, Inc. (NYSE:STJ) announced today that it has received U.S. Food and Drug Administration (FDA) approval to activate V-V (ventricle to ventricle) timing in all models of its Epic(TM) HF and Atlas(R) HF CRT-Ds (cardiac resynchronization therapy defibrillators). Thousands of patients implanted with these devices now have the important therapeutic option of V-V timing programmability, which is designed to optimize the benefits of resynchronization pacing.
"Response from physicians has been so encouraging that we wanted to offer V-V timing programmability to a wider number of heart failure patients, including those who were originally implanted with device models that did not have the feature available," said Michael T. Rousseau, President of St. Jude Medical's US Division. "V-V timing allows physicians important flexibility to optimize therapy based on the needs of individual patients."
This upgrade is made possible by a programmer software enhancement, and can be enabled during a patient's regular visit with a clinician. The feature had previously been available only in certain models of the St. Jude Medical Epic(TM) HF and Atlas(R) HF CRT-Ds. St. Jude Medical is the only company with FDA approval for V-V timing in CRT defibrillators.
V-V timing refers to the delay between contraction of the left and right ventricles, compared with simultaneous pulses to both left and right ventricles. The V-V timing feature allows physicians to adjust the delay between ventricular outputs, as well as choose which chamber is paced first. Patients who do not respond to simultaneous pacing may benefit from the sequential timing offered by V-V programmability.
Any statements made regarding the Company'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 Financial Section of the Company's Annual Report to Shareholders for the fiscal year ended December 31, 2004 (see page 17). Actual results may differ materially from anticipated results.
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.
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