|St. Jude Medical Announces European Approval and Initial Implant of First Device to Continuously Monitor Electrical Changes That Signal Potential Cardiac Problems|
First-of-its-kind device helps to detect cardiac changes, giving physicians unprecedented insight into heart-related events and patient risks
ST. PAUL, Minn.--(BUSINESS WIRE)--Dec. 3, 2008--St. Jude Medical, Inc. (NYSE:STJ) today announced European CE Mark approval of its AnalyST(TM) implantable cardioverter defibrillator (ICD) with ST Monitoring, a revolutionary device that not only provides life-saving therapy for dangerously fast heart rhythms, but also continuously monitors electrical changes between heartbeats (called ST segments) to help physicians monitor disease progression. This new monitoring capability may give physicians earlier and more accurate insight into cardiac problems and may help reduce patient risks. The device will be introduced today at the International Symposium on Progress in Clinical Pacing, in Rome.
The AnalyST ICD with ST Monitoring is the industry's first device to continuously monitor specific changes in the heart's electrical system which can indicate conditions such as ischemia (which occurs when the flow of oxygenated blood to the heart muscle is obstructed). Changes in the ST segment also have been linked to significant clinical events such as heart attacks. Learning about these conditions earlier may lead to more timely diagnosis and therapy for patients, and possibly improve patient prognosis.
With the device's monitoring diagnostic, small changes in ST segment are continuously and precisely recorded and plotted, and then retrieved for the physician to review during patient follow-up visits. Because many cardiac episodes are transient in nature, continuous ST Monitoring is important because it gives physicians more comprehensive ST segment information over time rather than a sporadic, hit-or-miss diagnostic report. In the near future, physicians also will be able to monitor patients' ST segment changes via remote transmissions from the St. Jude Medical Merlin@home transmitter (a wireless remote monitoring system in patients' homes), and will receive alerts through the Merlin.net patient care network.
"The AnalyST ICD is the only implantable device that can provide me with ST segment monitoring reports via high-quality, intracardiac electrograms, as well as additional ST segment diagnostic reports," said Professor Christian Hamm, Ph.D., from the Kerckhoff Klinik who implanted the first AnalyST ICD in Bad Nauheim, Germany. "This device provides me with new and valuable information about my patients' ST segments that is otherwise not available and helps me deliver better and more timely care for my patients with arrhythmias and coronary artery disease."
The surface electrocardiogram (ECG) has been the gold standard for diagnosing risk for heart tissue damage and arrhythmias. However, surface ECG has limitations: it provides only a few seconds of information at a time, it cannot be used to continuously monitor the patient over a long period, and it is susceptible to poor signal quality. The AnalyST ICD not only provides continuous information, but it also provides high-fidelity electrograms from the inside of the heart for accurate detection of a wide range of ST segment changes. When combined with other data available to physicians, ST segment information helps physicians make better-informed, evidence-based decisions for patient care.
"Unlike a diagnostic surface ECG, the AnalyST ICD continuously monitors and reports ST-segment changes over time while the patient goes about their normal daily activities," said Eric S. Fain, M.D., president of the St. Jude Medical Cardiac Rhythm Management Division. "This device gives physicians unparalleled insight into a patient's condition while potentially improving care for patients who may be at risk for dangerous heart-related conditions."
In addition to the ST Monitoring diagnostic, the AnalyST ICD includes therapy enhancing St. Jude Medical features, such as:
An ICD is a small device implanted near the collarbone to treat potentially lethal, abnormally fast heart rhythms (ventricular tachycardias or ventricular fibrillation), which often lead to sudden cardiac death. An ICD delivers potentially life-saving therapy from the device to the patient's heart through an insulated wire or lead.
About St. Jude Medical
St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. Headquartered in St. Paul, Minn., St. Jude Medical employs more than 13,000 people worldwide and has five major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiac surgery, cardiology and neuromodulation. For more information, please visit www.sjm.com.
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including potential clinical successes, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings and market shares. The statements made by the Company are based upon management's current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the Company's control and the risk factors and other cautionary statements described in the Company's filings with the SEC, including those described in the Risk Factors and Cautionary Statements sections of the Company's Annual Report on Form 10-K for the fiscal year ended December 29, 2007 and Quarterly Report on Form 10-Q for the fiscal quarter ended September 27, 2008. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.
CONTACT: St. Jude Medical, Inc.