Japanese MHLW approves St. Jude Medical's AnalyST ICD with ST Monitoring device

St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced regulatory approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) of its AnalyST^™ 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 (called ST segments) to help physicians monitor for cardiac problems. This new monitoring capability may allow physicians to intervene earlier to help reduce patient risks. The AnalyST ICD is not approved for use in the United States.

“I look forward to accessing this new and valuable information for more insight into the condition of my ICD patients with ischemia or idiopathic VF, including Brugada syndrome.”

The AnalyST ICD with ST Monitoring is the industry's first device to continuously monitor specific changes in the heart's electrical system that can indicate conditions such as ischemia (which occurs when the flow of oxygenated blood to the heart muscle is obstructed). 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 as 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 provides ST segment monitoring reports via high-quality, intracardiac electrograms, as well as additional ST segment diagnostic reports," said Morio Shoda, M.D., Associate Professor, Department of Cardiology, Tokyo Women's Medical University. "I look forward to accessing this new and valuable information for more insight into the condition of my ICD patients with ischemia or idiopathic VF, including Brugada syndrome."

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.

In addition to the ST Monitoring diagnostic, the AnalyST ICD includes therapy-enhancing St. Jude Medical features, such as:

• DeFT Response® technology - which is designed to help devices meet the needs of patients who may have high or varying thresholds for the amount of energy required to defibrillate the heart. This enables the physician to tailor device therapy for individual patients, offering them added protection in the event of a life-threatening arrhythmia.
• VIP® (Ventricular Intrinsic Preference) algorithm - provides a delay in device stimulation of the lower chambers of the heart (ventricles) to allow the patient's own heart rhythm to prevail when possible. The VIP technology is designed to provide device stimulation only when needed, which has been shown to be better for patients' overall heart health.
• SenseAbility® technology - which is designed to optimize sensing to help protect against inappropriate shocks.
• Vibrating patient notifier - The industry's only notifier that gently vibrates - instead of issuing the standard audio alert - to notify patients if the device is not performing as designed; this can be especially beneficial for people with hearing loss.

An ICD delivers potentially life-saving therapy to the patient's heart through an insulated wire or lead. It is a small device implanted near the collarbone to treat potentially lethal, abnormally fast heart rhythms (ventricular tachycardias or VF), which often lead to sudden cardiac death. Idiopathic VF, which is ventricular fibrillation without a known cause, is particularly prevalent in Japan, especially as a result of Brugada syndrome (a genetic disorder that can result in sudden cardiac arrest).