Healthcare Industry News:  Cardiac Resynchronization Therapy 

Devices Cardiology Regulatory

 News Release - June 21, 2011

St. Jude Medical Announces Japanese Launch of Smaller, Higher Power ICD and CRT-D Devices

New products help ensure effective therapy delivery even for patients with high defibrillation thresholds

ST. PAUL, Minn.--(Healthcare Sales & Marketing Network)-- St. Jude Medical, Inc. (NYSE:STJ ) today announced regulatory approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) and the launch of the Fortify™ ST implantable cardioverter defibrillators (ICD) and Unify™ Cardiac Resynchronization Therapy defibrillator (CRT-D). The reduced footprint of these new devices makes them the smallest available in the industry.

The Unify CRT-D and Fortify ST ICD feature advanced battery technology and circuitry that allow for a smaller device, with more energy capacity and rapid charge times, all while increasing device longevity. The energy capability of a device is particularly important for patients who have an enlarged heart, low ejection-fraction, advanced heart failure or previously demonstrated a high defibrillation threshold (the amount of energy required to shock the heart back to a normal rhythm). These devices feature 40J of delivered energy (45J stored) – the highest energy level available in the industry – helping to ensure that therapy will be successful for those patients who require a higher energy shock for defibrillation.

Because of the devices’ narrower shape, physicians can implant them using a shorter incision, leading to less time spent closing the incision and a smaller scar for the patient. The company’s DF4 lead connector system further streamlines the procedure by reducing the number of connections between the defibrillation lead and the device, which can improve patient comfort by reducing the bulk of wires in the patient’s chest.

“The Unify and Fortify ST devices were designed to address many of the clinical issues facing our customers, and at the same time reduce the size to make them more comfortable for patients,” said Eric S. Fain, M.D., president of the St. Jude Medical Cardiac Rhythm Management Division. “We are happy to offer devices in Japan with the industry’s smallest footprint that will improve disease management of cardiac conditions.”

The Unify CRT-D and Fortify ST ICD also incorporate the new CorVue™ monitoring algorithm. This new feature alerts physicians to variations in thoracic impedance, a measurement that helps physicians better understand a patient’s heart failure status. The algorithm continuously monitors thoracic impedance as a surrogate for fluid retention in multiple vectors, providing information that may be used to index the level of heart failure.

The devices also feature the company’s ShockGuard technology, which is designed to reduce inappropriate and unnecessary shocks for patients. The programming in ShockGuard discriminates between rhythms that require defibrillation therapy and those that do not. Additionally, the advanced sensing technology designed to avoid sensing unwanted signals (T-waves) and offer more anti-tachycardia pacing options, which can convert many fast ventricular arrhythmias painlessly and avoid the need for high voltage shocks. A retrospective analysis of the Advancements in ICD Therapy (ACT) registry, which enrolled more than 5,000 patients and allowed programming at the physician's discretion, demonstrated that at the end of one year, 98.5 percent of patients with the ShockGuard programming would be free of inappropriate shocks.

“The size and shape of the Unify and Fortify ST devices are significantly smaller than that of the current devices, which is truly helpful as patients in Japan tend to be smaller than those in Western countries,” said Dr. Hideo Okamura from the National Cerebral and Cardiovascular Center in Osaka, Japan. “Although smaller, these devices have an extended longevity and a stronger output of energy for shock therapy. Taken together, I believe that these enhanced features will improve patient care.”

The Fortify ST ICD features St. Jude Medical's first-to-market ST segment monitoring diagnostic algorithm, which can add important information to assist in medical decision making and accelerate patient care. The Fortify ST ICD continuously monitors for specific changes in the ST segment of the electrocardiogram that can indicate the onset of serious conditions such as ischemia (which occurs when blood flow/oxygen to the heart muscle is obstructed).

Dr. Takashi Noda from the National Cerebral and Cardiovascular Center added, “It is very important for us as physicians to utilize as many indications and diagnostic data as we can for each heart failure patient therapy and follow up. In addition to the additional data provided with the CorVue, the new devices also have new features and settings that help to reduce inappropriate and unnecessary shock therapy.”

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 sporadic diagnostic reports when the patient is in the clinic or hospital.

An ICD is an advanced implantable device that treats potentially lethal, abnormally fast heart rhythms (ventricular tachycardias or ventricular fibrillation), which often lead to sudden cardiac death (SCD). Approximately 325,000 people per year in the U.S. die suddenly of SCD.

A CRT-D device resynchronizes the beating of the heart's lower chambers (ventricles), which often beat out of sync in heart failure patients, and provides back up treatment for SCD, which is a risk factor associated with certain types of heart failure. Studies have shown that CRT (Cardiac Resynchronization Therapy) can improve the quality of life for many patients with heart failure, a progressive condition in which the heart weakens and loses its ability to pump an adequate supply of blood.

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. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit

Forward-Looking Statements

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 January 1, 2011 and Quarterly Report on Form 10-Q for the fiscal quarter ended April 2, 2011. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.

Source: St. Jude Medical

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