Healthcare Industry News:  Cardiac Resynchronization Therapy 

Devices Cardiology FDA

 News Release - May 11, 2009

St. Jude Medical Announces FDA Approval of Current Plus ICD and Promote Plus CRT-D Devices to Provide Therapy for Life-Threatening Arrhythmias and Heart Failure

ST. PAUL, Minn. -- (HSMN NewsFeed)--St. Jude Medical, Inc. (NYSE:STJ ) today announced U.S. Food and Drug Administration (FDA) approval of the Promote® Plus Cardiac Resynchronization Therapy defibrillator (CRT-D) and Current® Plus implantable cardioverter defibrillators (ICDs), designed with TailoredTherapy™ features that give physicians more options for customizing therapy for patients with potentially lethal heart arrhythmias and heart failure.

“There is no ‘text book’ patient. Each person presents a unique anatomy, disease state and response to therapy,” said Eric S. Fain, M.D., president of the St. Jude Medical Cardiac Rhythm Management Division. “With the feature set available in the Promote Plus and Current Plus devices, physicians can customize programming to ensure each patient is receiving therapy that is appropriate for his or her individual condition.”

The Promote Plus CRT-D and Current Plus ICDs also offer a smoother header configuration designed to offer better patient comfort and improve visibility at the connector site, where the thin wire (called a lead) that delivers the electricity from the device to the heart is connected.

To better assist physicians in accurately diagnosing and managing patients with fast rates in the heart’s upper chambers (atria), the Promote Plus CRT-D and Current Plus ICDs also include a new atrial tachycardia/atrial fibrillation (AT/AF) Alert feature. This feature is designed to notify physicians when a rapid atrial rate exceeds a programmed value and occurs over an extended time period. These devices can also be programmed to notify the patient through a unique vibratory alert that has been clinically proven more effective than audible alerts.1 Additionally, the devices have the ability to inform the patient’s clinic through the St. Jude Medical Merlin@home® transmitter and™ Patient Care Network (PCN). These features allow the physician to better manage patients’ atrial arrhythmias, such as AF.

The Promote Plus CRT-D and Current Plus ICDs are built on the St. Jude Medical consolidated hardware and software “Unity” device platform and include the company’s advanced safety features and algorithms for better patient management. These include improved lead monitoring capabilities – including daily checks of all pacing and shock configurations – that provide added patient safety.

TailoredTherapy features in these devices include:

  • QuickOpt® timing cycle optimization - a programmer-based optimization method that is proprietary to St. Jude Medical that is used with CRT-Ds, CRT-Ps (Cardiac Resynchronization Therapy pacemakers) and ICDs to help physicians quickly program the device's timing cycles – in about 90 seconds - to help deliver optimal therapy to patients
  • DeFT Response® technology - designed to help devices meet the needs of patients with high or varying defibrillation thresholds, helping physicians to ensure appropriate delivery of life-saving therapy
  • 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 - designed to enable physicians to program the device to more accurately sense abnormal heart rhythms, thereby protecting the patient from receiving inappropriate shocks

An ICD is a small device implanted in the chest to treat potentially lethal, abnormally fast heart rhythms (ventricular tachycardias or ventricular fibrillation), which often lead to sudden cardiac death (SCD). Nearly 1,000 people every day and more than 350,000 every year in the U.S. die from SCD. An ICD delivers potentially life-saving therapy from the device to the patient's heart through an insulated wire or lead.

Cardiac Resynchronization Therapy - delivered in an ICD or a pacemaker - resynchronizes the beating of the heart's lower chambers (ventricles), which often beat out of sync in heart failure patients. Studies have shown that CRT 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 5 million Americans suffer from heart failure, with 550,000 new cases diagnosed every year, according to the American Heart Association.

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 approximately 14,000 people worldwide 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 3, 2009. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.

1 Bennett MT et al. The ICD patient alert is potentially an unreliable ICD warning feature. Presented at the Canadian Cardiovascular Congress, Toronto, Ontario, October 26, 2008.

Source: St. Jude Medical

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