Healthcare Industry News:  neuromodulation 

Devices Monitoring Cardiology

 News Release - June 17, 2010

St. Jude Medical Announces First Enrollment in Landmark Clinical Trial of Novel Heart Failure Management System

LAPTOP-HF trial will evaluate whether use of a physician-directed, patient self-management system, guided by left atrial pressure measurements, can improve outcomes in patients with heart failure

ST. PAUL, Minn.--(HSMN NewsFeed)--St. Jude Medical, Inc. (NYSE:STJ ), a global medical device company, today announced the first enrollment in its LAPTOP-HF (Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy) study. The goal of the LAPTOP-HF study is to demonstrate that the new investigational left atrial pressure (LAP) management system safely and effectively improves outcomes in patients with heart failure (HF). The system allows patients to adjust their HF medications daily based on a physician-directed prescription plan and their current LAP, similar to the manner in which diabetes patients manage their insulin therapy.

Clinicians commonly use the symptoms of HF, such as fatigue or shortness of breath, to determine a patient’s HF status and subsequent treatment; however, changes in HF symptoms are difficult to gauge and may be caused by other conditions. LAP is considered the “gold standard” for assessing HF status, providing the most objective measure of left-sided hemodynamics. Changes in LAP precede development of pulmonary edema (fluid in the lungs) and result in worsening HF symptoms.

The LAPTOP-HF trial is a 700 patient pivotal, randomized, controlled, prospective, multi-center clinical investigation to evaluate the safety and effectiveness of the LAP HF management system. Currently, there is no means of measuring LAP outside the hospital setting.

The first enrollment was performed by a multidisciplinary team including the Principal Investigators, Dr. Leway Chen, a heart failure specialist, and Dr. Spencer Rosero, a cardiac electrophysiologist, both from the University of Rochester Medical Center in Rochester, New York. Commenting on the trial, Dr. Chen said, “This system has the potential to bring left atrial pressure monitoring to the outpatient setting, which I believe will ultimately empower patients to take more control in the management of their condition.” Dr. Rosero said, “The initiation of this trial is an important step towards the real-time management of chronic diseases and improving the lives of those living with heart failure.”

Physician-directed, patient self-management, which has become standard in diabetes management, is a new approach for HF management. It may provide physicians the ability to better personalize and optimize HF management on the basis of daily, objective measures of a patient’s HF status. By providing patients with daily feedback on their LAP status and automated prescription instructions, it may also encourage self-management and treatment adherence in a more efficient manner than possible with traditional heart failure management approaches.

Recently published results of the HOMEOSTASIS feasibility clinical study suggest that use of outpatient LAP monitoring, with patient-managed therapy, could change current management of advanced heart failure, facilitate more optimal therapy and improve patient outcomes.

“If successful, this trial will provide physicians with a valuable tool to treat heart failure more efficiently and more effectively, providing patients with better quality of life and reducing burden on the health care system,” said Dr. Mark Carlson, chief medical officer and senior vice president of research and clinical affairs for the St. Jude Medical Cardiac Rhythm Management Division. “This is just one of the many technologies St. Jude Medical is focused on developing to improve physicians’ and patients’ ability to manage this chronic disease.”

About the LAPTOP-HF Trial

Patients participating in the LAPTOP-HF trial who receive the implantable sensor will be given a portable, handheld device that wirelessly retrieves the LAP measurement data from the implanted sensor. The system’s DynamicRx® feature then directs patients to adjust their medications based on the physician’s prescription plan.

The LAP management system includes the following components:

* A small, pacemaker-sized, stand-alone implantable LAP monitoring device, or a cardiac rhythm management (CRT/ICD) device with an integrated LAP monitoring feature

* A lead, or thin wire from the device to the heart, with an LAP sensor

* Patient Advisor Module (PAM®), a portable, wireless, handheld device that is used by the patient to check LAP status and that, through the DynamicRx feature, directs the patient to take specific medicines or make lifestyle adjustments based on the LAP measurement

The LAP management system is being studied under an investigational device exemption (IDE) from the U.S. Food and Drug Administration (FDA). It will be studied in NYHA Class III patients who have a history of ischemic or non-ischemic cardiomyopathy for at least six months and at least one HF hospitalization within the past 12 months. The trial will take place at up to 75 sites in the United States and additional sites outside the U.S. It will enroll approximately 700 patients in total, who will be monitored for several years. The primary effectiveness endpoint is a reduction in HF-related hospitalizations.

About Heart Failure

Over five million Americans have HF with 670,000 new cases diagnosed each year. Heart failure occurs when the heart is only able to pump enough blood to meet the body’s demands by elevating pressures within the heart. Significant HF progression over a period of days is known as acute decompensation and is often associated with substantially elevated LAP. High LAP directly forces excess fluid into the lungs causing congestive symptoms, most commonly breathlessness. Approximately 90% of patients admitted to a hospital for HF have pulmonary congestion related to elevated LAP. Episodes of pulmonary congestion have a high associated mortality and result in a downward spiral of progressive cardiac deterioration. The estimated direct and indirect cost of HF in the United States for 2009 was $37.2 billion.

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 sjm.com.

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 Quarterly Report on Form 10-Q for the fiscal quarter ended April 3, 2010. 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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