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Southern California Heart Centers Now Enrolling Heart Failure Patients for New Implantable Cardiac Device Trial

Posted on: Monday, 19 September 2005, 12:00 CDT

SAN GABRIEL, Calif., Sept. 19 /PRNewswire/ -- Southern California Heart Centers today announced it is enrolling patients in a clinical study to investigate the safety and effectiveness of a new implantable pulse generator called the OPTIMIZER(TM). The OPTIMIZER System is designed to deliver electrical impulses to the heart for treatment of moderate to severe heart failure. This study of the OPTIMIZER System is sponsored by Impulse Dynamics (USA) Inc., a specialty medical device company located in New York and a wholly-owned subsidiary of Impulse Dynamics N.V.

Heart failure is a disease caused by weak or damaged heart muscle that is unable to pump enough blood throughout the body. If proven safe and effective, the OPTIMIZER System has the potential to help treat heart failure in a large number of patients.

The investigational study, called FIX-HF-5 (Fix Heart Failure 5), is designed to investigate the effects of the OPTIMIZER System in approximately 400 New York Heart Association (NYHA) Class III or Class IV heart failure patients at up to 50 U.S. sites."

The OPTIMIZER System is technology with the potential to treat patients with Class III or Class IV heart failure," said Dr. Stanley Lau, chief cardiologist at Southern California Heart Centers. "We have already begun enrolling patients in a FIX-HF-5 Study to evaluate the safety and effectiveness of the OPTIMIZER System. We look forward to completing new patient enrollment in order to fully assess the potential of this device to meet the needs of moderate to severe heart failure patients."

Heart failure is a disease that afflicts over 5 million Americans and an estimated 15 million patients worldwide. It is one of the most common causes of hospitalization and a growing and costly burden to the healthcare system. It is estimated that the U.S. healthcare system will spend a projected $28.8 billion on caring for heart failure patients in 2005.

All patients who qualify for the study will receive study related treatment, exams and tests, all at no cost, and may be reimbursed for time and travel to the site conveniently located just off of the freeway in San Gabriel, just east of downtown Los Angeles. Participants do not need medical insurance. For more information and/or to find out if you or someone you know may qualify, call toll free 1-888-308-1380, during normal business hours.

Impulse Dynamics (USA) Inc., the sponsor of the FIX-HF-5 study, is located in New York, with corporate headquarters of Impulse Dynamics N.V. in the Netherlands Antilles. OPTIMIZER(TM) is a trademark of Impulse Dynamics N.V. For more information, please visit http://www.impulse-dynamics.com/.

Established in 1999, Southern California Heart Centers (SCHC) is a medical corporation specializing in providing state-of-the-art cardiac care. Located in San Gabriel, California, SCHC offers full cardio-pulmonary physiology assessment, treatment of atherosclerotic heart disease, valvular disease, congenital heart disease, peripheral vascular disease and rhythm disorders. SCHC is distinguished by being one of the first and very few ICAEL

(Inter-societal Commission for the Accreditation of echocardiography laboratories) ACCREDITED echo lab in the Southland.

Southern California Heart Centers

CONTACT: Sandra Levy, +1-562-841-2421, slevy@charter.net; or LindaKaplan, +1-714-538-5678, linda@kaplancommunicationsgroup, both of KaplanCommunications Group

Web site: http://www.impulse-dynamics.com/

Source: PRNewswire

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