Investigational Study Evaluating Use of New Implantable Pulse Generator, Optimizerâ„¢ System, Looking for Heart Failure Patients

Filed in archive Cases , Diagnostics , Investigational , Studies on November 7, 2006

Arizona Arrhythmia Consultants are now enrolling patients in a clinical study to investigate the safety and effectiveness of a new implantable pulse generator called the Optimizerâ„¢.

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 and is sponsored by Impulse Dynamics (USA) Inc., a New York-based specialty medical device company --the maker of the Optimizerâ„¢ System.

According to Dr. Thomas Mattioni, principal investigator of the study:

"The Optimizer System is an exciting technology with the potential to treat patients with Class III or Class IV heart failure. We have already begun enrolling patients in the 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, afflicting over 5 million Americans and an estimated 15 million patients worldwide, is a disease caused by weak or damaged heart muscle that is unable to pump enough blood throughout the body.

The Optimizerâ„¢ System, designed to deliver electrical impulses to the heart for treatment of moderate to severe heart failure, when and if proven safe and effective has the potential to help treat heart failure in a large number of patients.

Find more details from the press release.

For more info on patient enrolment, contact:

Erich A. Sandoval
Lazar Partners LTD. on behalf of Arizona Arrhythmia Consultants
Tel. 212-867-1773
E-mail: esandoval@lazarpartners.com