Impulse Dynamics Launches Phase II Heart Failure Study

Impulse Dynamics has announced that it has begun a Phase II clinical study to investigate the safety and effectiveness of a new implantable pulse generator called the OPTIMIZER III and that the first patient in the Phase II study was successfully implanted at St. Joseph's Hospital in Atlanta.

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 Class III or Class IV heart failure patients at up to 50 U.S. sites.

Based on a new method known as Cardiac Contractility Modulation, the OPTIMIZER delivers nonexcitatory impulses to the heart during a period of time called the absolute refractory period. These signals do not initiate the heart to beat, but are intended to modify heart cell function for the treatment of heart failure. This phase of the trial is a follow-on to Phase I, which completed enrollment in December 2004 and included 50 patients implanted with an OPTIMIZER System.