New System Utilizes Nonexcitatory Impulses

A new method known as Cardiac Contractility Modulation (CCM), in which nonexcitatory impulses are delivered to the heart during a period of time called the absolute refractory period (ARP), is used in the new Optimizer III system.
The system is designed to deliver electrical impulses to the heart for treatment of moderate to severe heart failure.
It consists of a programmable implantable pulse generator (IPG), a portable programmer, the Monita System, a charger and percutaneous pacemaker leads. The implantable pulse generator produces the CCM signals that are delivered to the heart through the pacemaker leads. The portable programmer allows medical personnel to customize the Optimizer signal parameters according to each patient's needs. The charger permits the patient to recharge the battery of the Optimizer III at home.
Vanderbilt University’s Medical Center is one of 40 centers nationwide to enroll patients in a trial called FIX-HF-5 (Fix Heart Failure 5), multicenter, prospective, randomized study to determine the efficacy and safety of the new pacing device. Vanderbilt will enroll up to 20 patients and follow them for up to a year. It is the first time the Optimizer III will be implanted in humans.