Heart device
As part of a national clinical trial, St. Mary Medical Center recently implanted the Optimizer® Smart implantable device, designed to deliver electrical impulses to the heart so it can contract more effectively and efficiently using Cardiac Contractility Modulation (CCM™). St. Mary is the first hospital in Bucks County, and one of the first in the region, to implant the Optimizer® Smart device through the FIX-HF-5CA clinical trial.
The purpose of the FIX-HF-5CA clinical trial is to allow continued access to the Optimizer Smart System until the PMA order has been issued by the FDA. The Optimizer® Smart system has been developed to improve heart failure symptoms in patients with moderate to severe heart failure (NYHA Class III-IV) who have symptoms despite optimal medical therapy.
Heart failure affects approximately 5.8 million Americans. Every year about one in every 100 people over age 65 is diagnosed with heart failure. CHF occurs when the heart is unable to adequately pump a sufficient amount of blood to meet the needs of the body as a result of a weakened heart with poor pumping strength. Heart failure is most often the result of damage to the heart muscle following a heart attack, untreated coronary artery disease (CAD) and/or persistent high blood pressure.
The Optimizer® Smart device is small enough to fit in the palm of your hand. It delivers electrical CCM™ signals to the heart that increase the pumping action of the heart without influencing the heart rhythm. Rather, CCM™ is thought to promotes increased expression and improved function of certain proteins in the heart muscle that play a key role in the contractility of the heart muscle cells. The Optimizer® Smart is compatible with other cardiac devices, such as an ICD or pacemaker system.
“This study is one of the first steps in helping us determine if this device will be another viable treatment option we can offer patients with heart failure,” says Electrophysiologist and St. Mary’s Heath Saltzman, M.D., Principal Investigator. “Our ultimate goal is to give our patients with heart failure a better quality-of-life, and we’re hopeful this device can deliver on that promise.”
The results of the FIX-HF-5CA study will be released upon completion of the trial. For additional information regarding the FIX-HF-5CA clinical trial at St. Mary Medical Center, contact Marci Petrino, RN, MSN, CCRP at 215-710-4586.