Cardiomedics has announced that the company's clinical study of its cardiac device shows that the product reduces heart failure mortality by 90 percent, along with an 87.5 percent drop in the number of hospitalizations.
The study was conducted at six clinical sites in the U.S. and employed Cardiomedics' CardiAssist External Counter Pulsation (ECP) System and new Graduated Pressure Regimen in the treatment of 127 New York Heart Association Class II, III and IV congestive heart failure (CHF) patients.
The CardiAssist ECP System uses a series of cuffs fastened with Velcro around the patient's calves, thighs and buttocks. The cuffs are sequentially inflated, synchronized with the patient's electrocardiogram, forcing blood up the veins and arteries to the heart between heartbeats, significantly increasing perfusion of the heart muscle.
The patients were divided into three groups depending on their diastolic to systolic pressure ratio (D/S ratio), resulting from the amount of pressure applied during the ECP therapy. Under Cardiomedics' new Regimen, the D/S ratios are gradually increased over the 35-hour ECP treatment program (one hour per day, five days a week for seven weeks).
In the 54 CHF patients of the low D/S ratio group, in the year following ECP therapy, mortality was only 1.85 percent, a statistically significant reduction from mortality of 7.69 percent in the 39 patients of the middle D/S ratio group and mortality of 8.82 percent in the 34 patients in the high D/S ratio group.