Impulse Dynamics meets endpoints in Optimizer Smart trial
Data from a study of the Optimizer Smart device made by Impulse Dynamics showed that it holds promise for a previously untreatable group of heart failure patients.
Results from the Fix HF 5C study, presented by Dr. William Abraham of Ohio State University’s Wexner Medical Center, showed that patients with moderate ejection fractions who are not sick enough to warrant left ventricular assist devices or heart transplants but not well enough to go untreated could benefit significantly from the Optimizer Smart’s cardiac contractility modulation technology. The technology uses non-excitatory electrical pulses to remodel the myocardium to increase the heart’s efficiency.
“The reason why this is so important is that it promises to meet a very large unmet need in the management of heart failure,” Abraham said.
The 120-patient Fix HF 5C trial, of heart failure patients with ejection franctions of 25% to 45%, showed that the Optimizer Smart therapy significantly improved exercise capacity as measured by volume oxygen (VO2), meeting its primary efficacy endpoint. The therapy also significantly improved quality-of-life and functional status measures, a secondary efficacy endpoint, and hit its primary safety endpoint for device/ procedure-related events at 10.3%.
The clinical effects were larger in patients with ejection fractions of 35% to 45%, Abraham said.
“This really is a population of patients in which few, if any, evidence-based therapies exist,” he said.
“It’s an elegant study,” added Dr. Jagmeet Singh of the Mass. General Hospital, who presented data from another study. “It makes a good case for going ahead with the device.”