Impulse Dynamics touts improved exercise tolerance, quality of life with CCM HF therapy
Impulse Dynamics this week released results from a trial of its Cardiac Contractility Modulation therapy for heart failure, touting that the study met its primary and secondary safety endpoints with noted improvements in exercise tolerance and quality of life.
Results were presented at the annual meeting of the Heart Rhythm Society in Boston and published in the JACC: Heart Failure Journal.
The Orangeburg, N.Y.-based company’s CCM is designed to deliver electrical signals to the heart to reduce symptoms and improve exercise tolerance in heart failure patients. The study of the device aimed to confirm a subgroup analysis from a prior trial which showed that the system could improve exercise tolerance and quality of life in NYHA class III and IV patients with ejection fractions between 25% and 45% and a QRS of less than 130ms.
Results from the study affirmed those from a previous study of the device, and met safety and effectiveness parameters, the company said. Data indicated that patients receiving CCM treatment showed significantly better exercise tolerance and quality of life and a statistically significant reduction in heart failure hospitalizations when compared to the control group cohort.
Clinical effectiveness reported in the trial was greater in patients with ejection fraction rates equal to or greater than 35%, the company said.
“The results of the FIX-HF-5C study exceeded my expectations by not only confirming the benefits of CCM on important patient-centered endpoints such as exercise capacity and quality of life, but also in demonstrating the potential for CCM to reduce heart failure morbidity and mortality. These findings support the use of CCM as a breakthrough therapy for heart failure patients with moderately reduced left ventricular systolic function and narrow QRS durations, who currently have no other options for improvement,” Dr. William Abraham of The Ohio State University Wexner Medical Center said in a prepared statement.
“I would like to thank the FIX-HF-5C Study Investigators and the Impulse Dynamics’ team for completing this important study with its very encouraging results. We anticipate submission of the final PMA module to the U.S. FDA in June 2018,” CEO Dr. Simos Kedikoglou said in a press release.