Impulse Dynamics has announced the publication of the FIX-HF-5C2 study in Circulation: Heart Failure. A press release reports that the study affirms the safety and efficacy of the company’s 2-lead version of the Optimizer system, which was approved by the FDA in October 2019.
The prospective, multicentre, single-arm study was designed to evaluate the performance, safety and efficacy of the 2-lead Optimizer system. The study, according to a press release, confirmed the 2-lead version of the device is just as effective at delivering cardiac contractility modulation (CCM) therapy as the 3-lead version and by eliminating the atrial lead, patients experienced significantly fewer device-related complications when compared to the 3-lead version. Patients that received the 2-lead version had a significantly greater improvement in exercise capacity (as measured by peak VO2) and functional status (as measured by New York Heart Association functional class) when compared to the FIX-HF-5C control group. Additionally, 15% of the patients enrolled in the FIX-HF-5C2 study had atrial fibrillation.
Phi Wiegn (Dallas VA Medical Center, Dallas, USA), lead author of the publication, says: “The 2-lead version of the Optimizer system is an important evolution that reduces lead-related complications and simplifies the implantation procedure. CCM is a truly unique device therapy that I can offer to a large group of heart failure patients to make them feel better when standard medical therapy no longer does.”
The FIX-HF-5C2 study was a confirmatory extension of the FIX-HF-5C randomized study and enrolled heart failure patients from eight medical centres in the USA and Germany. Patients were evaluated at baseline and again at 12 and 24 weeks after implantation.
Ishu Rao, medical director for Impulse Dynamics, comments: “The publication of this data confirms that the 2-lead device is a significant advancement for how we can provide CCM therapy to heart failure patients. Notably, the data shows that CCM therapy has a substantial positive impact on a patient’s functional capacity over time versus standard medical care alone. There has been tremendous excitement from patients and providers for the 2-lead Optimizer system and we look forward to continuing to expand the adoption of this breakthrough treatment option.”
The press release states that CCM therapy may be an appropriate treatment option for the approximately 70% NYHA Class III heart failure patients who remain symptomatic despite guideline-directed medical therapy.