Study Affirms Safety of Two-Lead Optimizer System

Impulse Dynamics, a medical device company dedicated to improving the lives of heart failure patients, announced the publication of the FIX-HF-5C2 study, which affirms the safety and efficacy of the company’s 2-lead version of the Optimizer system. The system was approved by the U.S. Food and Drug Administration (FDA) in October 2019.
 
The prospective, multicenter, single-arm study was designed to evaluate the performance, safety and efficacy of the 2-lead Optimizer system. The study confirmed the 2-lead version of the device is just as effective at delivering CCM (cardiac contractility modulation) 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 percent of the patients enrolled in the FIX-HF-5C2 study had atrial fibrillation.
 
“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,” said Ishu Rao, M.D., medical director for Impulse Dynamics. “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 FIX-HF-5C2 study was a confirmatory extension of the FIX-HF-5C randomized study and enrolled heart failure patients from eight medical centers in the United States and Germany. Patients were evaluated at baseline and again at 12 and 24 weeks after implantation.
 
“The 2-lead version of the Optimizer system is an important evolution that reduces lead-related complications and simplifies the implantation procedure,” said Phi Wiegn, M.D., of the Dallas VA Medical Center and lead author of the publication. “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.”
 
CCM therapy may be an appropriate treatment option for the approximately 70 percent of NYHA Class III heart failure patients who remain symptomatic despite guideline-directed medical therapy.¹
 
CCM therapy, delivered by the Optimizer system, is a breakthrough approach for treating heart failure that is proven to improve quality of life for suitable patients.¹ The therapy is the first therapy of its kind designed to improve contraction of the heart, allowing more oxygen-rich blood to reach the body.¹ CCM therapy delivers precisely timed electrical pulses to the heart during the absolute refractory period of the beating cycle, just after the heart contracts. The Optimizer system was granted Breakthrough Device designation by the FDA and is the first and only FDA-approved device in the United States or elsewhere for the delivery of CCM therapy.
 
Heart failure, a condition in which the heart slowly weakens and is not able to adequately supply oxygen-rich blood, affects an estimated 6.5 million Americans and nearly 26 million people worldwide.² By 2030, it is expected to affect 8 million Americans.³ Heart failure patients experience debilitating symptoms, including breathlessness, fatigue, confusion and swelling in the legs that make everyday activities challenging and significantly diminish their quality of life. Nearly 50 percent of people with heart failure die within five years of being diagnosed.³ The annual cost for healthcare services, medications and lost working days in the United States is estimated to reach $70 billion by 2030.³
 
References
¹ Abraham WT, Kuck KH, Goldsmith RL, et al. A randomized controlled trial to evaluate the safety and efficacy of cardiac contractility modulation. JACC Heart Failure. 6(10), 874-883 (2018).
² Savarese G, Lund LH. Global Public Health Burden of Heart Failure. Card Fail Rev. 2017 Apr; 3(1): 7–11.
³ Benjamin E, Blaha M, Chiuve S, et al. Heart Disease and Stroke Statistics—2017 Update: A Report From the American Heart Association. Circulation. 2017;135:e146–e603