Impulse Dynamics, based in Mt. Laurel, New Jersey, has developed the Optimizer system, a device designed to improve myocardial contractility in patients with heart failure. The system is intended to improve the quality of life of heart failure patients by reducing the severity of their symptoms.
At present, many heart failure patients have few options in terms of effective treatments to reduce and control their symptoms. Medication can help certain patients, but some still experience unacceptable symptoms. Pacemakers, which correct the heart’s rhythm, are beneficial for some, but not all patients, and they do not increase the effort the heart puts into pumping blood around the body.
The Optimizer is an implantable device that delivers electrical impulses to the heart specifically to improve myocardial contractility, using a technique known as Cardiac Contractility Modulation (CCM). The device connects to the heart through two leads that deliver electrical impulses at a specific time during the heart cycle, increasing the systolic contraction of the myocardium.
Increasing cardiac motility can enhance quality of life for heart failure patients and increase their ability to perform everyday activities, such as walking. Approved by the FDA in 2019, the device is now set to undergo a post-approval study to further substantiate safety and efficacy in heart failure patients.
See a video about the device and technique below.
Impulse Dynamics recently raised $80 million to commercialize the Optimizer, and has appointed Ishu Rao, M.D., as its new medical director. Medgadget had the opportunity to talk to Dr. Rao about the Optimizer and CCM.
Conn Hastings, Medgadget: Please give us an overview of heart failure and the unmet needs of such patients.
Ishu Rao, Impulse Dynamics: Heart failure is a condition in which the heart slowly weakens and is unable to pump with the force required to supply oxygen-rich blood to meet the body’s needs. Heart failure affects 6.5 million Americans, and that number is expected to increase to 8 million by 2030. The reason this number is so alarming is because the symptoms of heart failure are truly debilitating and reduce the overall quality of life for the patient. Breathlessness, fatigue, confusion and swelling in the legs are a few examples of symptoms that make everyday activities challenging for heart failure patients. CCMTM, or cardiac contractility modulation therapy, delivered by Impulse Dynamics’ Optimizer® is the first and only treatment of its kind designed to improve contraction of the heart, allowing more oxygen-rich blood to reach the body. The therapy is a new and effective way to address the unmet needs of heart failure patients.
Medgadget: What types of treatments are currently available for heart failure patients?
Ishu Rao: Traditional heart failure treatment options primarily rely on medication to slow the progression of the disease and to manage symptoms, but as heart failure progresses these treatments lose their effectiveness and the quality of life for these patients continues to decline.
Cardiac resynchronization therapy (CRT) is an option for a small proportion of heart failure patients to improve the heart’s rhythm which may help to improve overall heart function. Even if a patient is indicated for CRT, the delivery and goal of the therapy fundamentally differs from CCM therapy.
Defibrillator implantation may also be appropriate for some patients, but these devices are intended to restart the heart if it stops beating and do not provide the type of symptomatic therapeutic effect that CCM therapy does. If a patient has a defibrillator, they may still be eligible for CCM therapy.
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. There are millions of people in the world that fit this criterion, with about 1.25 million in the US alone.
Medgadget: How does the Optimizer work, and how does it differ from other electrophysiological treatments for heart failure?
Ishu Rao: The Optimizer delivers CCM therapy, the company’s proprietary technology, to the heart. 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 approach was proven to be safe and effective in numerous clinical studies, including several randomized controlled trials, and the results have been published in over 80 articles appearing in leading medical journals.
From the outside in, the Optimizer looks like a pacemaker, but that’s where the similarities end. A pacemaker is designed to make the muscle react and contract. Optimizer is delivering therapy designed to modulate the strength of the cardiac muscle contraction rather than its rhythm. There are fundamental differences between the two devices, a pacemaker will deliver less than one volt, the Optimizer delivers seven and a half volts. A pacemaker delivers therapy for half a millisecond, the Optimizer delivers therapy for 20 milliseconds at a time. Additionally, the Optimizer delivers therapy for one hour at a time for a total of five hours a day rather than continuously like a pacemaker does. The therapy is completely unique – there is no other therapy like it.
Pacemakers may be suitable for a small portion of heart failure patients, whereas CCM therapy through the Optimizer system is an effective treatment option for a much larger percentage of heart failure patients.
Medgadget: What types of heart failure patients is the Optimizer suitable for?
Ishu Rao: Optimizer is suitable for heart failure patients who remain symptomatic despite receiving guideline-directed medical therapy, who are in normal sinus rhythm and who do not qualify for a heart pump or cardiac resynchronization therapy. CCM therapy is suitable for patients with a left ventricular ejection fraction ranging from 25% to 45% and is indicated to improve New York Heart Assn. (NYHA) functional status, 6-minute hall walk distance and quality of life of NYHA Class III heart failure patients.
Medgadget: Please give us an overview of the upcoming safety and efficacy trial of the system.
Ishu Rao: Impulse Dynamics recently announced the first enrollment in its post-approval study that will evaluate the real-world evidence of the therapy’s safety and efficacy, which was approved by the FDA in March 2019. The study will take place over three years and will enroll up to 620 patients from heart centers across the United States. Efficacy endpoints include improvements in quality of life (MLWHFQ), NYHA classification, left ventricular ejection fraction and end-systolic volume. Safety endpoints include device- or procedure-related complications, and an assessment of all-cause mortality. Much like a current registry underway in Germany that has already enrolled more than 1,500 patients, this study will continue to strengthen our global clinical portfolio of evidence validating the benefits of CCM therapy.
We are also preparing additional studies that will help further demonstrate the efficacy of this new therapeutic category for treating heart failure. CCM therapy has the potential to become a new standard of care for treating heart failure, and our goal is to continue building the clinical evidence to demonstrate that to the cardiology community.
Medgadget: What types of improvements in symptoms can patients expect once they are fitted with the Optimizer?
Ishu Rao: Patients and their caregivers often feel hopeless about their treatment options as heart failure progresses, and their physical condition deteriorates. This is why CCM therapy represents a tremendous advancement in how health care providers are able to care for these patients.
Patients who successfully respond to CCM therapy can expect to have more energy and simply feel better and less lethargic. For some patients, improvements may begin as soon as the first few days following the implantation procedure and most see improvements in a matter of weeks or months. When providers are treating heart failure patients there is a significant focus on improving quality of life, and that means improving the often-debilitating symptoms associated with the disease. CCM therapy is a breakthrough approach to treating heart failure that is proven to improve quality of life for suitable patients. With more oxygen-rich blood reaching the body, patients can see a reduction in symptoms such as breathlessness, fatigue, confusion and swelling in the legs. Ultimately, we’re giving patients hope that they can get back to living the life they love.
Flashbacks: Optimizer III: Cardiac Contractility Modulation Therapy for CHF; Impulse Dynamics Unveils CE-Marked OPTIMIZER IVs System for Treatment of CHF; First Cardiac Contractility Modulation Device Approved by FDA