Heart failure is one of the most common complications of cardiovascular conditions. In the United States, about 6.2 million adults have heart failure. C.D.C. projects that the number will continue to rise as the prevalence of cardiovascular diseases explode in the country.
Though heart failure progressively gets worse over time, some treatments can slow down the worsening of the condition. A combination of lifestyle changes and medications can slow disease progression and help patients live longer.
Unfortunately, not all patients react positively. Many experience side effects while others have worsening symptoms, causing a decline in daily activities. In time, even those who responded positively find their medications are no longer effective, leaving device therapies as the only option.
This poses a dilemma for patients under the NYHA Class ll or above heart failure with normal QRS duration. They are not eligible for cardiac resynchronization therapy or CRT, but their medication has a minimal effect on their symptoms.
Impulse Dynamics offers a new therapy designed to alleviate symptoms and improve the quality of life for HF patients.
Impulse Dynamics is a medical device company focused on delivering innovative solutions for treating chronic heart failure (CHF).
Based in Marlton, New Jersey, the company has pioneered cardiac contractility modulation therapy delivered through the Optimizer® CCM® therapy system. This technology has demonstrated its effectiveness in improving the quality of life for heart failure patients.
Simos Kedikoglou, C.E.O. at Impulse Dynamics, shared, “We are helping people through a completely different way. Obviously, everybody will exhaust pharmaceutical treatment before they consider any device. But instead of moving to the very invasive heart transplant that costs hundreds of thousands of dollars and it’s extremely invasive for the patient, we have a stimulator.”
The CCM® therapy device took more than 20 years of research. In 2015, it was approved by the Food and Drug Administration and given a breakthrough-device designation. It is the first and only cardiac contractility modulation device approved by the F.D.A. Earlier versions have been implanted in more than 5,000 patients worldwide. The Optimizer® device is now in its fifth generation.
The device is implanted inside the skin of the upper chest, and two commercially available pacemaker leads are attached to the heart’s right ventricle. During the implantation, the device is activated to deliver CCM® therapy to the heart muscle. The implantation process is simple, and patients can usually return home the same day.
The device works in a basic manner. CCM® is delivered in five one-hour increments spread evenly throughout the day. Over time, its effect on the heart is similar to exercising for more than three months. The patients begin feeling better, and many reported having a better outlook on life.
According to Mr. Kedikoglou, “We’re not replacing the pump. We’re just training the pump. We’re supporting the pump and giving it the ability to deliver the blood that the body needs.”
CCM® therapy trains the pump to deliver oxygen-rich blood more efficiently to the other body parts, subsequently improving the heart’s function.
To sustain efficacy, the Optimizer® is charged once per week for 45 minutes to one hour. An external charger placed over the internal device ensures the best use of the Optimizer® for the following week.
The Optimizer® device is groundbreaking, efficient, and can improve patients’ lives without invasive surgery.
Heart failure patients with CCM® therapy devices have shown tremendous improvements beyond what they can get from medications. Impulse Dynamics has conducted numerous studies on the effectiveness of the CCM® therapy as delivered by the Optimizer® devices.
In 2019, a study was conducted to assess the long-term impact of CCM® on patients with NYHA class III or IV symptoms and left ventricular ejection fraction. One hundred forty patients participated in this study and were tracked through three years with multiple KPIs in consideration. Results showed that CCM® therapy decreased hospitalizations by 75%.
For more information on this and other clinical studies conducted, visit https://impulse-dynamics.com/providers/clinical-trials/.
Simos explained that patients get back hope through CCM® therapy. They show 20 to 50% improvement in their ability to do things, like walking and exercising. “Our patients, typically, when they start, can walk only around 1,000 feet. They see an improvement that we’ve illustrated in studies conducted over six and 12 months. These findings show that life continues for longer than three to four years. They can devote time to activities in their daily life — do a lot more — and therefore, they report much higher satisfaction,” Simos added. “We have patients that have been able to resume all manner of activities. Others have been able to return with confidence back to their professional lives. Some have been seen dedicating a lot of time doing what they want to do in retirement, such as fishing or even mountain climbing that was completely off-limits before. And that’s the biggest sign of encouragement — witnessing patients discovering how much better they feel and demonstrating it through being active again.”
The Impulse Dynamics website offers a wide array of patient testimonials on how CCM® therapy has impacted their lives.
In healthcare, cost matters.
Cardiovascular surgery for transplant or LVAD is enormously costly and can be too much for patients with inadequate insurance coverage. With the Optimizer® device, patients, especially those who are not yet qualified for a heart pump replacement, can hope for more effective treatment outcomes without paying the substantial price involved in the more complicated surgery. Fortunately, for those insured or who are on Medicare, their insurance typically covers the device. Moreover, it is rechargeable, sparing the patient of surgery for a few more years.
For the provider side, think of how much savings the Optimizer® device can bring. It reduces hospitalizations and readmissions, which means less cost to the hospital.
Impulse Dynamics’ Optimizer® device is a huge success. Mr. Kedikoglou revealed that they are signing up more and more providers, and nearly every state in the U.S. has providers that offer the device. The Optimizer® is also available in Europe, China, Brazil, India, and 40 other countries globally.
This year, the company announced that it had raised $60 million in funding that will be used to commercialize the Optimizer® device, ensuring that the CCM® therapy will reach more patients and impact more people’s lives.
For my entire conversation with Simos Kedikoglou, please visit: https://outcomesrocket.health/impulse-dynamics/2021/03/
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Siemens Healthineers North America