Over 64 Million Adults Worldwide Have Heart Failure
We’re determined to do something about it!
Impulse Dynamics is a fast-growing medical device company that has pioneered a new form of therapy for heart failure called cardiac contractility modulation. This treatment, which is provided by the company’s Optimizer® Smart System, which delivers CCM therapy, is FDA-approved and designated as a breakthrough device. CCM is a ﬁrst-of-a-kind, proprietary, life-changing treatment alternative for a vast population of heart failure patients worldwide.
We are driven with an unwavering commitment to signiﬁcantly improve the lives of heart failure patients using cardiac contractility modulation.
Driven to bring hope and a new path of help for heart failure patients across the globe, we designed a framework of achieving goals by:
- Striving for excellence in all daily work.
- Abiding by all regulatory requirements.
- Facilitating global access to our therapy.
- Exceed expectations of patients and caregivers.
- Foster innovation, honesty, and accountability.
- Cultivate an environment attracting outstanding talent.
- Build signiﬁcant value for our shareholders.
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50 Lake Center Executive Park
401 Route 73 N, Building 50, Suite 100
Marlton, NJ 08053-3449
Phone: +1(856) 642-9933
Fax: (856) 642-0801
Worldwide Clinical and Regulatory Affairs Offices
One Blue Hill Plaza
PO Box 1582, Floor 16
Pearl River, New York 10965
Phone: +1(845) 359-2389
Impulse Dynamics Germany GmbH
International Commercial Operations
Main Airport Center
60549 Frankfurt am Main
Phone: +49 (0)69 – 566 081 300
- The Unmet Need: Heart Failure
- CCM Therapy: A Breakthrough Approach
- CCM Therapy: A New and Eﬀective Option for Millions of Heart Failure Patients
- How it Works
- Is the Optimizer like a pacemaker or deﬁbrillator?
- Improving the Lives of Heart Failure Patients Through CCM Therapy
- Speak With Your Healthcare Provider
The Unmet Need: Heart Failure
- Heart failure aﬀects an estimated 6.5 million Americans and nearly over 64 million people worldwide.1
- By 2030, over 8 million people in the United States — one in every 33 — will have HF.2
- Heart failure is a condition in which the heart slowly weakens and cannot pump with force required to supply oxygen-rich blood to meet the body’s needs.
- Patients with heart failure experience debilitating symptoms, including breathlessness, fatigue, confusion, and swelling in the legs that make everyday activities challenging and signiﬁcantly diminish their quality of life.
- Traditional treatments for heart failure provide limited, or no, improvement to the heart’s pumping forcefulness, and nearly 50 percent of people with heart failure die within ﬁve years of being diagnosed.2
- Today, most heart failure patients are prescribed medications intended to slow the progression of the disease and manage their symptoms.
- As the condition progresses, these treatments lose their eﬀectiveness, and the quality of life for heart failure patients will continue to decline.
- The total annual cost for heart failure is projected to reach $70 billion by 2030.2
The Unmet Need: Heart Failure
- CCM therapy is delivered by the Optimizer, a minimally invasive, implantable device. The innovative treatment is the ﬁrst of its kind designed to improve contraction of the heart, allowing more oxygen-rich blood to reach the body.3
- Studies evaluating the FDA-approved therapy have demonstrated the device is safe and is proven to improve quality of life for suitable patients.3
- The Optimizer delivers cardiac contractility modulation, the company’s proprietary technology, to the heart.3
- CCM therapy provides 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 safe and eﬀective in numerous clinical studies, including several randomized controlled trials. The results have been published in over 80 articles appearing in leading medical journals.4
- The Optimizer Smart system was granted “Breakthrough Device” designation by the FDA and is the ﬁrst and only FDA-approved (as of March
2019) device in the United States or elsewhere to oﬀer CCM therapy.
- The Optimizer has been used to treat over 5,500 patients. It is currently available in the United States, Europe (obtained CE Mark in October 2016), China, Brazil, India, and more than 40 other countries worldwide.
CCM Therapy: A New and Eﬀective Option for Millions of Heart Failure Patients
- CCM therapy is an innovation that can improve the lives of many heart failure patients who continue to experience symptoms despite receiving medical therapy.3
- The therapy is a new option that improves the quality of life for patients who are no longer adequately responding to medications to manage symptoms or slow the progression of heart failure.3
- CCM therapy may be an appropriate treatment option for approximately 70 percent of NYHA Class III heart failure patients who remain symptomatic despite guideline-directed medical therapy.3
How it Works
- The Optimizer device is similar in size to a pacemaker and is implanted during a minimally invasive procedure while the patient is under light sedation.
- During the procedure, the device is implanted under the skin of the upper chest, along with electrical leads placed in the heart’s right ventricle through the veins (transcatheter).
- After the procedure, the physician programs the delivery of CCM therapy for each patient and activates the device.
- The implanted device then sends electrical pulses to the heart muscle for a total of ﬁve hours a day, in
one-hour treatments separated by regular intervals.
- From the comfort of their home, the patient charges the device each week for one hour using an external charger.
- The Optimizer has been rigorously tested, and it is expected to provide CCM therapy for up to 15 years before requiring replacement.
Is the Optimizer like a pacemaker or deﬁbrillator?
- In some ways, yes, for example, both are implanted under the skin of the upper chest, and they each use leads to deliver therapy to the heart muscle. But that’s where the similarities end.
- Unlike a pacemaker or deﬁbrillator, Optimizer devices deliver CCM therapy during the cardiac cycle’s
non-excitatory or absolute refractory period. Instead of causing a contraction, CCM therapy is designed to cause subsequent beats of the heart to be stronger or more forceful, resulting in more oxygen-rich blood to be delivered to the body with each beat.
- A pacemaker is used to treat slow heart rhythm disturbances, which are symptomatic. Deﬁbrillators can do that and can deliver lifesaving therapy if and when patients experience life- threatening electrical disturbances called arrhythmias. Cardiac contractility modulation is used to treat patients with heart failure to make their hearts beat stronger and make them feel better.
Improving the Lives of Heart Failure Patients Through CCM Therapy
- Impulse Dynamics is dedicated to improving people suﬀering heart failure by transforming how the condition is treated.
- CCM therapy, which is delivered by the company’s Optimizer system, is a breakthrough, FDA-approved treatment that is proven to improve the quality of life for heart failure patients.3
- CCM therapy is a safe and eﬀective minimally invasive treatment option for many heart failure patients who otherwise have few eﬀective options available to them.3
- The company is headquartered in Marlton, New Jersey, and has oﬃces in Pearl River, New York, and Frankfurt am Main, Germany.
- Visit ImpulseDynamics.com or follow the company on LinkedIn, Facebook, Twitter, and Instagram to learn more.
- As of the date of this publication, the company has several hundred employees and is aggressively hiring talent weekly to ﬁll critical roles in the organization.
Speak With Your Healthcare Provider
CCM® therapy is an FDA-approved and designated “Breakthrough” heart failure treatment.
- Can improve quality of life5
- Can improve functional status5
- Works diﬀerently than medications
- FDA-approved minimally invasive procedure
As with any medical procedure, individual results may vary. Speak with your cardiologist about the beneﬁts and risks before moving forward with any treatment. While rare, adverse events can include infection, bleeding, chest pain, arrhythmias, tissue damage, worsening heart failure, stroke, and death.
1 Groenewegen A, Rutten FH, Mosterd A, Hoes AW. Epidemiology of Heart Failure. European Journal of Heart Failure. 2020;22(8):1342-1356. doi:10.1002/ejhf.1858
2 Benjamin EJ, Blaha MJ, Chiuve SE, et al. Heart disease and stroke statistics—2017 update: A report from the American Heart Association. Circulation. 2017;135(10). doi:10.1161/cir.0000000000000485
3 Abraham WT, Lindenfeld JA, Reddy VY, et al. A randomized controlled trial to evaluate the safety and eﬃcacy of cardiac contractility modulation in patients with moderately reduced left ventricular ejection fraction and a narrow QRS duration: Study rationale and design. Journal of Cardiac Failure. 2015;21(1):16-23. doi:10.1016/j.cardfail.2014.09.011
4 Kuschyk J, Falk P, Demming T, et al. Long‐-term clinical experience with cardiac contractility modulation therapy delivered by the optimizer smart system. European Journal of Heart Failure. 2021.doi:10.1002/ejhf.2202
5 Abraham WT, Burkhoﬀ D, Nademanee K, et al. A randomized controlled trial to evaluate the safety and eﬃcacy of cardiac contractility modulation in patients with systolic heart failure: Rationale, design, and Baseline Patient Characteristics. American Heart Journal. 2008;156(4). doi:10.1016/j.ahj.2008.05.019