PRESS
RELEASE
Smaller, Smarter, Long-lasting Device Gives Patients a Reason To Believe There Is a Tomorrow
MARLTON, N.J., April 29, 2022 (GLOBE NEWSWIRE) — Impulse Dynamics, a global medical device company dedicated to improving the lives of people with heart failure (HF), is proud to announce today both FDA and CE Mark approval and the official commercial launch of the Optimizer® Smart Mini. This device, which will soon be available in both the United States and Europe, is 25 percent smaller and 33 percent lighter than the currently marketed Optimizer Smart.
“I’m excited about the potential of this device to improve quality of life in patients already on optimal medical therapy,” said Dr. Rhea Pimentel, Director of the Electrophysiology Lab at the University of Kansas Medical Center, who has already implanted the new CCM therapy device in a pre-market evaluation. “We’ve had a lot of experience with CCM using the Optimizer Smart device, but the next generation Optimizer Smart Mini CCM is simpler to implant and more comfortable for patients.”
“The Optimizer Smart Mini is a major advance for CCM therapy. The combination of a twenty-year battery life and heart failure diagnostic monitoring makes this an incredibly appealing option for patients with heart failure,” said Dr. Hirak Shah, a heart failure cardiologist at KUMC, and the physician who referred this patient for CCM therapy. “This type of innovation makes me very excited and optimistic about the future of device-based therapies in the field of heart failure.”
“Reducing the size of the device and extending its feature set while simultaneously extending its longevity took a great deal of ingenuity and cooperation,” said David Prutchi, Ph.D., Impulse Dynamics’ Chief Technology Officer and architect of the Optimizer Smart Mini platform. “This device utilizes an entirely new electronic chipset packaged into a compact, physiologically shaped implantable enclosure. The platform also includes a new, feature-rich programmer and charger designed to dramatically simplify the programming and use of the device.”
The new technology offers increased battery longevity of 20 years (compared to 15 years in the previous generation), advanced HF diagnostic monitoring capabilities (e.g., heart rate, heart rate variability, patient posture and position), and remote patient monitoring features that will be activated in the near future.
“The launch of the new platform is another sign of our commitment to helping HF patients live a better life,” said Jason Spees, Impulse Dynamics’ President and Chief Commercial Officer. “Earlier this week, we announced a very significant milestone, bringing hope to the 7,000th CCM patient worldwide. The commercial release of the Optimizer Smart Mini platform offers innovation that makes this therapy easier to use and helps us offer hope to many thousands more HF patients. This is one of many launches to come based on our commitment to a rapid cadence of product innovation to serve a patient population estimated to be at least twice the size of the patient population indicated for cardiac resynchronization therapy.”
The Optimizer Smart Mini delivers CCM therapy — the company’s proprietary technology — to the heart. CCM therapy has been designed by Impulse Dynamics to significantly improve heart contraction, allowing more oxygen-rich blood to be pushed out through the body. CCM therapy is indicated to improve 6-minute hall walk, quality of life, and functional status of NYHA Class III heart failure patients who remain symptomatic despite guideline-directed medical therapy, are not indicated for CRT, and have a left ventricular ejection fraction ranging from 25 to 45 percent.
About the Optimizer and CCM® Therapy
CCM is the brand name for Cardiac Contractility Modulation, the non-excitatory electrical pulses delivered by the implantable Optimizer device to improve systolic contraction of the heart. The Optimizer Smart System was granted “Breakthrough Device” designation by the U.S. Food and Drug Administration, and it is the first and only CCM device approved in the U.S. CCM therapy sends unique electrical pulses to the heart cells during the absolute refractory period, which occurs just after the heart initiates contractions. In doing so, it strengthens and helps the heart contract more forcibly. Impulse Dynamics has completed numerous clinical studies, including several randomized controlled trials, the results of which have been published in over 80 articles appearing in leading medical journals. Studies have shown CCM therapy to sustainably improve 6-minute hall walk distance, quality of life, and functional status among patients who are candidates for the device. The Optimizer Smart has been implanted in over 4,000 patients and is currently available in the U.S., Europe, China, Brazil, India, and more than 40 other countries around the world.
About Impulse Dynamics
Impulse Dynamics, based in Marlton, N.J., is dedicated to helping healthcare providers enhance the lives of people with heart failure by transforming how the condition is treated. The company has pioneered CCM® therapy, which is delivered by the company’s Optimizer system, a breakthrough, FDA-approved treatment verified to improve the quality of life for heart failure patients.[1] CCM therapy is a safe and effective minimally invasive treatment option for many heart failure patients who otherwise have few alternatives available to them.1 To learn more, visit www.ImpulseDynamics.com, or follow the company on social media at LinkedIn, Twitter, and Facebook. [1] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5494150/
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Phone: (856) 642‐9933
www.impulse‐dynamics.com
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