{"id":241197,"date":"2022-04-29T08:00:56","date_gmt":"2022-04-29T12:00:56","guid":{"rendered":"https:\/\/impulse-dynamics.com\/?p=241197"},"modified":"2024-01-17T04:28:23","modified_gmt":"2024-01-17T09:28:23","slug":"impulse-dynamics-launches-optimizer-smart-mini","status":"publish","type":"post","link":"https:\/\/impulse-dynamics.com\/global\/impulse-dynamics-launches-optimizer-smart-mini\/","title":{"rendered":"Impulse Dynamics Launches Optimizer Smart Mini"},"content":{"rendered":"

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PRESS\u00a0
RELEASE<\/h2>\n

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Smaller, Smarter, Long-lasting Device Gives Patients a Reason To Believe There Is a Tomorrow<\/em><\/strong><\/h2>\n

MARLTON, N.J., April 29, 2022 <\/strong>(GLOBE NEWSWIRE) \u2014 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\u00ae 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.<\/p>\n

\u201cI\u2019m excited about the potential of this device to improve quality of life in patients already on optimal medical therapy,\u201d 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. \u201cWe\u2019ve 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.\u201d<\/p>\n

\u201cThe 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,\u201d said Dr. Hirak Shah, a heart failure cardiologist at KUMC, and the physician who referred this patient for CCM therapy. \u201cThis type of innovation makes me very excited and optimistic about the future of device-based therapies in the field of heart failure.\u201d<\/p>\n

\u201cReducing the size of the device and extending its feature set while simultaneously extending its longevity took a great deal of ingenuity and cooperation,\u201d said David Prutchi, Ph.D., Impulse Dynamics\u2019 Chief Technology Officer and architect of the Optimizer Smart Mini platform. \u201cThis 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.\u201d<\/p>\n

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.<\/p>\n

\u201cThe launch of the new platform is another sign of our commitment to helping HF patients live a better life,\u201d said Jason Spees, Impulse Dynamics\u2019 President and Chief Commercial Officer. \u201cEarlier 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.\u201d<\/p>\n

The Optimizer Smart Mini delivers CCM therapy \u2014 the company\u2019s proprietary technology \u2014 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.<\/p>\n

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About the Optimizer and CCM\u00ae<\/sup><\/span><\/em><\/strong> Therapy<\/strong>
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 \u201cBreakthrough Device\u201d 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.<\/p>\n

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About Impulse Dynamics<\/strong>
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<\/em><\/strong>\u00ae<\/sup><\/span> therapy, which is delivered by the company\u2019s Optimizer system, a breakthrough, FDA-approved treatment verified to improve the quality of life for heart failure patients.[1]<\/a> 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<\/sup> \u00a0To learn more, visit www.ImpulseDynamics.com<\/a>, or follow the company on social media at LinkedIn<\/a>, Twitter<\/a>, and Facebook<\/a>. [1]<\/a> https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC5494150\/<\/a><\/p>\n

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\nImpulse Dynamics (USA), Inc.<\/strong>
50 Lake Center Executive Park, 401 Route 73 N, \u2010 Building 50 Suite 100
Marlton, NJ 08053
Phone: (856) 642\u20109933
www.impulse\u2010dynamics.com<\/p>\n

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INVESTOR<\/strong> CONTACT<\/strong>:<\/p>\n

Harriss Currie
CFO
Impulse Dynamics
hcurrie@impulsedynamics.com<\/a>
856-642-9933<\/p>\n

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MEDIA CONTACT: <\/strong>\u00a0<\/strong><\/p>\n

Rex Richmond
Director of Media Relations
Impulse Dynamics
rrichmond@impulsedynamics.com<\/a>
856-642-9933<\/p>\n

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PUBLIC RELATIONS: <\/strong>\u00a0<\/strong><\/p>\n

Ian Segal
Manager, Public Relations
Impulse Dynamics
isegal@impulsedynamics.com<\/a>
856-642-9933<\/p>\n

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