Impulse Dynamics – the company for which I am CTO and Executive VP – announced today that it received European approval for labeling the OPTIMIZER Smart IPG as MR-Compliant for full-body MRI scans utilizing 1.5 Tesla scanners:
Impulse Dynamics, Inc., a company dedicated to improving the lives of people with heart failure, today announced its innovative CCM® therapy delivered by the Optimizer® system received an award from the R&D 100 Awards, a prestigious program honoring research and development pioneers and their revolutionary ideas in science and technology.
“Winning this award is a tremendous accomplishment for our company as it represents the recognition by fellow scientists and engineers for the enormous effort that has gone into developing this breakthrough technology. The therapy serves a huge unmet need for a very large group of heart failure patients who suffer every day with their symptoms, so it’s great for the technology to receive recognition at this level,” said David Prutchi, Ph.D., Chief Technology Officer and Executive Vice President at Impulse Dynamics. “I am pleased to congratulate all my colleagues that helped evolve what was initially an intriguing electrophysiological discovery into the transformational therapy that it is today.”
Impulse Dynamics’ website: www.impulse-dynamics.com
Impulse Dynamics (where I’m Executive VP of Product Development) announced today the completion of an $80.25 Million Series D financing round with major new investors, including strategics. According to the press release:
“Impulse Dynamics, developer of Optimizer® Smart System for delivering CCM™ therapy, announced the completion of an $80.25 million Series D financing with new investors. The proceeds will be used primarily to facilitate U.S. commercialization of the Optimizer Smart, an FDA-approved implantable device for treating chronic heart failure that has been proven to strengthen the heart and help it beat more forcibly. Led by well-respected medical technology investor Amzak Health Investors, the round also included Wellington Management, Kennedy Lewis Investment Management, Acorn Biosciences and Minth Holdings Limited; strategic investors Zoll Medical Corporation, Abiomed and one additional corporate investor; and the company’s chief executive and chief financial officers.”
Impulse Dynamics – the company for which I work – announced during HRS that a first patient received the Optimizer® Smart System for delivering CCM™ therapy since the device was approved by the U.S. Food and Drug Administration. The implant was performed on May 6, 2019 at The Ohio State University Wexner Medical Center.
The start of commercial implants in the U.S. is a major milestone for the Company. It makes me very proud that the technology on which I have worked for over 21 years is now available to make a dramatic change to the lives of heart failure patients across the U.S.
I have led the development of devices to deliver CCM™ therapy from the very beginning, so it is with great pleasure and pride that I share with you the exciting news that Impulse Dynamics just received approval from the United States Food and Drug Administration (FDA) for our Optimizer® Smart System for heart failure patients! An official FDA announcement was made through the publication of a press release that you can find here: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm634103.htm.
Impulse Dynamics’ press release is as follows:
Impulse Dynamics receives FDA approval for breakthrough Optimizer® Smart System delivering CCM™ therapy for treatment of heart failure
Orangeburg, New York, March 21, 2019 – Impulse Dynamics, developer of the implantable Optimizer® Smart System for delivering CCM™ therapy, announced today that it has received approval from the United States Food and Drug Administration for its first-in-class Optimizer Smart System.
Designed to address a significant unmet medical need in heart failure, the Optimizer Smart System received Breakthrough Device designation from the FDA in 2015. It was the first breakthrough device to go before the Circulatory System Devices Panel of the FDA’s Medical Devices Advisory Committee, on Dec. 4, 2018, receiving a 12-0 vote on the benefit-to-risk ratio of the device.
“With the FDA’s approval of the Optimizer System for the delivery of CCM, we finally have available in the US an effective device-based therapy for advanced heart failure patients with mildly to moderately reduced left ventricular ejection fractions who are not eligible for CRT,” said Professor William T. Abraham, MD, Professor of Medicine, Physiology, and Cell Biology, and College of Medicine Distinguished Professor at the Ohio State University Wexner Medical Center. “The Optimizer System, along with guideline-directed medical therapies, can improve the lives of many heart failure patients in the US who previously did not have access to this therapy. As such, it represents a real game-changer for these patients.”
The Optimizer Smart System is the first and only CCM device approved by the FDA to improve 6-minute hall walk distance, quality of life and functional status of NYHA Class III heart failure patients who remain symptomatic despite guideline directed medical therapy, who are in normal sinus rhythm, are not indicated for CRT, and have an LVEF ranging from 25% to 45%. Only 30 percent of moderate to severe chronic heart failure patients are candidates for CRT, which historically has left 70 percent of patients with few options to help them manage their disease.
“FDA approval is the culmination of many years of clinical development for this disruptive technology, addressing a significant unmet need in today’s heart failure treatment paradigm,” commented Dr. Daniel Burkhoff, Impulse Dynamics’ Medical Advisor. “We continue to develop the technology with ongoing clinical trials designed to evaluate CCM therapy in additional heart failure populations.”
CCM is a unique electrical pulse delivered during the absolute refractory period, which is just after the heart contracts. In contrast to a pacemaker or defibrillator, CCM works by modulating the strength of the heart muscle contraction rather than the rhythm.
Dr. Simos Kedikoglou, Impulse Dynamics’ CEO, announced that the Company will launch the device in the US later this year. “We are extremely excited that the Optimizer Smart System with CCM therapy is now available in the United States,” he said. “We look forward to growing our commercial presence in the US and globally.”
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 during the absolute refractory period of the heart cycle to improve systolic contraction of the heart. The Optimizer System has been implanted in over 3,500 patients and is currently available in Europe, China, Brazil, India, and more than 40 other countries around the world. Impulse Dynamics has completed numerous clinical studies, including several randomized controlled trials. The results have been published in over 80 papers in leading medical journals.
About Impulse Dynamics
Impulse Dynamics is focused on the development of electrical therapies for the treatment of chronic heart failure. As a global leader in cardiac medical innovation, Impulse Dynamics has operations in the United States, Europe, and Asia. For more information please visit www.impulse-dynamics.com.
Impulse Dynamics (USA), Inc.
30 Ramland Road South, Suite 204
Orangeburg, NY 10962
Welcome to implantable-device.com, a blog dedicated to professionals interested in the fascinating world of active implantable medical devices!
Let me tell you a bit about myself: I have over twenty-five years of experience in the design of Medical Electronic Instrumentation, most of it developing active implantable medical devices. In addition to over 40 papers and 80 patents on implantable medical devices, I am the lead author of the books “Design and Development of Medical Electronic Instrumentation”, “Exploring Quantum Physics Through Hands-On Projects,” and “Exploring Ultraviolet Photography – Bee Vision, Forensic Imaging, and Other Adventures in Ultraviolet Photography.”
Please contact me if you would like to contribute to the blog, correct information that you find in these pages, make a news release, or if you have a picture of an implantable device that you would like to share with everyone else.
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David Prutchi, Ph.D.