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 – the company for which I am CTO and Executive VP – received MR-conditional approval (1.5 T head/limbs with peripheral coils) from both FDA and the European Union.
From the press release:
IMPULSE DYNAMICS ANNOUNCES FDA APPROVAL FOR MAGNETIC RESONANCE IMAGING FDA
Clears Potential Hurdle for Many Heart Failure Patients
MARLTON, N.J.–(BUSINESS WIRE)–Impulse Dynamics, a company dedicated to improving the lives of people with heart failure (HF), today announced the U.S. Food and Drug Administration (FDA) has approved the conditional use of Magnetic Resonance Imaging (MRI) for Optimizer® CCM® delivery systems. This approval represents a significant advance because the population that benefits most from cardiac contractility modulation therapy (patients with moderate to severe HF) often requires advanced diagnostic imaging procedures.
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 – the company for which I’m Executive VP of Product Development – announced that it has secured transitional pass-through (TPT) payment for the OPTIMIZER Smart System for the treatment of heart failure.
CMS has affirmed the substantial clinical improvement that Cardiac Contractility Modulation (CCM™ therapy) offers to patients with heart failure and adjusted the payment offered for the technology accordingly to facilitate access. The new payment, issued on Friday, Nov. 1, 2019 in CMS’s calendar year 2020 Outpatient Prospective Payment System (OPPS) final rule, eases access to CCM therapy in the hospital outpatient setting, with improved reimbursement taking effect on Jan. 1, 2020.
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
From Impulse Dynamics today:
FIX-HF-5C Late-Breaking Clinical Trial Data Presented at HRS 2018 with Simultaneous Publication in the Journal of the American College of Cardiology: Heart Failure
Orangeburg, New York, May 10, 2018 – Impulse Dynamics (USA), Inc. announced results from its FIX-HF-5C randomized, Controlled Trial of Cardiac Contractility Modulation in Heart Failure. The study results were presented by Prof. William Abraham, MD, Professor of Internal Medicine and Director, Division of Cardiovascular Medicine, The Ohio State University Wexner Medical Center, at the Heart Rhythm Society Late-Breaking Clinical Trials today in Boston, Massachusetts, with a simultaneous publication in the JACC: Heart Failure Journal.
CCM™ is a therapy unique to the Optimizer® family of devices that deliver electrical signals to the heart that are intended to reduce symptoms and improve exercise tolerance in patients with heart failure. The FIX-HF-5C study was designed to prospectively confirm a subgroup analysis of the prior FIX-HF-5 pivotal trial, showing that CCM™ significantly improved exercise tolerance and quality of life in patients with NYHA class III and IV heart failure symptoms, ejection fraction 25-45%, and a QRS <130ms. A Bayesian statistical analysis plan was developed to combine the data already available from the original FIX-HF-5 study with the FIX-HF-5C study data. The results presented today at HRS supplement and confirm the results from the prior study, meeting the safety and effectiveness objectives of the study.
Highlights of the results include:
- CCM™ is safe; the study met its primary and secondary safety endpoints.
- Patients receiving CCM™ showed significantly better exercise tolerance and quality of life compared to their control-group counterparts.
- The composite of cardiovascular deaths and heart failure hospitalizations was statistically significantly reduced in comparison to the control group.
- Clinical effectiveness was even greater in patients with EF >35%.
“The results of the FIX-HF-5C study exceeded my expectations by not only confirming the benefits of CCM™ on important patient-centered endpoints such as exercise capacity and quality of life, but also in demonstrating the potential for CCM™ to reduce heart failure morbidity and mortality” said Prof. Abraham. “These findings support the use of CCM™ as a breakthrough therapy for heart failure patients with moderately reduced left ventricular systolic function and narrow QRS durations, who currently have no other options for improvement.”
“I would like to thank the FIX-HF-5C Study Investigators and the Impulse Dynamics’ team for completing this important study with its very encouraging results.” said Dr. Simos Kedikoglou, Impulse Dynamics’ CEO.“We anticipate submission of the final PMA module to the U.S. FDA in June 2018.”
About the Optimizer® and CCM™ Therapy
CCM™ is the brand name for the nonexcitatory 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 several other countries around the world. Impulse Dynamics has completed numerous clinical studies, including several randomized controlled trials. The results have been published in over 70 publications in leading medical journals. The Optimizer® is limited to Investigational use only in the United States.
About Impulse Dynamics
Impulse Dynamics N.V. 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 http://www.impulse-dynamics.com
Impulse Dynamics (USA), Inc.
30 Ramland Road South, Suite 204
Orangeburg, NY 10962
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Mrs. Sharon Alon
Last week we performed the first human implant of the new OPTIMIZER Smart IPG intended for the treatment of Chronic Heart failure in patients that are symptomatic despite appropriate medical treatment.
The first implant of the Optimizer Smart was performed by Dr. Markus Reinartz (left in picture above) at the Herz-Jesu Hospital in Dernbach, Germany. The device’s new, two-lead configuration enables an easier and faster implantation procedure.
• The OPTIMIZER Smart System is not currently available in the US. The OPTIMIZER IVs System is currently an Investigational Device in the US.
• I am the Executive VP of Product Development at Impulse Dynamics. However, the statements and opinions expressed in this blog are my own and do not necessarily represent those of my employer.
• This blog post is not intended to act as an advertisement for Impulse Dynamics or its products.
A position paper was published yesterday by the European Heart Rhythm Association reporting on the performance of new devices for the treatment of heart failure (HF). The report has been endorsed by the Heart Failure Association.
The abstract for the paper titled “New devices in heart failure: an European Heart Rhythm Association report” reads:
Several new devices for the treatment of heart failure (HF) patients have been introduced and are increasingly used in clinical practice or are under clinical evaluation in either observational and/or randomized clinical trials. These devices include cardiac contractility modulation, spinal cord stimulation, carotid sinus nerve stimulation, cervical vagal stimulation, intracardiac atrioventricular nodal vagal stimulation, and implantable hemodynamic monitoring devices. This task force believes that an overview on these technologies is important. Special focus is given to patients with HF New York Heart Association Classes III and IV and narrow QRS complex, who represent the largest group in HF compared with patients with wide QRS complex. An overview on potential device options in addition to optimal medical therapy will be helpful for all physicians treating HF patients.
The report places special focus to patients with HF New York Heart Association (NYHA) Classes III and IV and narrow QRS complex, who represent the largest group in HF compared with patients with wide QRS complex (who are candidates for treatment with cardiac resynchronization therapy – CRT).
Active Implantable Medical Devices generate heat as a result of resistive losses in their circuitry, exothermic reaction in their batteries, eddy-current heating due to inductive recharge, friction between mechanical components, etc. The European Standard which regulates AIMDs limits the heating of the outer surface of an AIMD to 2ºC above normal body temperature. Despite the rapid growth in the use of AIMDs, the relationship between AIMD endogenous heat generation and tissue temperature has not been quantified. In the attached paper we aimed at determining the limit of endogenous heat that can be dissipated in-vivo by the surface area of an AIMD to remain compliant with the 2ºC temperature increase limit. In our study, four Sinclair mini-pigs underwent implantation of AIMD simulants instrumented to dissipate heat and measure temperature internally, as well as the device/tissue interface temperature.
We found that for a device with the surface area and geometry that we used, approximately 1W can be dissipated before reaching the 2ºC temperature increase limit.
Click here for a preprint of this paper
Impulse Dynamics (yes, the company for which I work) launched its new, CE-marked OPTIMIZER™ IVs implantable device for the treatment of heart failure at the 79th Annual Meeting of the German Cardiac Society (Mannheim, Germany, 3–6 April 2013).
The OPTIMIZER™ IVs Implantable Pulse Generator (IPG) is a programmable telemetric device intended to treat moderate to severe heart failure resulting from left ventricular dysfunction by monitoring intrinsic cardiac electrical activity and delivering Cardiac Contractility Modulation (CCM) signals during the ventricular absolute refractory period. These electrical signals are intended to influence myocardial properties in patients, thereby reducing their symptoms and improving quality of life and exercise tolerance.
The OPTIMIZER™ IVs IPG was designed to deliver CCM signals during the ventricular absolute refractory period in synchrony with locally-sensed electrical activity. The microprocessor controlled implantable device comprises intracardiac electrogram sensing circuits, control logic, communications circuitry, and circuitry to generate the CCM signals. Electrogram signals are detected from and CCM signals are delivered to the heart using standard chronically-implantable bipolar pacing leads. The implant procedure is similar to implantation procedures for other cardiac rhythm management devices.
Dr. Shlomo Ben-Haim has held faculty appointments as a Professor of Medicine, Physiology and Biophysics, at both Harvard University and the Technion – Israel Institute of Technology. His formal education is in the fields of nuclear physics, mathematics, biomedical engineering, philosophy, and medicine. Dr. Ben-Haim has published his research in over 100 scientific papers, in peer-reviewed journals. He holds over 180 patents and patent applications.
Currently, two companies led by Dr. Ben-Haim are focusing on active implantable medical devices:
Impulse Dynamics’ OPTIMIZER™ III Implantable Pulse Generator delivers Cardiac Contractility Modulation (CCM), non-excitatory electrical signals during the myocardial absolute refractory period in synchrony with locally sensed electrical activity. CCM signals are intended to treat patients with symptomatic heart failure despite appropriate medical treatment. Continue reading