The First Workshop on Active Implantable Medical Devices took place at in Punta del Este, Uruguay last Friday (March 1st 2024) as part of the LASCAS 2024 meeting.
Category Archives: Impulse Dynamics
Implantable devices and systems by Impulse Dynamics
Impulse Dynamics Completes $136M Financing Round
Impulse Dynamics, the company where I’m CTO and Executive VP, announced yesterday that it completed a $136M financing round to accelerate its commercial growth and advancing the development of pipeline products.
From the announcement:
“Marlton, NJ, Feb. 14, 2024 (GLOBE NEWSWIRE) — Impulse Dynamics plc, a global medical device company dedicated to improving the lives of people with heart failure (HF), is proud to announce that it raised $136 million in financing to accelerate investment in global commercialization, technology, product innovation, and further development of clinical evidence. The financing was led by Perceptive Advisors, Redmile Group, Alger, and Hobart Healthcare. This substantial investment reflects investor confidence in, and commitment to, the company’s vision and expansion.
…
The funding will fuel commercialization efforts, develop future product pipelines, and support groundbreaking clinical trials such as the INTEGRA-D and AIM HIGHer clinical trials. The INTEGRA-D trial is a multicenter study evaluating the combination of CCM and ICD therapy in a single device – the Optimizer Integra CCM-D System. The AIM HIGHer clinical trial is a multicenter study with the objective to evaluate the safety and efficacy of CCM therapy in patients with symptomatic HF with an ejection fraction (EF) of 40 to 60 percent (inclusive). The trial is currently in its initial enrollment phase and has generated significant attention, feedback, and excitement among experts in HF.”
Lepu Medical Granted Chinese “Green Channel” for Implantable Cardiac Contractility Modulator (ICCM)
Image Credit: Lepu Medical Technology (Beijing) Co., Ltd.
Chinese Lepu Medical Technology (Beijing) Co., Ltd. announced on LinkedIn on January 5, 2024 that it had been granted “Green Channel” review status by the NMPA for its Implantable Cardiac Contractility Modulator (ICCM).
According to the LinkedIn post, the device to be reviewed by the Chinese NMPA is “an implantable pulse generator that utilizes cardiac contractility modulation therapy to treat symptoms in patients with heart failure. This product is suitable for adult patients with New York Heart Association (NYHA) functional class III or IV heart failure, aiming to improve the patients’ 6-minute walking distance, quality of life, and cardiac functional status.”
Despite Lepu’s claim in the post that “the adoption of cardiac contractility modulation therapy is the first of its kind in China,” in fact, Cardiac Contractility Modulation was pioneered by Impulse Dynamics which has had commercial approval in China for its OPTIMIZER CCM™ devices since 2017.
Impulse Dynamics receives full-body MRI-conditional approval for OPTIMIZER Smart Mini System
Impulse Dynamics, the company for which I am the CTO, announced that FDA has approved full-body MRI-conditional labeling for the OPTIMIZER Smart Mini IPG. According to the announcement:
“The Optimizer Smart Mini system delivers the company’s proprietary CCM® therapy. This conditional approval expands the product labeling to allow for full-body magnetic resonance (MRI) diagnostic imaging with 1.5 and 3.0 Tesla (T) scanners. The approval for use with full-body MRI covers new patients adopting CCM therapy as well as existing Optimizer Smart Mini users.”
Impulse Dynamics Announced First Implant for Integra CCM-D™ Clinical Trial in May 2023
Image credit: Impulse Dynamics
Impulse Dynamics, the company where I am the CTO and Executive VP of Product Development, announced on May 18, 2023 the completion of the first implantation for the INTEGRA-D clinical trial, designed to evaluate the safety and efficacy of two proven cardiac therapies combined — CCM® and an implantable cardioverter defibrillator (ICD) — in a single device (CCM-D). The Optimizer® IntegraTM CCM-D System delivers CCM therapy to improve quality of life and reduce heart failure symptoms, and ICD therapy to treat life-threatening arrhythmias that may cause sudden cardiac death. The investigational technology is rechargeable with long battery life, potentially reducing the need for replacement procedures.
Impulse Dynamics Launched Optimizer Smart Mini in April 2022
Image Credit: Impulse Dynamics
Back on April 29, 2022, Impulse Dynamics, the company where I am the CTO and Executive VP of Product Development, announced both FDA and CE Mark approval and the official commercial launch of the Optimizer® Smart Mini System.
According to the press release:
The Optimizer Smart Mini delivers CCM therapy — Impulse Dynamics’ 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.
The OPTIMIZER Smart Mini 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.
Impulse Dynamics Implants First Patient in AIM HIGHer Trial to Treat HF with High EF
On March 14, 2022, Impulse Dynamics (of which I am the CTO and Executive VP) conducted the first implant of a patient in its AIM HIGHer trial. The goal of the blinded study is to evaluate the performance of CCM Therapy to treat heart failure in a population with high ejection fraction (LVEF between 40% and 60%, inclusive).
According to the press release:
“Patients can have HF with severely reduced, moderately reduced, or even preserved ejection fraction (e.g., EF close to the normal range of 60% or above.) Those patients with severely reduced or moderately reduced EF have therapeutic options, including many classes of pharmaceuticals and device therapies such as CCM. However, HF patients with higher EF (e.g., above 40%) have had few therapeutic options thus far to alleviate their symptoms and treat their disease. The purpose of AIM HIGHer is to assess the potential of CCM to improve performance and reduce cardiovascular morbidity and mortality for these patients.
…
The Optimizer delivers cardiac contractility modulation therapy — a proprietary technology of Impulse Dynamics — to the heart. Impulse Dynamics has designed CCM therapy to significantly improve heart contraction, allowing more oxygen-rich blood to be pushed out through the body. This breakthrough device has demonstrated its capability of enhancing the quality of life for HF patients no longer responding adequately to medication meant to manage their symptoms.”
AIM HIGHer is the largest randomized sham-controlled therapeutic cardiac device trial to ever be conducted.
Papers Supporting MR-Conditional IPG/Lead Mix-and-Match Presented at ISMRM 2021
My colleagues and I presented yesterday two posters at the meeting of the International Society for Magnetic Resonance in Medicine (ISMRM). In these papers we provide support for the idea that MR-conditional leads from one system can be matched with MR-conditional IPGs from a different system without compromising safety related to RF-induced heating .
D. Prutchi, J. Meyers, R. Shehada, RF Impedance of MR-Conditional Pacemaker Leads when Connected to Implantable Pulse Generators from Different MR-Conditional Systems, ISMRM 2021, Poster 1701_2281, Paper
In this paper,we demonstrate that at 63.87 MHz the RF impedance of IPGs is minimal relative to that of the leads, which dominates the overall impedance of the implantable system. Accordingly, mixed hybrid systems composed of MR-Conditional leads and any MR-Conditional IPG are expected to have a comparable overall impedance and consequently produce the same RF-induced heating as their corresponding original systems specified by the manufacturers.
J. Meyers, D. Prutchi, R. Shehada, Input Impedance Comparison of MR-Conditional Cardiac Implantable Pulse Generators at the 1.5T MR Frequency of 63.87 MHz, ISMRM 2021, Poster 2311, Paper
In this study, we measured the impedance at 63.87 MHz of several MR-conditional IPGs from different manufacturers to assess the role of the IPG in determining the RF-induced heating at the lead electrodes. From the narrow impedance range measured, we suggest that the IPG component of an MR-Conditional system could be interchanged without compromising safety.
We also presented the following poster:
D. Prutchi, J. Meyers, R. Shehada, Importance of Pacemaker Lead Preconditioning for MR Safety In-Vitro Studies, ISMRM 2021, Poster 2282, Paper
In this study we investigated the change in the RF filtering characteristics of the leads of active implantable medical devices (AIMDs) as body fluids seep into the leads during the initial post implant period. Our findings indicate that the RF characteristics change dramatically with fluid absorption, making it necessary to precondition the leads by soaking in isotonic saline solution to simulate the in-vivo scenario when conducting in-vitro MR safety testing. Furthermore, leads designed with RF-attenuating lumped inductances must consider the effect of fluid absorption on changing the peak RF attenuation frequency.
Impulse Dynamics’ OPTIMIZER Smart Approved for Whole-Body MRI in Europe
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:
FDA/CE MR-Conditional Approvals for Impulse Dynamics’ OPTIMIZER Smart IPG
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.
CCM Therapy Delivered by the Optimizer System Wins R&D 100 Award
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’ Medical Director Interviewed by Medgadget
Dr. Ishu Rao is the Medical Director for Impulse Dynamics – the company where I am Executive VP of Product Development. Medgadget featured a very interesting interview with Dr. Rao where he described the use of CCM™ therapy for the treatment of Heart Failure.
Impulse Dynamics Secures Transitional Pass-Through for OPTIMIZER Smart
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.
FDA Approves Impulse Dynamics’ Next-Generation 2-Lead OPTIMIZER Smart
Impulse Dynamics – the company where I am Executive VP of Product Development – announced the FDA approval of a PMA supplement for the next-generation, two-lead Optimizer Smart System for treating heart failure.
First U.S. Commercial Implant of Impulse Dynamics’ OPTIMIZER Smart System
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.