A blog about what is new (and old) in the world of active implantable medical devices

Category Archives: Cardiac Contractility Modulation

Impulse Dynamics Announced First Implant for Integra CCM-D™ Clinical Trial in May 2023

Posted on by Posted in Cardiac Contractility Modulation, Cardiac Pacing, Cardiac Stimulation (other), Cardioversion/Defibrillation, David Prutchi's Portfolio, Heart Failure (CHF), Impulse Dynamics, My Portfolio, Tachycardia
Impulse Dynamics OPTIMIZER Integra CCM-D IPG

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.

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Impulse Dynamics Launched Optimizer Smart Mini in April 2022

Posted on by Posted in Cardiac Contractility Modulation, Cardiac Stimulation (other), David Prutchi's Portfolio, Heart Failure (CHF), Impulse Dynamics, My Portfolio
Impulse Dynamics OPTIMIZER Smart Mini IPG by Impulse Dynamics

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

Posted on by Posted in Cardiac Contractility Modulation, Heart Failure (CHF), Impulse Dynamics, My Portfolio

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.

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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.

Impulse Dynamics Secures $80.25M Funding from Major Investors Including Amzac, Wellington, and Zoll

Posted on by Posted in Abiomed, AIMD Business, Cardiac Contractility Modulation, David Prutchi's Portfolio, Edwards, Heart Failure (CHF), My Portfolio, Zoll

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.”

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Impulse Dynamics Secures Transitional Pass-Through for OPTIMIZER Smart

Posted on by Posted in Cardiac Contractility Modulation, Heart Failure (CHF), Impulse Dynamics, My Portfolio

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.

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First U.S. Commercial Implant of Impulse Dynamics’ OPTIMIZER Smart System

Posted on by Posted in Cardiac Contractility Modulation, David Prutchi's Portfolio, Dr. Shlomo Ben-Haim (Medinvest), Heart Failure (CHF), Impulse Dynamics, My Portfolio

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.

 

FDA Approves breakthrough Optimizer® Smart System Delivering CCM™ Therapy for Treatment of Heart Failure

Posted on by Posted in Cardiac Contractility Modulation, Cardiac Stimulation (other), David Prutchi's Portfolio, Dr. Shlomo Ben-Haim (Medinvest), Heart Failure (CHF), Impulse Dynamics

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