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

Category Archives: Heart Failure (CHF)

Implantable devices for the treatment of Congestive Heart Failure (CHF)

Ceryx Medical developing Cysoni respiration-modulated pacemaker intended to treat Heart Failure

Posted on by Posted in Cardiac Pacing, Cyrix Medical, Heart Failure (CHF)
Ceryx Medical's Cysoni IPG

Image Credit: Ceryx Medical

Low Heart Rate Variability (HRV) is an indicator of  heart failure progression and mortality.  Heart rate increases and decreases with each breath in normal physiology termed respiratory sinus arrhythmia (RSA). RSA is high in young, healthy people, and is lost in cardiovascular disease.

Ceryx Medical, a company based in Cardiff, Wales is developing an implantable cardiac pacemaker that reintroduces respiratory-modulated pacing with the intention to improve cardiac output as a treatment for heart failure.

A preclinical study in an ovine heart failure model showed that reintroducing respiratory-modulated pacing in heart failure results in a dramatic improvement in directly recorded cardiac output. In addition, RSA pacing reduces apnea incidence and re-models cardiomyocyte morphology.

In November 2024 Ceryx conducted a First-In-Human Study of the technology using an external Osypka pacemaker with its rate modulated by the Cysoni RSA device.  The study is being conducted in New Zeland, Australia, and the UK on post-CABG patients with HFrEF who require temporary pacing.

Regarding that weird-looking double-header IPG device shown on their website – I don’t believe that it’s even a conceptual idea (the image is obviously just a PhotoShop flip and blend of the same generic IPG picture). I would think that an IPG implementing the Cysoni pacing scheme would look just like a dual-chamber pacemaker that would use a respiration signal derived from an impedance sensor to dynamically modulate the pacing rate Ceryx’s algorithm.

Impulse Dynamics®’ INTEGRA-D Trial Completes Efficacy Phase for CCM-D System

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

Image credit: Impulse Dynamics Note: The OPTIMIZER Integra CCM-D System is an investigational device. It is not available for sale in the United States.

Yesterday, Dr. Niraj Varma, on behalf of the INTEGRA-D investigators, presented data for the efficacy phase of the clinical trial of the combined Cardiac Contractility Modulation/Defibrillator System (OPTIMIZER Integra CCM-D). The results were presented at a late-breaking clinical trial session at the 2025 Heart Rhythm conference in San Diego, CA.

This is a very important step for Impulse Dynamics – the company for which I serve as CTO and Executive VP – towards bringing to market a single device which combines our proprietary CCM therapy for the treatment of HF symptoms with implantable cardioverter defibrillator (ICD) therapy.

In the trial, the OPTIMIZER Integra CCM-D device successfully converted 100% of ventricular fibrillation (VF) induced in 100 consecutive patients, meeting the primary efficacy endpoint.  The Company’s press release is available here.

Note: The OPTIMIZER Integra CCM-D System is an investigational device. It is not available for sale in the United States.

Interesting Paper on Dorsal Root Ganglion Stimulation to Increase Diuresis

Posted on by Posted in Diuresis, Heart Failure (CHF), Medtronic
From Pawel et al., "Electrical Diuretics: Dorsal Root Ganglion Stimulation to Increase Diuresis,"Neuromodulation: Technology at the Neural Interface, Volume 27, Issue 7, 2024, Pages 1208-1217

From Pawel et al., “Electrical Diuretics: Dorsal Root Ganglion Stimulation to Increase Diuresis,”
Neuromodulation: Technology at the Neural Interface, Volume 27, Issue 7, 2024, Pages 1208-1217

Scientists from Medtronic’s Bakken Research Center in The Netherlands, along with collaborators from Poland just published a paper on increasing diuresis through Dorsal Root Ganglion (DRG) stimulation as a potential therapy for heart failure.

The paper “Electrical Diuretics: Dorsal Root Ganglion Stimulation to Increase Diuresis” was published in Neuromodulation: Technology at the Neural Interface (Volume 27, Issue 7, 2024, Pages 1208-1217).  A summary abstract is available from Elsevier.  It explains:

“Stimulation of diuresis is an essential component of heart failure treatment to reduce fluid overload. Over time, increasing doses of loop diuretics are required to achieve adequate urine output, and approximately 30% to 45% of patients develop diuretic resistance. We investigated the feasibility of affecting renal afferent sensory nerves by dorsal root ganglion neurostimulation as an alternative to medication to increase diuresis.”

The study was conducted in 7 pigs and showed that electrical stimulation (bDRG) at T11 and/or T12 caused an average diuresis increased 20% to 205% compared with no stimulation.   The authors report that side effects such as motor stimulation were mitigated by decreasing current or terminated spontaneously without intervention, and that there was no negative effect on acute kidney function because blood electrolyte concentrations remained stable.

Fire1’s Inferior Vena Caval Size Monitor

Posted on by Posted in FIRE1, Heart Failure (CHF), IVC Monitoring
Fire 1 Inferior Vena Caval Size Monitoring

Image Credit: Fire 1

FIRE1 is an Ireland-based company developing an implantable Inferior Vena Cava (IVC) size sensor for heart failure monitoring.   The FIRE1 System is a device designed to directly measure a patient’s volume status by measuring the IVC, which is the largest vein in the body where most fluid is stored.

The FIRE1 sensor is implanted at the abdominal level and works by measuring the size of the IVC to give a marker of the amount of fluid in the body. High levels can increase the risk of breathing difficulties and a build-up of fluid in the lungs which lead to an emergency hospital admission. The patient wears a belt reader around the abdomen for around a minute a day to take a reading from the sensor and the data is sent to the patient’s clinical team at the hospital. The system is designed to alert whenever the patient’s condition deteriorates.

In March 2024, FIRE1 announced that it has completed patient enrollment in the U.S. Early Feasibility Study (FUTURE-HF2) of its system. Results presented at CRF’s THT showed that all enrolled patients (n=8) met their safety and effectiveness endpoints.

Update on Device Based Therapies in Heart Failure published by HFSA

Posted on by Posted in Abbott, Baroreceptor Stimulation, Berlin Heals, Biotronik, Boston Scientific, Cardiac Contractility Modulation, Cardiac Neuromodulation, Cardiac Pacing, Cardiac Stimulation (other), CardioMEMS, Cardioversion/Defibrillation, Circulatory Support, CVRx, Edwards, Endotronix, Heart Failure (CHF), Impulse Dynamics, Medtronic, Microcurrent, Respicardia, Ventricular Assist Device, Viscardia
From: HFSA Scientific Statement: Update on Device Based Therapies in Heart Failure, ESTEP, JERRY D. et al., Journal of Cardiac Failure, 2024

From: HFSA Scientific Statement: Update on Device Based Therapies in Heart Failure, ESTEP, JERRY D. et al., Journal of Cardiac Failure, 2024

The Heart Failure Society of America (HFSA) published today a new Scientific Statement titled “Update on Device Based Therapies in Heart Failure.”  The statement was published online in the Journal of Cardiac Failure (JCF).

This statement discusses how novel device-based therapies, including CCM, BAT, and remote monitoring may bridge current gaps in HF treatment and outcomes.  The statement also proposes a clinical pathway to implement FDA approved device-based therapies that align with current HF management workflow.

 

 

FDA approves Endotronix’s Cordella PA Sensor

Posted on by Posted in Endotronix, Heart Failure (CHF), Sensors

Endotronix announced that it received FDA’s PMA approval for its Cordella™ Pulmonary Artery (PA) Sensor System for the treatment of NYHA class III heart failure patients. According to Endotronix, “The Cordella platform is the first and only PA pressure-guided platform to offer comprehensive patient management using daily PA pressure and vital signs from home to guide therapeutic management and improve patient outcomes.”

According to the announcement:

“Cordella is a proactive HF management platform that delivers daily PA pressure and other vital data via an implantable sensor and user-friendly, non-invasive health tools, respectively, to a managing HF clinician for remote patient care. This information guides clinical decision-making and medication dosing while enhancing the adoption of guideline-directed medical therapy (GDMT) to reduce congestion and improve outcomes. Regulatory approval was based on the PROACTIVE-HF trial, which demonstrated a markedly low 0.159 rate of heart failure hospitalization and all-cause mortality at 6 months.”

China’s Evolving Domestic AIMD Industry

Posted on by Posted in Aerospace Taixin Technology, AIMD Business, Bradycardia, Brain Stimulation, Cardiac Contractility Modulation, Cardiac Pacing, Cardioversion/Defibrillation, CH Biomedical (Tongxin Medical Equipment), Circulatory Support, Cochlear Stimulation, Core Medical Technology, CoreRhythm, General Stim, Genlight, Hearing Impairment, Heart Failure (CHF), Leadinno Medical Valley, Lepu Medical, Lifetech Scientific, Microport, Nerve Blocking, Nurotron, Nystagmus, Pain, Parkinson's Disease, PINS Medical, PNS, Qinming Medical, Rectus Muscle Stimulation, Rishena Medical, Rocor Medical Technology, Sacral Root Stimulation, Sceneray, Seeneuro, Singular Medical, Sneuro, Spinal Cord Stimulation, Super Vision, Tachycardia, Vagus Nerve Stimulation, Yongrenxin

AIMDs made in China www.implantable-device.com

The 2015 “Made in China 2025” and subsequent domestic development initiatives have significantly benefited Chinese medical device manufacturers.  The 2015 plan  prioritized the expansion of high-tech device production with the goal of supplying 70% of China’s device market by 2025.   More recently, in 2021, the Chinese government issued the 14th  five-year plan (2021–25) that aims at making at least six Chinese companies reach the top 50 revenue-making medical device companies globally.

I was recently chatting with Victor Pikov at the First AIMD Workshop, and he mentioned that in the last couple of years the number of Chinese AIMD manufacturers have grown from 5 to over 10.  I was really surprised about the progress that China has made in the AIMD field, so this blog expands on the list of Chinese AIMD companies that Victor compiled and kindly shared with me. Continue reading→

Impulse Dynamics Completes $136M Financing Round

Posted on by Posted in AIMD Business, Cardiac Contractility Modulation, Cardiac Pacing, Cardioversion/Defibrillation, David Prutchi's Portfolio, Heart Failure (CHF), Impulse Dynamics

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.”

Presenting Keynote “AIMD-based Therapies of Heart Failure” at LASCAS 2024

Posted on by Posted in AIMD Business, Cardiac Contractility Modulation, Cardiac Neuromodulation, Cardiac Pacing, Cardiac Stimulation (other), Cardioversion/Defibrillation, Circulatory Support, David Prutchi's Portfolio, Heart Failure (CHF), Hypertension, My Portfolio, Vagus Nerve Stimulation

LASCAS Keynote

I’ll be presenting the keynote “AIMD-based Therapies of Heart Failure” at the First Workshop on Active Implantable Medical Devices dedicated to understanding the trends and challenges in bioelectronic medicine.

For the complete announcement of the workshop with some great talks by Rikky Muller (UC Berkeley), Pedro Arzuaga (Impulse Dynamics), Marcelo Barú (Biotronik), Federico De Mula (Integer), and Victor Pikov (Medipace) click here:  AIMD Workshop LASCAS 2024 Program.

 

Endotronix Submits PMA Application for the Cordella PA Sensor

Posted on by Posted in Endotronix, Heart Failure (CHF), Sensors

Endotronix, announced the submission of a Premarket Approval (PMA) application for its Cordella™ Pulmonary Artery (PA) Sensor System to the FDA.

According to the announcement:

“Cordella is an innovative HF patient management platform that delivers proactive PA pressure data and non-invasive vital health data for comprehensive heart failure management at home. Its user-friendly devices securely transmit daily health information to the managing clinician, supporting optimal dosing of guideline-directed medical therapy (GDMT) to reduce congestion and engaging patients with trended health data to enable healthy lifestyle choices.”

In April 2023 Endotronix completed the enrollment of its PROACTIVE-HF pivotal study.  Primary endpoint data from the trial is expected to support the PMA Application.

 

Lepu Medical Granted Chinese “Green Channel” for Implantable Cardiac Contractility Modulator (ICCM)

Posted on by Posted in Cardiac Contractility Modulation, Heart Failure (CHF), Impulse Dynamics, Lepu Medical

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

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

OPTIMIZER Smart Mini whole-body MRI

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

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.

Continue reading→

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.