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

Category Archives: Cardiac Pacing

Cardiac pacemakers

Devices Implants Limited pacemaker brochures

Posted on by Posted in Bradycardia, Cardiac Pacing, Devices Implants Limited, History, Museum
Pacemaker by Devices Implants Ltd

From brochure of Devices Implants Limited axilla pacemaker

Devices Implants Limited of Welwyn Garden City in Hertfordshire was the only British manufacturer of implantable pacemakers.  It operated between December 1974 and June 1983  when it was acquired by Intermedics.

Devices Implants Ltd. manufactured a number of pacemakers that were developed in collaboration with the St George’s Hospital, London.

There is very little information available on their 1960s devices, so I was glad when I found brochures for two of the Devices Implants pacemakers between the archives of the Clarence Historical Society.

Devices Implants Ltd pacemakers brochure

Impulse Dynamics Completes Enrollment of Pivotal Trial for CCM-D® HF System

Posted on by Posted in Bradycardia, Cardiac Contractility Modulation, Cardiac Pacing, 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’m an Exec VP and CTO, announced today the completion of enrollment in the INTEGRA-D trial of the CCM-D system intended for the treatment of heart failure.

From the press release:

“The company successfully completed enrollment in the INTEGRA-D™ Pivotal Trial. This marks a significant milestone in the journey to introduce the CCM-D® HF System, the world’s first device combining Impulse Dynamics®’ proprietary CCM® therapy for the treatment of HF symptoms with lifesaving, implantable cardioverter defibrillator (ICD) therapy. The trial’s initial results, including 100 percent defibrillation success in the efficacy cohort, were presented as a late-breaking clinical trial at Heart Rhythm 2025 and support a forthcoming PMA submission to the FDA. This milestone advances thepotential approval of a first-of-its-kind dual therapy that is designed to address both sudden cardiac death and chronic HF symptoms.”

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.

History: Mennen Medical and the First Israeli Pacemakers 1976-1980

Posted on by Posted in Bradycardia, Cardiac Pacing, Greatbatch Medical (Power), History, Mennen Medical (1976-1980), Museum, Omikron Scientific (1979-1985)
Mennen Medical’s Model 801 pacemaker. From: https://www.makash.org.il/sy/jerusa_book.pdf

Mennen Medical’s Model 801 pacemaker. From: Dr. Shmuel Yerushalmi’s memoir at www.makash.org.il/sy/jerusa_book.pdf

I spent the year-end holidays in Israel and had the pleasure of speaking with some of Mennen Medical’s and Omikron Scientific’s first employees regarding the efforts that these companies made in the late 1970s and early 1980s towards the development and manufacture of pacemakers in Israel.

Benny Kiron, who joined Mennen Medical in 1976 as a product designer, referred me to Dr. Shmuel Yerushalmi’s memoir at www.makash.org.il/sy/jerusa_book.pdf, from which I was finally able to understand the origin of Mennen Medical’s pacemaker project, as well as its relationship with Omikron Scientific.

Dr. Shmuel Yerushalmi was born in Brasil and emigrated to Israel in 1956. In 1976, while still pursuing his doctorate at the prestigious Weizmann Institute, he started working at the Israeli subsidiary of Mennen-Greatbatch of Clarence, NY.

The Mennen-Greatbatch partnership was dissolved when Wilson Greatbatch decided to concentrate on lithium battery development, and the Israeli company became a subsidiary of Mennen Medical, where an implantable pacemaker project was started.

RF-powered pacemaker developed by the Weizmann Institute and meant for production by Elta. From: https://www.makash.org.il/sy/jerusa_book.pdf

RF-powered pacemaker developed by the Weizmann Institute and meant for production by Elta. From: Dr. Shmuel Yerushalmi’s memoir at www.makash.org.il/sy/jerusa_book.pdf

Shmuel Yerushalmi had worked on the development of an RF-powered pacemaker while still a technician at the Weizmann institute, so his experience was tapped at Mennen Medical to lead the development of a VVI pacemaker powered by a Greatbatch lithium battery. The project was supported by Israel’s Chief Scientist Office and the BIRD (Israel-US Binational Industrial Research and Development) Foundation .

PCBA of Mennen Medical’s Model 801 pacemaker. Device was kindly gifted to me by Koby Kamin. ©2025 David Prutchi.

PCBA of Mennen Medical’s Model 801 pacemaker. Device was kindly gifted to me by Koby Kamin. ©2025 David Prutchi.

Continue reading→

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.

 

 

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.

 

Medtronic Receives CE Mark for its Micra AV2 and VR2 Leadless Pacemakers

Posted on by Posted in Bradycardia, Cardiac Pacing, Medtronic
Medtronic's AV2 and VR2 leadless pacemakers

Image Credit: Medtronic

Medtronic announced that it received CE mark approval for its next-generation Micra AV2 and Micra VR2  leadless pacemakers.

According to the press release:

“Micra AV2 and Micra VR2, the world’s smallest pacemakers, provide longer battery life and easier programming than prior Micra pacemakers, while still delivering the many benefits of leadless pacing such as reduced complications compared to traditional pacemakers.

With approximately 40% more battery life compared to previous generations, Medtronic projects the battery life of Micra AV2 and Micra VR2 is nearly 16 and 17 years, respectively. This means more than 80% of patients who receive a Micra may only require one device for life.

This CE Mark milestone follows U.S. Food and Drug Administration approval for the Micra AV2 and VR2 devices in 2023.

In addition to size and longevity benefits, Micra devices are also the only leadless pacemakers with remote monitoring capabilities, which allow a doctor or clinic to check on a patient’s heart device without the need for a patient to travel to their clinic for an in-person appointment. Other patient benefits of remote monitoring may include a reduction in hospitalizations and increase in sense of security.”

Chinese Pacemakers by Qinming Originated in Delaware

Posted on by Posted in Bradycardia, Cardiac Pacing, Cardio-Pace, History, Qinming Medical
Pacemakers by Qingming (China)

Image Credit: Qingming

Cardio-Pace Medical, Inc was incorporated in Delaware on April 20, 1981 to develop, manufacture, and market its proprietary Durapulse(TM) cardiac pacemaker and accessory products. Although Cardio-Pace achieved sales of its pacemakers, it did not achieve profitability.  As a result, they suspended manufacturing the cardiac pacemaker in 1990. During 1985, Cardio-Pace entered into an agreement with Qinling Semiconductor to establish Qinming Medical, Inc., a Sino-American joint venture in Baoji, China, for the manufacture and distribution of cardiac pacemakers and accessory products. In 1992, Cardio-Pace sold its 49% interest in the joint venture to Qinming.

In 2010, Lepu Medical of Beijing purchased a 30.46 percent stake in Qinming as part of its efforts to forge an integrated Chinese cardiovascular products company. In 2013, Lepu completed the acquisition of Shaanxi Qinming Medical Instruments Co., Ltd.

Around that time, Qinming developed the QM7211, which was the first domestically developed dual-chamber rate-responsive pacemaker in China.  Its clinical study to evaluate it for non-inferiority against a Biotronik Talos pacemaker was successfully completed in 2015.

Today, Qinming is Lepu’s subsidiary in charge of the development, manufacture, and marketing of pacemaker products.  Their line includes single- and dual-chamber devices, as well as passive and active-fixation leads.

 

Orchestra Biomedical Receives Approval to Start BACKBEAT IDE

Posted on by Posted in BackBeat Medical, Bradycardia, Cardiac Pacing, Hypertension, Medtronic, Orchestra Biomedical
Orchestra Biomed Backbeat therapy for hypertension in patients indicated for dual-chamber pacing

Image Credit: Orchestra BioMed

Orchestra Biomedical announced that it has received FDA’s approval (Sep 19, 2023) to initiate its BACKBEAT (BradycArdia paCemaKer with atrioventricular interval modulation for Blood prEssure treAtmenT) IDE study for evaluating the efficacy and safety of atrioventricular interval modulation (“AVIM”) therapy (also known as BackBeat CNT™) for treating hypertensive patients who are indicated for a dual-chamber cardiac pacemaker.

Orchestra and Medtronic formed a strategic collaboration for the development and commercialization of AVIM therapy for hypertensive pacemaker patients in July 2022. Under the collaboration, Medtronic is providing Orchestra BioMed with development, clinical, and regulatory support for the BACKBEAT global pivotal study, which Orchestra BioMed is sponsoring. If approved, Medtronic will have exclusive global rights to commercialize AVIM-enabled pacing systems for this target population.

FDA Approves Abbott’s Aveir Dual-Chamber Leadless Pacing System (July 2023)

Posted on by Posted in Abbott, Bradycardia, Cardiac Pacing
AVEIR dual-chamber leadless pacing system www.implantable-device.com

Image Credit: Abbott

On July 5, 2023 Abbott announced that the FDA had approved the AVEIR™ dual chamber (DR) leadless pacemaker system, the world’s first dual chamber leadless pacing system.

According to the press release:

Through Abbott’s proprietary i2i™ communication technology, AVEIR DR devices provide synchronized or coordinated cardiac pacing between two leadless pacemakers based on the person’s clinical needs. The i2i technology utilizes high-frequency pulses to relay messages via the naturally conductive characteristics of the body’s blood between each leadless pacemaker. To support dual chamber therapy, each implant communicates beat-to-beat with a paired, co-implanted device. This conductive communication is critical, because it uses far less battery current than inductive, radio frequency or Bluetooth® communication which are other alternatives used in implantable medical devices or traditional pacemakers.

Roughly one-tenth the size of a traditional pacemaker, the AVEIR DR leadless pacing system is made up of two devices – the previously-approved AVEIR VR single chamber device, which paces the right ventricle, and the now-approved AVEIR AR single chamber device, which paces the right atrium. The AVEIR DR system incorporates Abbott’s novel i2i technology, which solves a significant engineering challenge by offering beat-to-beat communication between the two leadless pacemakers.

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→

Abbott Implants World’s First Dual-Chamber Leadless Pacemaker

Posted on by Posted in Abbott, Bradycardia, Cardiac Pacing

Image Credit: Abbott

Abbott announced today the world’s first patient implants of a dual-chamber leadless pacemaker system as part of its AVEIR DR i2i™ pivotal clinical study.  Abbott’s “i2i technology” is used to provide beat-by-beat communication between two leadless pacemakers, one positioned in the right ventricle and one positioned in the right atrium to allow for true dual-chamber leadless pacing.

The Aveir DR i2i study is a prospective, multicenter, international, single-arm, pivotal investigational study designed to evaluate the clinical safety and efficacy of the Aveir DR leadless pacemaker in patients who were indicated for a DDD(R) pacemaker.   The study plan is to enroll up to 550 patients from up to 80 sites, and all patients will be followed for a minimum of 12 months post-implant.