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

Category Archives: Treated Conditions

Implantable Devices to treat specific conditions

History: Telectronics’ P10 hermetically-sealed pacemaker with mercury cells

Posted on by Posted in Bradycardia, Cardiac Pacing, History, Museum, Telectronics (1965-1995)
Telectronics P10B Pacemaker

(c)2026 David Prutchi PhD

In the 1960s and early 1970s, pacemakers powered by mercury/zinc cells had to be enclosed in epoxy because the cells produced hydrogen, which could safely diffuse outward through the epoxy’s permeability to hydrogen.

However, epoxy encapsulation also allowed water molecules to penetrate into the battery area and electronic assembly, often causing their failure.

In 1971, Australian pacemaker company Telectronics produced the model P8; the first hermetically sealed pulse generator in a titanium case. The hydrogen problem was taken care of by means of a
hydrogen absorbent inside the case, and the high welding temperature needed to seal the case, without damaging the contents, by a carefully worked out combination of fast welding and external heat sinking and cooling.

The P10 model shown here was based on the P8, but incorporated a silicone elastomer coating to limit the area of the indifferent electrode to prevent pectoral muscle stimulation.

New PACE Paper Online: Our Project Reconstructing the Earliest Battery-Powered Implantable Pacemakers

Posted on by Posted in Bradycardia, Cardiac Pacing, David Prutchi's Portfolio, Elema-Schonander (-1959), History, Museum, My Portfolio

(c) 2026 David Prutchi and Daniel Villamil. All rights reserved

I’m pleased to share that our paper is now available online in PACE: “Pioneering Rhythm Management: A Design Analysis of the Earliest Battery-Powered Implantable Pacemakers.”

Over the past year, my colleague Daniel Villamil and I have pursued this as a hobby project, combining historical research with hands-on engineering. We analyze the earliest battery-powered implantable pacemakers developed independently by Rune Elmqvist (1958) and Wilson Greatbatch (1960), and we reconstruct faithful working replicas to explore the design tradeoffs and constraints that shaped these devices.

The print version will be published soon. The online version is here: http://doi.org/10.1111/pace.70127 (note: the article is not open access).

 

 

Coherence Neuro’s SOMA electroceutical implant intended to monitor and treat cancer

Posted on by Posted in Brain Stimulation, Cancer, Coherence Neuro, EEG Monitoring

Image Credit: Coherence Neuro

Coherence Neuro was originally incorporated as Opto Biosystems Ltd in in Cambridge, UK on March 17, 2022 by Drs. Ben Woodington and Elise Jenkins. It describes itself as a medical technology company developing implantable neurotechnology that can record electrical activity and deliver targeted electrical modulation as a new bioelectronic approach to cancer care. Their flagship system is SOMA-1, presented as an MRI-compatible, minimally invasive brain–computer interface intended to be implanted during existing neurosurgery to monitor and treat gliomas in real time.

A Neurofounders article, described how Coherence wants to measure neural activity patterns, specifically the rate and structure of neuronal firing, and use those signals to infer how the tumor is interacting with surrounding neural circuits and how it is changing over time. The stated clinical vision is that continuous sensing could provide clinicians with higher-temporal-resolution information about progression and response than current workflows, which often depend on scans spaced months apart.

The same piece lays out three therapeutic “lanes” for stimulation:

  • Direct effects on tumor cells. Coherence argues that because fundamental cellular behaviors tied to growth involve bioelectric phenomena, targeted electrical modulation might suppress proliferation, in effect pushing tumor cell behavior in a less growth-favorable direction.
  • Modulation of the tumor microenvironment and neural inputs. A second approach is to influence the local ecosystem around the tumor, including neuron-to-tumor interactions and downstream signaling. The article highlights the idea that neural activity can promote tumor growth via neuromodulatory signaling, and therefore that disrupting or reshaping those activity patterns could reduce pro-growth cues.
  • Immunomodulation. The third pathway is to use stimulation to shift local immune activity in and around the tumor. In the Neurofounders account, the aim is to tune immune responsiveness in a way that could, at least in principle, make some tumors more amenable to immunotherapy strategies.

Coherence Neuro believes that the same concepts could be applied to cancer in other parts of the body, and they mention in their website that they have started to investigate the use of SOMA in pancreatic cancer.

Their published patent application is understandably high level, and it does not clearly identify the specific neural biomarker they plan to track or the stimulation patterns they believe will meaningfully disrupt tumor progression. I am interested to see how this translates in practice, but I will look to controlled clinical data before drawing conclusions.

Boston Scientific buying urinary incontinence treatment device maker Valencia Technologies

Posted on by Posted in AIMD Business, Boston Scientific, Incontinence, Tibial Nerve Stimulation, Valencia Technologies

 

Valencia Technologies eCoin

Image Credit: Valencia Technologies

On March 1, 2022 FDA approved Valencia Technologies’ eCoin Peripheral Neurostimulator System to stimulate the tibial nerve to treat Urge Urinary Incontinence. The eCoin system delivers electrical pulses to the tibial nerve in 30-minute sessions based on a fixed schedule. A healthcare provider can adjust the level of stimulation based on each patient’s sensitivity and needs, using the remote control.

Boston Scientific today announced it has entered into a definitive agreement to acquire Valencia Technologies Corporation.  Terms of the acquisition have not been disclosed.

Biotronik study reveals utility of remote monitoring and remote programming in SCS

Posted on by Posted in Biotronik, Pain, Spinal Cord Stimulation
Biotronik Prospera IPG

Image Credit: Biotronik

In 2023 Biotronik received FDA approval for its Prospera™ Spinal Cord Stimulation System to treat chronic, intractable pain. The system features connectivity with Biotronik’s Embrace One™, which the company claims to provide automatic, objective, remote daily data transmission for true proactive care management.

A new study using the Prospera® SCS system was published in Neuromodulation supporting the adoption of real-time remote monitoring as a new standard for long-term SCS device management.

According to the press release, the study demonstrates that:

“…automatic, daily remote monitoring of spinal cord stimulation (SCS) devices enables the first real-time visibility into post-implant therapy use, including the identification of “virtual explants” — patients with prolonged device inactivity who have not undergone surgical removal. In the study, patients using the Prospera® SCS system — the only SCS device with automatic, objective, daily remote monitoring and remote programing — maintained high rates of therapy use and low explant rates.”

 

 

 

In Memoriam: Dr. Shmuel Yerushalmi ז״ל (1934–2025)

Posted on by Posted in Bradycardia, Cardiac Pacing, History, Mennen Medical (1976-1980), News, Omikron Scientific (1979-1985)

Dr. Shmuel Yerushalmi ז״ל (1934–2025)
Pacemaker Pioneer and Builder of Israel’s Biomedical Industry

I was deeply saddened to learn of the passing of Dr. Shmuel Yerushalmi ז״ל, a pacemaker pioneer whose work has been central to my research on the early history of implantable cardiac devices in Israel, and whom I had planned to visit during my current stay in the country.

Dr. Yerushalmi’s death marks the loss of one of the key figures in the formative period of Israel’s implantable medical device industry.  He was an engineer whose career bridged academic research, industrial development, and the practical challenges of bringing life-sustaining technology to patients. Continue reading→

History: Nuclear Pacemakers in Small-Town Pennsylvania: The Coratomic Story

Posted on by Posted in Biocontrol Technology, Bradycardia, Cardiac Pacing, Coratomic, Nuclear Batteries

Coratomic lithium pacemakers 1970s

Coratomic, Inc. was a cardiac device manufacturer based in Indiana, Pennsylvania. It was one of a handful of American firms that developed and marketed plutonium-238 radioisotope-powered pacemakers in the 1970s. Coratomic grew out of the Allegheny General Hospital nuclear-pacemaker program led by George J. Magovern, Sr., with David L. Purdy as the key technical founder and executive, and Nicholas P. D. Smyth as a principal clinical collaborator.

The initial enthusiasm for Pu-238 pacemakers waned as regulatory complexity, public concern about implanted nuclear material, and the improving longevity of lithium-chemistry cells converged. Like the other pacemaker companies of the time, Coratomic abandoned the development of radioisotope-powered devices and concentrated on lithium-powered pacemakers.

A few months ago, I was contacted by Tim Vore, a resident of Indiana, Pennsylvania, where Coratomic pacemakers were manufactured. He had found a few demo models at an estate sale, tucked inside an old, beaten-up desk in an attic. I acquired these from him (with his permission to tell the story of where he had found them).

Upon receiving them, I x-rayed the units and confirmed that they are all weighted mechanical dummies, except for one of the Ovalith units in which half of the shell had been cut open and the pacemaker’s internals were encapsulated to display their microcircuit (still using miniature, albeit discrete, components) and battery. The collection also included a few setscrew wrenches and hybrids encapsulated in dual-in-line metallic chip carriers.

In 1986, Coratomic changed its name to Biocontrol Technology, Inc., exited the pacemaker business, and focused increasingly on other medical technologies, notably a non-invasive glucose monitor.

A 2002 Pittsburgh Tribune-Review article states that “Bico, formerly known as Biocontrol Technology Inc., and before that, Coratomic Inc.” had accumulated large losses. Not surprisingly, in March 2003 Bico Inc. filed for Chapter 11 bankruptcy protection in federal court in Pittsburgh. As part of its court-approved reorganization, it later merged with cXc Services, Inc. – a small, privately held Delaware start-up created in 2003 to commercialize a “WebPhone” videophone product – marking a complete departure from its origins in implantable cardiac devices.

CMS issues favorable National Coverage Decision (NCD) for CCM® Therapy

Posted on by Posted in Cardiac Contractility Modulation, Heart Failure (CHF), Impulse Dynamics
Impulse Dynamics OPTIMIZER Smart Mini IPG by Impulse Dynamics

Image Credit: Impulse Dynamics

Impulse Dynamics, the company where I serve as Executive VP and CTO announced that the Centers for Medicare and Medicaid Services issued yesterday a favorable National Coverage Decision (NCD) memo for Cardiac Contractility Modulation (CCM®) Therapy.  The decision was supported by the American College of Cardiology, the Heart Failure Society of America, and the Heart Rhythm Society.

According to the announcement:

“CCM® therapy for heart failure (HF) patients is one of only five therapies selected for the Transitional Coverage for Emerging Technologies (TCET) pathway in 2025. This determination marks a transformative milestone for HF patients and their providers, validating that CCM® therapy is no longer experimental or investigational.”

Boston Scientific acquires Nalu for $533M

Posted on by Posted in Boston Scientific, Nalu, Pain, PNS, Spinal Cord Stimulation

Image Credit: Nalu

Nalu Medical, Inc. is a privately held, early-stage start-up based in Carlsbad, California. They developed the Nalu micro-Implantable Pulse Generator (mIPG) system, which consists of a fully-featured, battery-free, miniaturized IPG, which is powered by an externally worn Therapy Disc and controlled through a smartphone based remote control app. The Nalu Neurostimulation System is currently FDA-cleared for Spinal Cord Stimulation (SCS) and Peripheral Nerve Stimulation (PNS) indications.

On October 17 Boston Scientific announced it has entered into a definitive agreement to acquire Nalu Medical, Inc. for an upfront cash payment of approximately $533 million for the remaining equity not owned by Boston Scientific (which has been a strategic investor since 2017).

 

FDA approves Medtronic’s Altaviva™ tibial stimulator for urge urinary incontinence

Posted on by Posted in Incontinence, Medtronic, Tibial Nerve Stimulation
Altaviva tibial neuromodulation IPG

Image credit: Medtronic

On September 19, 2025, Medtronic announced that it had received FDA approval for its Altaviva implantable tibial nerve neurostimulator for the treatment of urge urinary incontinence (UUI).  The device is inserted near the ankle during a minimally invasive procedure that doesn’t require sedation or imaging, and is then activated to deliver therapy automatically.

The device is powered by a rechargeable battery based on Medtronic’s proprietary Overdrive™ battery technology with an expected longevity of 15 years.  According to Medtronic, the Altaviva IPG only needs to be recharged 1–2 times per year under standard therapy settings, with each session taking about 30 minutes when properly positioned.

Daré Bioscience

Posted on by Posted in Contraception, Daré Bioscience, Drug Delivery

Dare logo

MicroCHIPS implantable programmable pump for the treatment of osteoporosis

Image Credit: MicroCHIPS, Inc.

Daré Bioscience is a female-health-focused biotech company conducting end-to-end clinical development in ob-gyn.  They are developing the “DARE-LARC1” smart implant, a programmable drug delivery system for long-acting reversible contraception (LARC) and other long-term therapeutic uses like diabetes and obesity. This implant uses programmable micro-reservoirs to deliver precise doses for months to years from a single device, features wireless control with smartphone integration, can have its software updated remotely, and is powered by a battery designed to last up to 20 years. According to the company:

“DARE-LARC1 is a preclinical-stage investigational, long-acting reversible contraceptive (LARC) utilizing a next-generation programmable drug delivery device to administer levonorgestrel, the active pharmaceutical ingredient in a number of FDA-approved birth control methods, for an extended period without requiring day-to-day effort.”

Daré announced that it had received a $4.0 million non-dilutive funding installment under its multi-year grant agreement to support development of DARE-LARC1. This brings the total received to approximately $41.8 million of the up to approximately $49 million in committed grant funding for nonclinical development, IND-enabling studies, and preparation for submission of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA).

 

Edwards acquires remaining 48% of Vectorius Medical

Posted on by Posted in Heart Failure (CHF), Sensors, Vectorius Medical

Image Credit: Vectorius Medical

Tel Aviv-based Vectorius Medical developed the V-LAP implantable device for the measurement of Left Atrial Filling Pressure (LAP). The device is implanted in the left atrium, has no battery, and is able to communicate with an external interrogator from deep within the body.

Edwards acquired a 52% stake in 2023.  Earlier this month Edwards acquired the remaining 48% stake at a valuation of $497 million. Vectorious will operate as a wholly owned subsidiary of Edwards.

Coloplast/Nine Continents Medical publishes pilot data on Intibia™ device for treatment of urgency urinary incontinence

Posted on by Posted in Coloplast, Incontinence, Nine Continents Medical, Tibial Nerve Stimulation
Intibia

From: https://doi.org/10.1016/j.neurom.2025.01.013

My colleague Nicolás Barabino of Adcorpus called my attention to a recent publication by Nine Continents Medical reporting on Coloplast’s Intibia™ System, which is an implantable tibial nerve stimulator in subjects with urgency urinary incontinence.

Nine Continents Medical was founded in Livermore, CA in 2014.  It was acquired in 2020 by ostomy company Coloplast acquired  for $145M upfront cash payment and an additional contingent future milestone payment.  The acquisition gave Coloplast an early-stage implantable tibial nerve stimulation treatment for over-active bladder.

The Intibia™ implantable tibial nerve stimulator (ITNS) is a miniaturized, self-powered unit placed in the lower leg under local anesthesia during a short, minimally invasive procedure.  It is claimed to have long battery life, with no need for patient compliance in therapy. Continue reading→

Nyxoah Receives FDA Approval for Genio® System for Treating Obstructive Sleep Apnea

Posted on by Posted in Muscular Stimulation, Nyxoah, Obstructive Sleep Apnea, Sleep Apnea
Nyxoah's miniature implant Genio implantable bilateral hypoglossal nerve stimulation for treatment of Obstructive Sleep Apnea

Nyxoah’s Genio implantable bilateral hypoglossal nerve stimulation for treatment of Obstructive Sleep Apnea
Image Credit: Nyxoah

I previously described efforts by Nyxoah, which was founded in 2009 by Robert Taub and Dr. Adi Mashiach in Mont-Saint-Guibert, Belgium, to develop neurostimulation treatments focused for Obstructive Sleep Apnea.

Last week (August 8, 2025), Nyxoah announced that FDA had approved its Genio System to treat a subset of patients with moderate to severe OSA with an Apnea-Hypopnea Index (AHI) of greater than or equal to 15 and less than or equal to 65.

Nyxoah developed a tiny, battery-less implantable neurostimulator that can electrically control the nerves of the tongue and so prevent airway blockage during sleep. The implant is powered and controlled by a disposable external adhesive patch. Every evening the OSA sufferer uses a new disposable patch that carries an “Activation Chip” that is positioned every night by the patient under the chin. The Activation Chip has its own battery and has enough energy to wirelessly activate the implanted neurostimulator for a full night sleep session.

According to the press release:

“The Genio system’s FDA approval was supported by the high-quality, differentiated safety and efficacy data from the Company’s DREAM pivotal trial. The DREAM study met both its primary and secondary endpoints demonstrating an AHI responder rate of 63.5% and an Oxygen Desaturation Index responder rate of 71.3%, with an overall median AHI reduction of 70.8%. Additionally, 82.0% of all DREAM subjects saw their AHI scores drop below 15 or lower.

Importantly, the DREAM study demonstrated that Genio is efficacious regardless of a patient’s sleeping position and, to our knowledge the only therapy with such clinical evidence in a large, multicenter, prospective clinical study using data from a full night polysomnography. This is a critical differentiator as on average, people sleep in a supine position between 35% and 40% of the night. The DREAM study measured position-specific outcomes and demonstrated a 66.6% median AHI reduction while patients slept in a supine position despite the fact that the number of airway obstructions can double in this position. This reduction compares favorably to the 71.0% reduction in AHI shown while patients slept in a non-supine position.”

BerlinHeals publishes results on from the C-MIC II trial of microcurrent therapy for heart failure

Posted on by Posted in Berlin Heals, Cardiac Stimulation (other), Heart Failure (CHF), Microcurrent
Berlin Heals C-MIC

C-MIC Device. Image Credit: Berlin Heals

Berlin Heals recently published results of its open-label randomized controlled trial of its C-MIC device.  The study enrolled 70 ambulatory patients (32 C-MIC, 33 control) with non-ischaemic dilated cardiomyopathy with left ventricular ejection fraction (LVEF) of 25%to 35% and New York Heart Association (NYHA) class III–IV.

According to the June 2025 abstract:

“At 6 months, treatment with C-MIC versus control improved LVEF (mean difference: 5.1%; 95% confidence interval [CI] 3.1–7.1%, p < 0.001). The proportions of patients with improvement in at least one NYHA class (risk difference: 68.9%; 95% CI 50.6–87.2, p < 0.001), an increase of ≥5 points in KCCQ-OSS (risk difference: 60.0%; 95% CI 42.3–77.6, p < 0.001), and an increase of ≥30%in 6MWD (risk difference: 38.3%; 95% CI 14.4–62.2) were substantially higher in the device versus control group(p < 0.002).”

In June, Berlin Heals also reported on the 2-year follow-up of patients from the initial C-MIC pilot study who were alive at 6 month as follows:

“Of the 10 patients enrolled in the initial study, 7 were enrolled in follow-up (mean age 52.4 ± 7.6 years, NYHA Class III and mean LVEF 31.7 ± 3.7%). No device-related adverse events occurred. One non-cardiac, non-device related death was reported at 18 months. Improvement in LVEF of 11.60% [95% confidence interval (CI): 5.64–17.56, P < 0.001] from baseline to 6 months was maintained at 2 years post-C-MIC deactivation, with a sustained increase of 12.56% from baseline (95% CI: 4.67–20.45, P = 0.002). Similarly, the 6 min walk distance improved by 206.35 m at 6 months (95% CI: 161.32–251.39, P < 0.0001) and remained at 191 m above baseline at 2 years (95% CI: 131.83–250.99, P < 0.0001). Improvements in NYHA functional class and SF-36 quality-of-life scores observed at 6 months were also preserved throughout the 2 year follow-up. One patient required C-MIC reactivation.”