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

Author Archives: David Prutchi

Paxos Medical developing neurostimulator for on-demand bladder voiding

Posted on by Posted in BladderVoiding, Paxos Medical
Paxos Medical is developing an implantable neuromodulation system that allows on demand bladder voiding without the use of 4-6 daily self-catheterizations for underactive bladder patients.

Image Credit: Paxos Medical, captured from Paxos Medical’s Lightning Pitch

Paxos Medical was founded in 2022 by Matthew Fraser, PhD and Jeff Erb in Marple Trail, Minnesota.  The company is developing an implantable neuromodulation system that allows on-demand bladder voiding, and is intended to replace the need for 4-6 daily self-catheterizations for underactive bladder patients.

Detailed information is still scarce, but the PCT publication of their patent application indicates that the idea is to stimulate the nerves of the proximal urethra to initiate and sustain urination.  Paxos has mentioned that 60 seconds of stimulation to pro-voiding nerve bundles can drive a void to completion.

 

 

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.

Affluent Medical’s Artus Artificial Sphincter for Urinary Incontinence

Posted on by Posted in Affluent Medical, Artificial Sphincter, Incontinence, MPS Micro Precision Systems, Myopowers
Affluent Medical's Artus artificial sphincter for urinary incontinence

Image credit: Affluent Medical

Walking down MD&M Minneapolis’ aisles, I saw an implantable device that I hadn’t seen before. It is an artificial mechanical sphincter being developed by Affluent Medical based in Aix-en-Provence, France.  The device is aimed at treating stress urinary incontinence, which is a disabling condition that results in uncontrolled urinary leakage during effort such as coughing or sport.

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SOMACIS Group acquires Dyconex from Biotronik’s MST

Posted on by Posted in Biotronik, DYCONEX

Dyconex logo

On September 13, 2024 it was announced that Dyconex officially joined the SOMACIS Group headquartered in Italy.

Dyconex is a Swiss company specializing in high-reliability PCBs for medical implantable devices.  It formerly belonged to Biotronik’s MST group, putting it out of reach from many implantable companies that Biotronik saw as potential competitors.  However, their high-rel PCB manufacturing is open to anyone in the Industry.  Details about the acquisition haven’t been made public.

 

ShiraTronics raises $66M for pivotal trial treating migraine

Posted on by Posted in Cluster Headaches, Migraine, Occipital Nerve Stimulation, ShiraTronics

 

ShiraTronics Implantable device for the treatment of migraine

Image Credit: ShiraTronics

Broolin Park (MN)-based ShiraTronics  developed a system that is intended to provide electrical stimulation to nerves associated with migraine pain. The therapy includes a temporary Trial System and a permanent Implant System. The Trial System components include percutaneous leads temporarily placed in the supraorbital and occipital regions. The Implant System components include rechargeable IPGs with integrated leads. The IPGs are implanted in subcutaneous pockets posteriorly on the head with leads tunneled to the supraorbital and occipital regions. Both systems are controlled by a programmer with a therapy application.

This summer ShiraTronics presented 12-week results on 10 patients enrolled its pilot clinical trial in Australia of its implantable system intended for the prophylactic treatment of refractory chronic migraine.

ShiraTronics announced yesterday the closing of a $66 million Series B financing.  According to the press release:

“This latest round of funding will support ShiraTronics’ recently launched U.S. Food and Drug Administration (FDA)-approved pivotal trial, the RELIEV-CM2 Clinical Study, a multi-center, blinded, randomized, sham-controlled clinical trial. The trial is designed to evaluate the safety and effectiveness of the company’s Migraine Therapy System in patients who have failed current medical therapies and have treatment-resistant chronic migraine. The financing also will support the company as it seeks premarket approval from the FDA and fund the initial commercial launch of its innovative therapy for chronic migraine patients.”

Axonics Prevails in Patent Infringement Lawsuit with Medtronic

Posted on by Posted in AIMD Business, Axonics, Bowel Discfunction, Incontinence, Medtronic, Sacral Root Stimulation, Wireless Power Transmission
Axonix rechargeable stimulator

Image Credit: Axonix

Axonix announced that a jury in the U.S. District Court for the Central District of California returned a unanimous verdict in the patent infringement lawsuit brought by Medtronic against Axonics in Axonix favor.

The jury ruled unanimously for Axonics, on claims related to three separate patents.  One relates to transcutaneous recharging, and the other two two  to the implantation of electrodes for stimulating the sacral nerve to help support urinary and bowel control.

The case has been one of several intellectual property disputes between Medtronic and Axonics, which is expected to become a Boston Scientific subsidiary in a $3.7 billion deal.

 

Comphya’s CaverSTIM System to treat Erectile Disfunction

Posted on by Posted in Cavernous Nerve Stimulation, Cirtec, Comphya, Erectile Disorder
CaverSTIM IPG for ED by Comphya

Image Credit: Comphya

Comphya is a company based in Lausanne, Switzerland developing a system for the treatment of erectile disorder due to spinal cord injury or prostatectomy.

The CaverSTIM System is based on the Algovita Platform which was acquired by Cirtec when Nuvectra declared bankruptcy.

The IPG provides self-controlled stimulation (via a wireless remote control) to the cavernous nerve to restore natural erectile function. According to Comphya, their innovation has a key element which can overcome a major barrier for the therapy, the complex anatomy of the neural path for erection, and it can guarantee the identification of the site for stimulation within the pelvic cavity.   Comphya has tested this in an acute clinical trial (J Sex Med. 2018 Nov;15(11):1558-1569).

Their first implant took place in August 2023 at the Royal Melbourne Hospital.  In October of 2023, the device was first implanted in a spinal cord injury patient at Hospital Mario Covas in Brazil. More recently, in August 2024 Comphya announced that it had received approval from the Brazilian National Research Ethics Committees (CEP and CONEP) and the federal regulatory authority ANVISA to initiate a pilot clinical trial in patients undergoing prostatectomy.

CaverSTIM system by Comphya

Image Credit: Comphya

FDA approves Senseonics’ Eversense one-year implantable CGM

Posted on by Posted in Diabetes, Glucose Monitoring, Senseonics

Senseonics implantable glucose sensor www.implantable-device.com David Prutchi PhD

Senseonics announced that it had received FDA’s approval for its next-generation Eversense® 365 Continuous Glucose Monitoring (CGM) system for people with Type 1 and Type 2 diabetes aged 18 years and older. Eversense 365 is the world’s first One Year CGM system.

According to the announcement, “Eversense 365 has been cleared as an integrated CGM (iCGM) system, indicating that it can integrate with compatible medical devices, including insulin pumps as part of an automated insulin delivery (AID) system.”

 

Neuralink receives FDA’s Breakthrough Device designation for its Blindsight Device

Posted on by Posted in Blindness, Brain Stimulation, Neuralink
Neuralink implant

Image credit: Neuralink

Yesterday Neuralink announced that its Blindsight Device had been granted “Breakthrough Device” designation by the FDA.  According to Elan Musk, the device “will enable even those who have lost both eyes and their optic nerve to see.”

Details about the Blindsight Device or commencement of a clinical trial are scarce at this time.

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.

 

 

Abbott starts clinical trial of DBS to treat depression

Posted on by Posted in Abbott, Brain Stimulation, Depression
Abbott St Jude Medical Infinity DBS IPG

Image Credit: Abbott

Back in 2022, the FDA granted Abbott Breakthrough Device designation for deep brain stimulation (DBS) for treatment-resistant depression (TRD), a form of major depressive disorder.  Now Abbott announced it has initiated a pivotal clinical trial, called the TRANSCEND study, to evaluate the use of the company’s DBS system to manage TRD.

Previous open-label studies exploring the use of DBS for TRD have shown at least a 50% sustained improvement in symptoms of depression for three out of four people over a period of two to eight years.

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Veris Health developing smart chemotherapy port

Posted on by Posted in Cancer, Chemotherapy Monitoring, Veris Health
Veris Health's smart chemotherapy port

Image credit: Veris Health

Veris Health, a wholly-owned subsidiary of  New York’s PAVmed Inc., is a digital health company that has developed a digital cancer care platform with physiologic data collection, symptom reporting, and telehealth functions.  The Veris CPP is meant to improve personalized cancer care through remote patient monitoring.

Besides traditional Bluetooth-enabled physiologic sensors, Veris has been developing an implantable physiological monitor, designed to be implanted alongside a chemotherapy port, which will interface with the Veris cancer care remote patient monitoring platform.

This is the first time I see this interesting concept, so I wanted to bring it to the attention of my readers although I haven’t found details on the implant besides a presentation at LSI USA ‘23 Emerging Medtech Summit by its Chairman and CEO, Dr. Lishan Aklog.

Veris RPM implantable smart port

Image credit: Veris Health

FDA recalls 32 Inspire model 3028 IPGs

Posted on by Posted in Inspire Medical, Neural Stimulation, Obstructive Sleep Apnea, Sleep Apnea

Image Credit: Inspire Medical

FDA has recalled 32 Inspire IV model 3028 IPGs due to a manufacturing defect which can cause system malfunctions after implantation, leading to electrical leakage in the sensing circuit. As a result, patients may need revision surgery to replace the neurostimulator IPG and restore therapy for obstructive sleep apnea.

According to the recall announcement:

“The use of affected product may cause serious adverse health consequences, including stimulation below normal therapeutic levels and/or early depletion of the battery (resulting in – loss of therapy), inappropriate or inconsistent stimulation effect, painful stimulation or perceived shocking sensation and death.

There have been no reported injuries. There have been no reports of death.”