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.
Category Archives: Treated Conditions
Implantable Devices to treat specific conditions
ShiraTronics raises $66M for pivotal trial treating migraine
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
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
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.
FDA approves Senseonics’ Eversense one-year implantable CGM
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
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
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
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
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.
Veris Health developing smart chemotherapy port
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.
Edwards acquires Endotronix
Edwards announced the acquisition of Endotronix, the maker of the Cordella implantable pulmonary artery pressure sensor that allows for early, targeted therapeutic intervention and was recently approved by FDA.
FDA recalls 32 Inspire model 3028 IPGs
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.”
FDA approves Endotronix’s Cordella PA Sensor
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.”
Picostim DBS device implanted in child with Lennox-Gastaut syndrome
UK news outlets reported that a Picostim deep-breain stimulator made by UK company Bioinduction (which was recently acquired by Amber Therapeutics) was recently implanted in a boy with Lennox-Gastaut syndrome, which is a a severe, treatment-resistant form of epilepsy that he developed at the age of three.
The implant was performed at the UCL Great Ormond Street Institute of Child Health & Great Ormond Street Hospital under the “CADET” project (Children’s Adaptive Deep brain stimulation for Epilepsy Trial). According to the project’s website, the Picostim system is especially suitable for DBS therapy in this application:
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“The advanced capabilities of Picostim DyNeuMo-1 allow for personalised and adaptive stimulation regimes according to seizure patterns and circadian (wake/sleep) rhythms at an individual patient level, which are key components of LGS symptoms. These capabilities are here proposed to maximize the potential of DBS to limit seizure spread, and reduce seizure frequency and severity.
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These capabilities are made possible by the ability to non-invasively and repeatedly recharge the device. Patients or parents are able to use a handheld or headset-mounted charger that safely recharges the battery through the skin.
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The device allows for the recording of electrical activity in the implanted brain, potentially allowing stimulation parameters that are tailored to LGS and to the individual child.
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Lastly, the whole device is mounted to the skull, removing the need for (painful) tunneling of extension leads to a battery implanted in the chest wall and potentially reducing the risk of infection.”
The CADET pilot (Children’s adaptive deep brain stimulation for epilepsy trial) will now recruit three additional patients with Lennox-Gastaut syndrome, with a view to 22 patients being recruited to take part in a full trial.
Science acquires assets and clinical studies from Pixium Vision SA
Science – the company recently started by Neuralink’s co-founder Max Hodak announced that it is acquiring Pixium Vision‘s assets.
Pixium Vision’s Prima system to treat vision loss is implanted in 47 subjects across Europe and the United States. However, it ran out of cash, and was in danger of abandoning the study. Science’s acquisition of Pixium’s technology includes the three ongoing clinical trials in late-stage macular degeneration.
On its side, Science is developing the “Science Eye,” which is a combination device comprising Optogenetic gene therapy and an implantable, high-resolution display. The first part of the procedure consists of a protein nanoparticle used to deliver a gene to some of the retinal ganglion cells, making them light-sensitive at a specific wavelength. Then, a very small, flexible, high-resolution display film is implanted over the retina to allow fine control of the newly light-sensitive ganglion cells.
In the announcement, Max Hodak stated about the acquisition of Pixium’s competing technology:
“What does this mean for our optogenetic gene therapy and the Science Eye? It’s too early to know which approach, electrical or optogenetic, will work best in the retina long term as these technologies mature. But whichever is used 20 years from now, there is a huge amount of good all of these early devices can do today. They represent very different approaches that make different tradeoffs and at least initially will probably target different patient subpopulations. We would love to be able to offer a range of products to match each individual patient’s needs with the best of what’s available over time.”