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

Category Archives: Therapies

AIMDs classified according to general type of therapy

Insulation Separation in Glassed Feedthrough Behind Class-I Recall of 348k Medtronic ICDs

Posted on by Posted in Cardioversion/Defibrillation, Medtronic, Tachycardia

On July 18, 2023 Medtronic recalled approximately 384,000 ICD and CRT-D devices due to increased potential for a reduced- or no-energy HV therapy.

The devices, manufactured after July 17 have a glassed feedthrough, and its insulating layers may separate.  When this happens, an unintended current pathway forms within the void created by the insulation separation, capable of conducting high levels of current during HV therapy.  The low-energy output issue is most likely to appear when the device is programmed to deliver therapy in the AX>B pathway.

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Neuralink Announces that First-in-Human Clinical Trial is Open for Recruitment

Posted on by Posted in ALS, Brain-Computer Interface, EEG Monitoring, Neuralink, Spinal Cord Injury (SCI)
Neuralink implant

Image credit: Neuralink

Neuralink announced that they have started recruiting subjects with quadriplegia due to cervical spinal cord injury or amyotrophic lateral sclerosis (ALS) for their PRIME Study (short for Precise Robotically Implanted Brain-Computer Interface), which is an IDE trial for their fully-implantable, wireless brain-computer interface (N1) and surgical robot (R1).  The study will assess the initial functionality of Neuralink’s BCI for enabling people with paralysis to control external devices with their thoughts.

According to the announcement:

During the study, the R1 Robot will be used to surgically place the N1 Implant’s ultra-fine and flexible threads in a region of the brain that controls movement intention. Once in place, the N1 Implant is cosmetically invisible and is intended to record and transmit brain signals wirelessly to an app that decodes movement intention. The initial goal of our BCI is to grant people the ability to control a computer cursor or keyboard using their thoughts alone.

The PRIME Study is being conducted under the investigational device exemption (IDE) awarded by the FDA in May 2023 and represents an important step in our mission to create a generalized brain interface to restore autonomy to those with unmet medical needs.

Those who have  may qualify.

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.

Valencia Technologies’ eCoin Approved by FDA (March 2022)

Posted on by Posted in Incontinence, Tibial Nerve Stimulation, Valencia Technologies

Valencia Technologies eCoin

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.

Saluda’s Evoke Spinal Cord Stimulation Received FDA Approval (Feb 2022)

Posted on by Posted in Neural Stimulation, Pain, Saluda Medical, Spinal Cord Stimulation
Saluda Medical Evoke IPG

Image Credit: Saluda Medical

In February 2022 FDA approved Saluds Medical’s Evoke® Spinal Cord Stimulation (SCS) System (Evoke System), which is an implanted, rechargeable spinal cord stimulation system intended to treat chronic, intractable pain in the trunk or limbs.

The Evoke® System automatically adjusts stimulation to maintain precise and consistent neural activation with breathing, coughing, positional changes and activity to keep a patient at their prescribed stimulation dose. Continue reading→

BlueWind Medical’s Revi System Tibial Neuromodulation System Approved by FDA

Posted on by Posted in Bluewind Medical, Incontinence, Neural Stimulation, Tibial Nerve Stimulation

Image Credit: Bluewind Medical

On August 17, 2023, the FDA authorized marketing for BlueWind Medical’s Revi System, a Tibial Neuromodulation System intended for use in the treatment of patients with symptoms of urgency incontinence alone or in combination with urinary urgency. The device consists of an active implantable wireless neurostimulation component intended to be placed in the vicinity of the tibial neurovascular bundle for peripheral nerve stimulation. Since the implant has no battery, the wearable unit transmits energy via magnetic coupling to the implant, which consequently generates electrical pulses stimulating the tibial nerve. These electrical pulses stimulate the nerve along the leg, reaching the sacral plexus and entering the spinal cord, relieving symptoms of urinary incontinence alone or in combination with urinary urgency.

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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.

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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.

Intelligent Implants’ SmartFuse TLIF Cage to Aid Spinal Fusion

Posted on by Posted in Bone Fracture/Fusion, Bone Growth Stimulation, Intelligent Implants

Image Credit: Intelligent Implants

Intelligent Implants is a company based in Cork, Ireland.  Their SmartFuse® platform is a wirelessly enabled orthopedics platform that has been designed to remotely stimulate, control, and monitor bone growth. The goal of the SmartFuse system is to accelerate bone growth and provide remote monitoring of the patient to support real-time clinical decision-making. The first indication for the SmartFuse system will be for use in lumbar spinal fusions.

In an interview with MedGadget, Intelligent Implants’ CEO Ben Hertzog said about the implants’ remote monitoring functions:

“In addition to stimulation, we can also use the implant to measure the electrical properties of the surgical site. The electrical properties of the mature (healed) bone are quite different than that of the immediate post-operative surgical site, so by measuring these properties, over time, we can actually detect the new bone being formed and present this data to the surgeon in a way that is indicative of healing. Our SmartFuse Cloud system enables the physician to access the data in real-time. We can also track patient compliance and system status. Overall, we can provide the surgeon with an unprecedented view into the patient’s post-operative journey, including how well they are healing. We believe this ability to accelerate bone growth AND monitor healing and patient compliance has the potential to improve outcomes dramatically.”

FDA granted SmartFuse with Breakthrough Technology designation back in May of 2021.

Impulse Dynamics Implants First Patient in AIM HIGHer Trial to Treat HF with High EF

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

On March 14, 2022, Impulse Dynamics (of which I am the CTO and Executive VP) conducted the first implant of a patient in its AIM HIGHer trial.  The goal of the blinded study is to evaluate the performance of CCM Therapy  to treat heart failure in a population with high ejection fraction (LVEF between 40% and 60%, inclusive).

According to the press release:

“Patients can have HF with severely reduced, moderately reduced, or even preserved ejection fraction (e.g., EF close to the normal range of 60% or above.) Those patients with severely reduced or moderately reduced EF have therapeutic options, including many classes of pharmaceuticals and device therapies such as CCM. However, HF patients with higher EF (e.g., above 40%) have had few therapeutic options thus far to alleviate their symptoms and treat their disease. The purpose of AIM HIGHer is to assess the potential of CCM to improve performance and reduce cardiovascular morbidity and mortality for these patients.

…

The Optimizer delivers cardiac contractility modulation therapy — a proprietary technology of Impulse Dynamics — to the heart. Impulse Dynamics has designed CCM therapy to significantly improve heart contraction, allowing more oxygen-rich blood to be pushed out through the body. This breakthrough device has demonstrated its capability of enhancing the quality of life for HF patients no longer responding adequately to medication meant to manage their symptoms.”

AIM HIGHer is the largest randomized sham-controlled therapeutic cardiac device trial to ever be conducted.

Axonix Receives FDA Approval for F15 Stimulator for Treating Bladder and Bowel Dysfunction

Posted on by Posted in Axonics, Bowel Discfunction, Incontinence, Sacral Root Stimulation

 

Image Credit: Axonix

On March 7, 2022 Axonix announced that it had received FDA Approval for its 10cc F15 Recharge-Free Sacral Neuromodulation System for the treatment of bladder and bowel dysfunction.  The device features 15+ years of functional life at typical stimulation parameters and 20+ years at lower energy settings.

 

LivaNova starts clinical trial on ImThera’s device for Obstructive Sleep Apnea

Posted on by Posted in Hypoglossal Neurostimulation, ImThera Medical, LivaNova, Obstructive Sleep Apnea
ImThera IPG

Image Credit: LivaNova

In December 2017, LivaNova acquired San Diego-based ImThera – a privately held company focused on neurostimulation for the treatment of obstructive sleep apnea (“OSA”).

The aura6000 is based on ImThera’s Targeted Hypoglossal Neurostimulation (THN) Sleep Therapy™ delivering neurostimulation to the tongue during sleep. The system is comprised of a surgically‐placed multi‐contact electrode specifically designed for the Hypoglossal nerve, and a lead that connects the electrode to a programmable, rechargeable implantable pulse generator (IPG) that is placed in the anterior chest wall. The device delivers muscle tone to key tongue muscles, preventing the tongue from collapsing into the upper airway, thus permitting normal breathing during sleep.

In March 2022, LivaNova announced that it had implanted the first patient with an InThera aura6000 in the “OSPREY” “Treating Obstructive Sleep Apnea using Targeted Hypoglossal Neurostimulation” IDE trial

Medtronic Receives FDA Approval for Interstim X™ for Bowel and Bladder Control

Posted on by Posted in Bowel Discfunction, Incontinence, Medtronic, Sacral Root Stimulation

Image Credit: Medtronic

Medtronic announced that it received approval from the U.S. Food and Drug Administration (FDA) for its InterStim X™ sacral neuromodulation system for the treatment of overactive bladder (OAB), chronic fecal incontinence (FI), and non-obstructive urinary retention.

According to the announcement, the InterStim X device features a proprietary 5th generation battery chemistry that offers more than 10 years of battery life without the need to recharge, providing patients with more freedom and less maintenance. With low energy settings, the device may last up to 15 years.

What Happens to Patients when AIMD Company Vanishes? IEEE Damning Report of Second Sight

Posted on by Posted in Blindness, Retinal Stimulation, Second Sight
Second Sight Argus II Retinal Prosthesis www.implantable-device.com David Prutchi PhD

Image Credit: Second Sight

IEEE published a damning report on Second Sight’s lack of support for patients who were implanted with their Argus and Argus II retinal prostheses.  It is unfortunate that investors and creditors are placed in font of patients who act as subjects to advance our Industry.  As the IEEE report puts it:

“After Second Sight discontinued its retinal implant in 2019 and nearly went out of business in 2020, a public offering in June 2021 raised US $57.5 million at $5 per share. The company promised to focus on its ongoing clinical trial of a brain implant, called Orion, that also provides artificial vision. But its stock price plunged to around $1.50, and in February 2022, just before this article was published, the company announced a proposed merger with an early-stage biopharmaceutical company called Nano Precision Medical (NPM). None of Second Sight’s executives will be on the leadership team of the new company, which will focus on developing NPM’s novel implant for drug delivery.”

This is not the first time that the fate and interest of patients have been been placed behind that of investors and creditors.  James Cavuoto, the Editor of Neurotech Reports proposed solutions a few years ago after a number of neurostim companies closed their doors:

‘Bankruptcy courts should put implanted patients high on the priority list of creditors. Firms or institutions that volunteer to support existing patients should get IP priority on any technology that was used. And the government should underwrite funds needed for ongoing care of orphaned patients. We owe it to patients to live up to the adage, “Do no harm.” ‘

 

 

Second Sight Acquires Drug-Delivery Company Nano Precision Medical

Posted on by Posted in Diabetes, Drug Delivery, Second Sight

From US9814867B2 – Device having titania nanotube membrane for drug delivery

Visual prosthesis maker Second Sight announced that it will issue 134M shares to acquire full ownership of Nano Precision Medical. Second Sight shareholders will own ~23% of the combined company.

Nano Precision Medical is based in the San Francisco Bay Area, and has been developing miniaturized implants using their proprietary NanoPortal™ technology for the delivery of medicines to treat chronic diseases.  Looking through cofounder Adam Mendelosohn’s patents shows passive implants that control the rate of release of therapeutic substances from a reservoir by the use of nanoporous membranes.  NPM’s lead program, NPM-119, is a near clinical stage GLP-1 receptor agonist which is being developed to treat patients with Type 2 diabetes for up to 6 months.

Second Sight had a somewhat rocky 2020 and 2021.  In 2020 they winded down operations, and then in 2021 combined with Pixium Vision.  Now they seem to be diversifying by adding completely different business fields within the implantables industry.  According to the press release:

“According to Second Sight Chairman of the Board Gregg Williams, “The merger with NPM aligns with our expanded vision to become a top device and drug implant company, allows us immediate access to NPM’s experienced executive leadership team, and provides the two companies with a myriad of opportunities to leverage potential synergies.” “