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

Category Archives: Sleep Apnea

Implantable devices to treat sleep apnea

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.”

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

FDA Approves Respicardia’s Remede EL-X System for Central Sleep Apnea

Posted on by Posted in Central Sleep Apnea, Respicardia

Image Credit: Respicardia

FDA has approved Respicardia’s  remedē® EL-X System to treat moderate to severe Central Sleep Apnea (CSA) in adult patients. The device combines enhanced functionality with a patient-friendly design, simplifying the implant procedure and providing greater device longevity for patients with Central Sleep Apnea. According to Respicardia, features of the new device include:

  • Extended longevity: 40% longer average battery life versus previous version
  • Reduced size: Approximately 25% smaller than the previous version
  • Simplified implant: Single lead, single-port system that provides both stimulation and sensing from a single lead
  • Data-driven clinical insights with DRēAM View. Enhancements include full-night, comprehensive diagnostic capabilities

Zoll Medical Acquires Sleep Apnea Treatment Company Respicardia

Posted on by Posted in Central Sleep Apnea, Neural Stimulation, Respicardia, Zoll

Image Credit: Respicardia

Zoll Medical announced on April 12, 2021 that it had acquired Respicardia and its neurostimulation technology for treating sleep apnea.  The financial terms of the deal were not disclosed.

Respicardia makes implantable neurostimulators to treat moderate to severe central sleep apnea (CSA). The system is FDA approved to treat severe CSA in adult patients with reduced cardiac function.

Zoll Medical Corporation, an Asahi Kasei company, develops and markets medical devices and software solutions for emergency care, and has been a significant Respicardia investor.

Nyxoah Receives CE Mark for Genio® System for Treating Obstructive Sleep Apnea

Posted on by Posted in Nyxoah, Obstructive 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.

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.

Continue reading→

Nyxoah Developing Implant for Obstructive Sleep Apnea and Snoring

Posted on by Posted in Neural Stimulation, Obstructive Sleep Apnea

Nyxoah patch obstructive sleep apnea David Prutchi PhD www.implantable-device.com

Nyxoah was founded in 2009 by Robert Taub and Dr. Adi Mashiach to develop neurostimulation treatments focused for Obstructive Sleep Apnea.

Nyxoah is currently engaged in clinical tests of a tiny, battery-less implantable neurostimulator that can electrically control the nerves of the tongue and so prevent airway blockage.

According to Nyxoah, the implantable device is 20mm high and 2.5mm wide (although it looks more like 20mm diameter x 2.5mm thick to me…). It’s designed to be implanted close to the nerves of the tongue muscle by a single small incision in a procedure that reportedly takes only 15 minutes.

The implant is powered and controlled by a disposable external adhesive patch.  Every evening the OSA sufferer uses a new disposable patch that has been powered by the charger. The patch, measuring only 55 x 90 mm, is attached to the skin under the chin and has enough power to wirelessly activate the implant for a full night sleep session.

Nyxoah patch obstructive sleep apnea David Prutchi PhD www.implantable-device.com

 

 

 

Sorin Launches Reply 200 Pacemakers with Sleep Apnea Monitoring

Posted on by Posted in Bradycardia, Cardiac Pacing, Sleep Apnea, Sorin

Sorin Reply 200 with apnea monitor David Prutchi PhD www.implantable-device.comSorin announced today CE mark approval and the European commercial launch of the REPLY ™ 200 family of pacemakers featuring Sleep Apnea Monitoring (SAM).  According to the press release:

Sleep apnea is highly prevalent and vastly undiagnosed in pacemaker patients. It increases the mortality risk and the risk of common cardiovascular co-morbidities such as hypertension, atrial fibrillation (AF) and heart failure (HF). Moreover, sleep apnea complicates the management of common cardiovascular co-morbidities.

The REPLY 200 SR and DR pacemakers automatically screen patients for the risk of severe sleep apnea using a highly reliable sensor that measures ventilation. The Respiratory Disturbance Index (RDI), calculated and reported by the pacemaker, has been validated against polysomnography, the gold standard method used to diagnose sleep apnea.

Continue reading→

Respicardia’s remedē Implantable Device for the Treatment of Central Sleep Apnea

Posted on by Posted in Central Sleep Apnea, Heart Failure (CHF), Respicardia, Sleep Apnea

Image Credit: Respicardia

Respicardia, Inc. (formerly Cardiac Concepts, Inc.) is a privately held medical device company incorporated in 2006. It is located in Minneapolis, Minnesota, USA.  It is developing an implantable system intended to improve the outcomes for Heart Failure patients by developing an implantable stimulation therapy to treat Central Sleep Apnea.

The remedē System is an implantable medical device that is being investigated in a clinical research study for the treatment of Central Sleep Apnea in patients with Heart Failure.  It consists of three implantable components:

  • remedē Pulse Generator comprised of electronic circuitry components and a battery, which are hermetically sealed in a titanium case
  • remedē Stimulation Lead that is implanted in a vein close to one of the phrenic nerves
  • a sensing lead to detect respiration Continue reading→

ImThera Medical’s Aura6000 Implantable System for the Treatment of Sleep Apnea

Posted on by Posted in ImThera Medical, Obstructive Sleep Apnea, Rechargeable Batteries, Sleep Apnea
ImThera Aura 6000 implantable device for the treatment of obstructive sleep apnea

Image Credit: Imthera

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 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. Continue reading→

Apnex Medical’s Implantable Device for Treatment of Sleep Apnea

Posted on by Posted in Apnex Medical, Obstructive Sleep Apnea, Sleep Apnea

Image Credit: Apnex Medical

MedicalApnex Medical, Inc. is located in St. Paul, MN. It was founded in 2006 and has developed the Hypoglossal Nerve Stimulation System (HGNS® System) for the treatment of obstructive sleep apnea (OSA). The HGNS System has been evaluated in feasibility studies and is now being assessed in an Investigational Device Exemption (IDE) Study (Apnex®Clinical Study).

The Apnex HGNS System is an implantable therapy that is intended to work by activating the muscles in the upper airway to ensure that the airway remains open during sleep. During sleep, the system detects the patient’s breathing and delivers mild stimulation to the hypoglossal nerve, the nerve that controls the muscles of the tongue, to keep the airway open. The stimulation is timed to a patient’s own breathing pattern. The HGNS System is programmed to work only when the patient is asleep, or it can be turned on and off as needed through a handheld controller. Continue reading→

Inspire Medical’s IPG for the Treatment of Sleep Apnea

Posted on by Posted in Inspire Medical, Sleep Apnea

Image credit: Inspire Medical

Inspire Medical Systems, based in Minneapolis, Minnesota, develops implantable neurostimulation systems to treat Obstructive Sleep Apnea (OSA).  Inspire Medical Systems was formed when the Inspire intellectual property and technology was licensed and spun out from Medtronic in 2007.

Inspire therapy is designed to deliver physiologically-timed, mild stimulation to the hypoglossal nerve on each breathing cycle to prevent airway obstruction during sleep.

Continue reading→