INSPIRE MEDICAL SYSTEMS INC

FDA Registration(s)#

Registered Device Listings#

Product Codes Associated With Registrations#

PMA#

• Inspire II Upper Airway Stimulator

  2022-12-16

  INSPIRE MEDICAL SYSTEMS9700 63rd Avenue Northsuite 200maple Grove, MN 55369 PMA NumberP130008 Supplement NumberS093 Date Received11/18/2022 Decision Date12/16/2022 Product Code MNQ  Advisory Committee Anesthesiology Clinical TrialsNCT04457154 Supplement Typ...

• Inspire Implantable Pulse Generator (IPG)

  2022-08-19

  INSPIRE MEDICAL SYSTEMS9700 63rd Avenue Northsuite 200maple Grove, MN 55369 PMA NumberP130008 Supplement NumberS088 Date Received07/29/2022 Decision Date08/19/2022 Product Code MNQ  Advisory Committee Anesthesiology Supplement Type30-day Notice Supplement R...

• Inspire Silicone Stimulation Lead, Inspire Silicone Sensing Lead

  2022-06-16

  INSPIRE MEDICAL SYSTEMS9700 63rd Avenue Northsuite 200maple Grove, MN 55369 PMA NumberP130008 Supplement NumberS084 Date Received05/20/2022 Decision Date06/16/2022 Product Code MNQ  Advisory Committee Anesthesiology Supplement Type30-day Notice Supplement R...

• Inspire Respiratory Sensing Lead and Inspire Stimulation Lead

  2022-04-07

  INSPIRE MEDICAL SYSTEMS9700 63rd Avenue Northsuite 200maple Grove, MN 55369 PMA NumberP130008 Supplement NumberS083 Date Received03/15/2022 Decision Date04/07/2022 Product Code MNQ  Advisory Committee Anesthesiology Supplement Type30-day Notice Supplement R...

• Inspire Patient Remote

  2022-04-01

  INSPIRE MEDICAL SYSTEMS9700 63rd Avenue Northsuite 200maple Grove, MN 55369 PMA NumberP130008 Supplement NumberS082 Date Received03/02/2022 Decision Date04/01/2022 Product Code MNQ  Advisory Committee Anesthesiology Supplement Type30-day Notice Supplement R...

• Inspire Model 2580 Sleep Remote

  2022-03-16

  INSPIRE MEDICAL SYSTEMS9700 63rd Avenue Northsuite 200maple Grove, MN 55369 PMA NumberP130008 Supplement NumberS080 Date Received02/17/2022 Decision Date03/16/2022 Product Code MNQ  Advisory Committee Anesthesiology Supplement Type30-day Notice Supplement R...

• Inspire Model 4340 Respiratory Sensing Lead

  2022-03-14

  INSPIRE MEDICAL SYSTEMS9700 63rd Avenue Northsuite 200maple Grove, MN 55369 PMA NumberP130008 Supplement NumberS081 Date Received02/17/2022 Decision Date03/14/2022 Product Code MNQ  Advisory Committee Anesthesiology Supplement Type30-day Notice Supplement R...

• Inspire Model 2740 Programmer

  2022-03-10

  INSPIRE MEDICAL SYSTEMS9700 63rd Avenue Northsuite 200maple Grove, MN 55369 PMA NumberP130008 Supplement NumberS079 Date Received02/11/2022 Decision Date03/10/2022 Product Code MNQ  Advisory Committee Anesthesiology Supplement Type30-day Notice Supplement R...

• Inspire Implantable Pulse Generator (IPG) Model 2580 Patient Remote

  2022-02-11

  INSPIRE MEDICAL SYSTEMS

• Inspire Implantable Pulse Generator (IPG)

  2022-02-02

  INSPIRE MEDICAL SYSTEMS

• Inspire Model 4340 Respiratory Sensing Lead

  2021-11-03

  INSPIRE MEDICAL SYSTEMS

• Inspire II Upper Airway Stimulator

  2021-09-10

  INSPIRE MEDICAL SYSTEMS

• Inspire Implantable Pulse Generator (IPG)

  2021-08-12

  INSPIRE MEDICAL SYSTEMS

• Inspire Upper Airway Stimulation (UAS)

  2021-06-24

  INSPIRE MEDICAL SYSTEMS

• Inspire Upper Airway Stimulation (UAS)

  2021-06-11

  INSPIRE MEDICAL SYSTEMS

• Inspire Upper Airway Stimulation System

  2021-04-09

  INSPIRE MEDICAL SYSTEMS

• Inspire II Upper Airway Stimulator

  2021-03-12

  INSPIRE MEDICAL SYSTEMS

• Inspire IV IPG

  2020-10-14

  INSPIRE MEDICAL SYSTEMS

• Inspire IV IPG

  2020-09-29

  INSPIRE MEDICAL SYSTEMS

• Inspire Upper Airway Stimulation

  2020-09-24

  INSPIRE MEDICAL SYSTEMS

• Inspire Implantable Pulse Generator

  2020-09-16

  INSPIRE MEDICAL SYSTEMS

• Inspire Respiratory Sensing Lead

  2020-07-20

  INSPIRE MEDICAL SYSTEMS

• Inspire IV IPG

  2020-06-18

  INSPIRE MEDICAL SYSTEMS

• Inspire Upper Airway Stimulation

  2020-06-12

  INSPIRE MEDICAL SYSTEMS

• Inspire II Upper Airway Stimulator

  2020-03-02

  INSPIRE MEDICAL SYSTEMS

• Inspire Upper Airway Stimulation System

  2020-01-16

  INSPIRE MEDICAL SYSTEMS

• Implantable Pulse Generator, Sensing Lead, and Stimulation Lead

  2020-01-10

  INSPIRE MEDICAL SYSTEMS

• Inspire Upper Airway Stimulation System

  2019-09-11

  INSPIRE MEDICAL SYSTEMS

• Inspire Upper Airway Stimulation System

  2019-07-25

  INSPIRE MEDICAL SYSTEMS

• Inspire Upper Airway Stimulation System

  2019-07-22

  INSPIRE MEDICAL SYSTEMS

• Inspire II Upper Airway Stimulator

  2019-06-21

  INSPIRE MEDICAL SYSTEMS

• Inspire Upper Airway Stimulator

  2019-03-06

  INSPIRE MEDICAL SYSTEMS

• Model 4340 Respiratory Sensing Lead

  2019-01-28

  INSPIRE MEDICAL SYSTEMS

• Model 3028 Implantable Pulse Generator

  2019-01-24

  INSPIRE MEDICAL SYSTEMS

• Stimulator, Hypoglossal Nerve, Implanted, Apnea

  2019-01-09

  INSPIRE MEDICAL SYSTEMS

• Inspire Model 4323 Sensing Lead

  2018-11-19

  INSPIRE MEDICAL SYSTEMS

• Inspire Model 2740 Physician Programmer

  2018-11-01

  INSPIRE MEDICAL SYSTEMS

• INSPIRE II UPPER AIRWAY STIMULATOR

  2018-09-14

  INSPIRE MEDICAL SYSTEMS

• Inspire Upper Airway Stimulator

  2018-05-15

  INSPIRE MEDICAL SYSTEMS

• Inspire Upper Airway Stimulation Therapy

  2018-05-11

  INSPIRE MEDICAL SYSTEMS

70 records. Showing 1-40. Next

GUDID#

• Inspire - A nonpowered neurosurgical instrument is a hand instrument or an accessory to a hand instrument used during neurosurgical procedures to cut, hold, or manipulate tissue. It includes specialized chisels, osteotomes, curettes, dissectors, elevators, forceps, gouges, hooks, surgical knives, rasps, scissors, separators, spatulas, spoons, blades, blade holders, blade breakers, probes, etc.

  Inspire Medical Systems, Inc.

  2025-10-29

• Inspire - The Inspire® Stimulation Lead (Model 4063) is designed to deliver stimulation to the hypoglossal nerve for the treatment of obstructive sleep apnea. The lead features a flexible, self-sizing cuff. Electrodes in the inner surface of the cuff deliver stimulation to the nerve. The lead incorporates a standard connector for coupling to the Inspire implantable pulse generator (IPG).

  Inspire Medical Systems, Inc.

  2022-08-16

• Inspire - The Inspire® Stimulation Lead (Model 4063) is designed to deliver stimulation to the hypoglossal nerve for the treatment of obstructive sleep apnea. The lead features a flexible, self-sizing cuff. Electrodes in the inner surface of the cuff deliver stimulation to the nerve. The lead incorporates a standard connector for coupling to the Inspire implantable pulse generator (IPG).

  Inspire Medical Systems, Inc.

  2025-02-24

• Inspire - The Inspire® Stimulation Lead (Model 4063) is designed to deliver stimulation to the hypoglossal nerve for the treatment of obstructive sleep apnea. The lead features a flexible, self-sizing cuff. Electrodes in the inner surface of the cuff deliver stimulation to the nerve. The lead incorporates a standard connector for coupling to the Inspire implantable pulse generator (IPG).

  Inspire Medical Systems, Inc.

  2025-07-29

• Inspire - The Inspire® Respiratory Sensing Lead (Model 4340) is designed to detect respiratory effort. The lead features a pressure sensitive membrane that converts the mechanical energy of respiration into an electrical signal. The lead incorporates a standard connector for coupling to the Inspire implantable pulse generator (IPG) for treatment of obstructive sleep apnea.

  Inspire Medical Systems, Inc.

  2025-02-24

• Inspire - The Model 2740S&C Programmer Cable is responsible for transferring device data from the generator through the skin via short-range inductive radiofrequency (RF) telemetry. The programmer cable is powered by a wall outlet connection and wirelessly transfers data (via Bluetooth Low Energy) to the tablet.

  Inspire Medical Systems, Inc.

  2025-01-21

• Inspire - The Model 3150 IPG is the next generation Implantable Pulse Generator (IPG). It contains electronics and a battery that are sealed inside a titanium case. The Model 3150 is smaller in size than the previous model (3028) and eliminates the need of an Inspire respiratory sensing lead by having a built-in sensing accelerometer in the Model 3150 generator itself. The IPG is implanted subcutaneously, below the clavicle in the upper chest, and connects to the Inspire stimulation lead. The Model 3150 introduces improved communication speed between the IPG and the external products along with enhanced security. The Inspire system stimulates the hypoglossal nerve, synchronous with the patient’s respiration cycle using closed loop sensing technology. The timed stimulation elicits a neuromuscular response from the base of the tongue thereby preventing upper airway collapse that causes airflow obstruction in many OSA patients. The Model 3150 IPG will also allow patients to safely undergo magnetic resonance imaging (MRI) under specified conditions.

  Inspire Medical Systems, Inc.

  2024-12-06

• Inspire - The sleep remote is an external device that is about the size of a cell phone and is used by the patient to activate the Inspire system before they go to sleep. The patient places the remote over the implanted IPG site, and uses push buttons on top of the programmer to: a.) turn the therapy ON or OFF, b.) temporarily suspend therapy, or c.) make adjustments to the stimulation strength (within limits set by the physician). The patient’s sleep remote also allows patients to check the status of the IPG battery. There are both visual and audio indicators that provide information on the IPG status (therapy ON/OFF, therapy paused, stimulation level and battery status). The Inspire sleep remote will only communicate with the Inspire IPG.

  Inspire Medical Systems, Inc.

  2024-10-10

• Inspire - The sleep remote is an external device that is about the size of a cell phone and is used by the patient to activate the Inspire system before they go to sleep. The patient places the remote over the implanted IPG site, and uses push buttons on top of the programmer to: a.) turn the therapy ON or OFF, b.) temporarily suspend therapy, or c.) make adjustments to the stimulation strength (within limits set by the physician). The patient’s sleep remote also allows patients to check the status of the IPG battery. There are both visual and audio indicators that provide information on the IPG status (therapy ON/OFF, therapy paused, stimulation level and battery status). The Inspire sleep remote will only communicate with the Inspire IPG.

  Inspire Medical Systems, Inc.

  2024-10-10

• Inspire - The Model 2740C Programmer Cable is responsible for transferring device data from the generator through the skin via short-range inductive radiofrequency (RF) telemetry. The programmer cable is powered by a wall outlet connection and wirelessly transfers data (via Bluetooth Low Energy) to the tablet.

  Inspire Medical Systems, Inc.

  2024-09-11

• Inspire - The Model 3028 IPG contains electronics and a battery that are sealed inside a titanium case. The IPG is implanted subcutaneously, below the clavicle in the upper chest, and connect to the stimulation lead and sensing lead. The Model 3028 does not contain any software or firmware. All functions including the telemetry and algorithm have been designed into the hardware of the IPG. The algorithm synchronizes stimulation of the hypoglossal nerve with respiration signals. The IPG processes the same dynamic range of pressure signals (2-48 cmH2O) in order to account for pressure reading variability. Based on typical settings from the STAR pivotal trial, the longevity of the Model 3028’s battery will average 10 years although the device is smaller than the currently approved version (Model 3024). In addition the Model 3028 IPG will allow patients to safely undergo magnetic resonance imaging (MRI) under specified conditions.

  Inspire Medical Systems, Inc.

  2024-07-08

• Inspire - The Model 2740S SleepSync Programmer Application is a standalone software that is downloaded and installed on a user-owned computer and paired by the user (clinician) with the Model 2740C Programmer Cable to non-invasively interrogate and program the Implantable Pulse Generator (IPG) of the Inspire Upper Airway Stimulation (UAS) System. The SleepSync Programmer Application provides the graphic user interface (GUI) for the SleepSync Programmer System (Model 2740S and Model 2740C) while the Programmer Cable provides the communications interface between the SleepSync Programmer Application and the IPG. The SleepSync Programmer Application has the capability to monitor respiratory waveforms, program stimulation modes, adjust stimulation parameter values, and store waveforms and settings.

  Inspire Medical Systems, Inc.

  2024-05-15

• Inspire - The Model 2740 physician programmer is designed for use by a physician to non invasively interrogateand program the IPG. It is the only component in the Inspire system that contains software. Thisprogrammer consists of a tablet computer and a telemetry cable. The telemetry head communicateswith the IPG through the skin via short range radio frequency (RF) telemetry, telemetry communicationallows the physician to noninvasively interrogate and program the IPG. The telemetry head is poweredby a wall outlet connection and wirelessly communicates (via wireless Bluetooth link) with the physicianprogrammer tablet. The physician programmer has the capability to monitor respiratory waveforms,program stimulation modes, adjust stimulation parameter values, and store waveforms and settings.

  Inspire Medical Systems, Inc.

  2024-01-03

• Inspire - The Model 2740 physician programmer is designed for use by a physician to non invasively interrogateand program the IPG. It is the only component in the Inspire system that contains software. Thisprogrammer consists of a tablet computer and a telemetry cable. The telemetry head communicateswith the IPG through the skin via short range radio frequency (RF) telemetry, telemetry communicationallows the physician to noninvasively interrogate and program the IPG. The telemetry head is poweredby a wall outlet connection and wirelessly communicates (via wireless Bluetooth link) with the physicianprogrammer tablet. The physician programmer has the capability to monitor respiratory waveforms,program stimulation modes, adjust stimulation parameter values, and store waveforms and settings.

  Inspire Medical Systems, Inc.

  2023-04-26

• Inspire - The Model 3028 IPG contains electronics and a battery that are sealed inside a titanium case. The IPG is implanted subcutaneously, below the clavicle in the upper chest, and connect to the stimulation lead and sensing lead. The Model 3028 does not contain any software or firmware. All functions including the telemetry and algorithm have been designed into the hardware of the IPG. The algorithm synchronizes stimulation of the hypoglossal nerve with respiration signals. The IPG processes the same dynamic range of pressure signals (2-48 cmH2O) in order to account for pressure reading variability. Based on typical settings from the STAR pivotal trial, the longevity of the Model 3028’s battery will average 10 years although the device is smaller than the currently approved version (Model 3024). In addition the Model 3028 IPG will allow patients to safely undergo magnetic resonance imaging (MRI) under specified conditions.

  Inspire Medical Systems, Inc.

  2023-04-06

• Inspire - The sleep remote is an external device that is about the size of a cell phone and is used by the patient to activate the Inspire system before they go to sleep. The patient places the remote over the implanted IPG site, and uses push buttons on top of the programmer to: a.) turn the therapy ON or OFF, b.) temporarily suspend therapy, or c.) make adjustments to the stimulation strength (within limits set by the physician). The patient’s sleep remote also allows patients to check the status of the IPG battery. There are both visual and audio indicators that provide information on the IPG status (therapy ON/OFF, therapy paused, stimulation level and battery status). The Inspire sleep remote will only communicate with the Inspire IPG.

  Inspire Medical Systems, Inc.

  2023-01-13

• Inspire - The sleep remote is an external device that is about the size of a cell phone and is used by the patient to activate the Inspire system before they go to sleep. The patient places the remote over the implanted IPG site, and uses push buttons on top of the programmer to: a.) turn the therapy ON or OFF, b.) temporarily suspend therapy, or c.) make adjustments to the stimulation strength (within limits set by the physician). The patient’s sleep remote also allows patients to check the status of the IPG battery. There are both visual and audio indicators that provide information on the IPG status (therapy ON/OFF, therapy paused, stimulation level and battery status). The Inspire sleep remote will only communicate with the Inspire IPG.

  Inspire Medical Systems, Inc.

  2022-09-29

• Inspire - The Inspire® Respiratory Sensing Lead (Model 4340) is designed to detect respiratory effort. The lead features a pressure sensitive membrane that converts the mechanical energy of respiration into an electrical signal. The lead incorporates a standard connector for coupling to the Inspire implantable pulse generator (IPG) for treatment of obstructive sleep apnea.

  Inspire Medical Systems, Inc.

  2022-08-16

• Inspire - The sleep remote is an external device that is about the size of a cell phone and is used by the patient to activate the Inspire system before they go to sleep. The patient places the remote over the implanted IPG site, and uses push buttons on top of the programmer to: a.) turn the therapy ON or OFF, b.) temporarily suspend therapy, or c.) make adjustments to the stimulation strength (within limits set by the physician). The patient’s sleep remote also allows patients to check the status of the IPG battery. There are both visual and audio indicators that provide information on the IPG status (therapy ON/OFF, therapy paused, stimulation level and battery status). The Inspire sleep remote will only communicate with the Inspire IPG.

  Inspire Medical Systems, Inc.

  2022-05-09

• Inspire - The Model 2740 physician programmer is designed for use by a physician to non invasively interrogateand program the IPG. It is the only component in the Inspire system that contains software. Thisprogrammer consists of a tablet computer and a telemetry cable. The telemetry head communicateswith the IPG through the skin via short range radio frequency (RF) telemetry, telemetry communicationallows the physician to noninvasively interrogate and program the IPG. The telemetry head is poweredby a wall outlet connection and wirelessly communicates (via wireless Bluetooth link) with the physicianprogrammer tablet. The physician programmer has the capability to monitor respiratory waveforms,program stimulation modes, adjust stimulation parameter values, and store waveforms and settings.

  Inspire Medical Systems, Inc.

  2022-01-26

• Inspire - The sensing lead incorporates a differential pressure sensor that detects respiratory cycles. The connector end of the lead is connected to the IPG. The sensor is implanted in between the intercostal muscle layers. The device senses relative pressure variations that correspond to the respiration cycle. The pressure waveform is monitored by the IPG and triggers stimulation therapy synchronous with inspiration

  Inspire Medical Systems, Inc.

  2021-03-19

• Inspire - The stimulation lead incorporates a cuff segment that includes three electrodes in a guarded-bipolar configuration, which means the center electrode is connected to one pole of the stimulation (e.g., negative pole), and is flanked on each side by two electrodes connected to the opposite pole of stimulation (e.g., positive pole). It is packaged with a tunneling rod to facilitate the implant procedure. The cuff is surgically positioned around a patient’s hypoglossal nerve, and the connector end of the lead is connected to the IPG. The cuff electrodes apply electrical current that stimulates the nerve causing the tongue to move forward. The tongue movement (via genioglossus and other tongue protrusor muscle contraction) serves to maintain an open airway. The figure below provides an illustration of the Model 4063 stimulation lead.

  Inspire Medical Systems, Inc.

  2021-03-19

• Inspire - The Model 2740 physician programmer is designed for use by a physician to non invasively interrogateand program the IPG. It is the only component in the Inspire system that contains software. Thisprogrammer consists of a tablet computer and a telemetry cable. The telemetry head communicateswith the IPG through the skin via short range radio frequency (RF) telemetry, telemetry communicationallows the physician to noninvasively interrogate and program the IPG. The telemetry head is poweredby a wall outlet connection and wirelessly communicates (via wireless Bluetooth link) with the physicianprogrammer tablet. The physician programmer has the capability to monitor respiratory waveforms,program stimulation modes, adjust stimulation parameter values, and store waveforms and settings.

  Inspire Medical Systems, Inc.

  2021-03-19

• Inspire - The Model 2740 physician programmer is designed for use by a physician to non invasively interrogateand program the IPG. It is the only component in the Inspire system that contains software. Thisprogrammer consists of a tablet computer and a telemetry cable. The telemetry head communicateswith the IPG through the skin via short range radio frequency (RF) telemetry, telemetry communicationallows the physician to noninvasively interrogate and program the IPG. The telemetry head is poweredby a wall outlet connection and wirelessly communicates (via wireless Bluetooth link) with the physicianprogrammer tablet. The physician programmer has the capability to monitor respiratory waveforms,program stimulation modes, adjust stimulation parameter values, and store waveforms and settings.

  Inspire Medical Systems, Inc.

  2021-03-19

• Inspire - The Model 3028 IPG contains electronics and a battery that are sealed inside a titanium case. The IPG is implanted subcutaneously, below the clavicle in the upper chest, and connect to the stimulation lead and sensing lead. The Model 3028 does not contain any software or firmware. All functions including the telemetry and algorithm have been designed into the hardware of the IPG. The algorithm synchronizes stimulation of the hypoglossal nerve with respiration signals. The IPG processes the same dynamic range of pressure signals (2-48 cmH2O) in order to account for pressure reading variability. Based on typical settings from the STAR pivotal trial, the longevity of the Model 3028’s battery will average 10 years although the device is smaller than the currently approved version (Model 3024). In addition the Model 3028 IPG will allow patients to safely undergo magnetic resonance imaging (MRI) under specified conditions.

  Inspire Medical Systems, Inc.

  2021-01-13

• Inspire - The Model 3028 IPG contains electronics and a battery that are sealed inside a titanium case. The IPG is implanted subcutaneously, below the clavicle in the upper chest, and connect to the stimulation lead and sensing lead. The Model 3028 does not contain any software or firmware. All functions including the telemetry and algorithm have been designed into the hardware of the IPG. The algorithm synchronizes stimulation of the hypoglossal nerve with respiration signals. The IPG processes the same dynamic range of pressure signals (2-48 cmH2O) in order to account for pressure reading variability. Based on typical settings from the STAR pivotal trial, the longevity of the Model 3028’s battery will average 10 years although the device is smaller than the currently approved version (Model 3024). In addition the Model 3028 IPG will allow patients to safely undergo magnetic resonance imaging (MRI) under specified conditions.

  Inspire Medical Systems, Inc.

  2020-10-15

• Inspire - The Model 3024 Inspire II IPG contains electronics and a battery that are sealed inside a titanium case. The IPG is implanted subcutaneously below the clavicle in the upper chest, and connects to the stimulation lead and sensing lead. The IPG has multiple programmable parameters that can be adjusted for a particular patient. Adjustments may be made to the sensing circuits to vary the timing of stimulation pulses and to the stimulation circuits to adjust the energy and duration of stimulation pulses. These adjustments provide the ability to optimize the opening of the upper airway. Based on typical settings from the STAR pivotal trial the longevity of the IPG’s battery will average 10 years. The Model 3024 IPG was originally developed by Medtronic and utilizes the same platform as Medtronic’s Itrel® 3 IPG which is FDA approved for other neurostimulation therapies. Figure 9 provides a photograph of the Model 3024 IPG.

  Inspire Medical Systems, Inc.

  2017-10-02

• Inspire - The Model 2740 physician programmer is designed for use by a physician to non‐invasively interrogateand program the IPG. It is the only component in the Inspire system that contains software. Thisprogrammer consists of a tablet computer and a telemetry cable. The telemetry head communicateswith the IPG through the skin via short‐range radio‐frequency (RF) telemetry; telemetry communicationallows the physician to noninvasively interrogate and program the IPG. The telemetry head is poweredby a wall outlet connection and wirelessly communicates (via wireless Bluetooth link) with the physicianprogrammer tablet. The physician programmer has the capability to monitor respiratory waveforms,program stimulation modes, adjust stimulation parameter values, and store waveforms and settings.

  Inspire Medical Systems, Inc.

  2017-07-14

• Inspire - The Model 2740 physician programmer is designed for use by a physician to non‐invasively interrogateand program the IPG. It is the only component in the Inspire system that contains software. Thisprogrammer consists of a tablet computer and a telemetry cable. The telemetry head communicateswith the IPG through the skin via short‐range radio‐frequency (RF) telemetry; telemetry communicationallows the physician to noninvasively interrogate and program the IPG. The telemetry head is poweredby a wall outlet connection and wirelessly communicates (via wireless Bluetooth link) with the physicianprogrammer tablet. The physician programmer has the capability to monitor respiratory waveforms,program stimulation modes, adjust stimulation parameter values, and store waveforms and settings.

  Inspire Medical Systems, Inc.

  2017-01-16

• Inspire - The Model 2740 physician programmer is designed for use by a physician to non‐invasively interrogateand program the IPG. It is the only component in the Inspire system that contains software. Thisprogrammer consists of a tablet computer and a telemetry cable. The telemetry head communicateswith the IPG through the skin via short‐range radio‐frequency (RF) telemetry; telemetry communicationallows the physician to noninvasively interrogate and program the IPG. The telemetry head is poweredby a wall outlet connection and wirelessly communicates (via wireless Bluetooth link) with the physicianprogrammer tablet. The physician programmer has the capability to monitor respiratory waveforms,program stimulation modes, adjust stimulation parameter values, and store waveforms and settings.

  Inspire Medical Systems, Inc.

  2017-01-16

• Inspire - The Model 2740 physician programmer is designed for use by a physician to non‐invasively interrogateand program the IPG. It is the only component in the Inspire system that contains software. Thisprogrammer consists of a tablet computer and a telemetry cable. The telemetry head communicateswith the IPG through the skin via short‐range radio‐frequency (RF) telemetry; telemetry communicationallows the physician to noninvasively interrogate and program the IPG. The telemetry head is poweredby a wall outlet connection and wirelessly communicates (via wireless Bluetooth link) with the physicianprogrammer tablet. The physician programmer has the capability to monitor respiratory waveforms,program stimulation modes, adjust stimulation parameter values, and store waveforms and settings.

  Inspire Medical Systems, Inc.

  2017-01-16

• Inspire - The sleep remote is an external device that is about the size of a cell phone and is used by the patient to activate the Inspire system before they go to sleep. The patient places the remote over the implanted IPG site, and uses push buttons on top of the programmer to: a.) turn the therapy ON or OFF, b.) temporarily suspend therapy, or c.) make adjustments to the stimulation strength (within limits set by the physician). The patient’s sleep remote also allows patients to check the status of the IPG battery. There are both visual and audio indicators that provide information on the IPG status (therapy ON/OFF, therapy paused, stimulation level and battery status). The Inspire sleep remote will only communicate with the Inspire IPG.

  Inspire Medical Systems, Inc.

  2016-06-28

• Inspire - The sleep remote is an external device that is about the size of a cell phone and is used by the patient to activate the Inspire system before they go to sleep. The patient places the remote over the implanted IPG site, and uses push buttons on top of the programmer to: a.) turn the therapy ON or OFF, b.) temporarily suspend therapy, or c.) make adjustments to the stimulation strength (within limits set by the physician). The patient’s sleep remote also allows patients to check the status of the IPG battery. There are both visual and audio indicators that provide information on the IPG status (therapy ON/OFF, therapy paused, stimulation level and battery status). The Inspire sleep remote will only communicate with the Inspire IPG.

  Inspire Medical Systems, Inc.

  2016-06-15

• Inspire - The sensing lead incorporates a differential pressure sensor that detects respiratory cycles. The connector end of the lead is connected to the IPG. The sensor is implanted in between the intercostal muscle layers. The device senses relative pressure variations that correspond to the respiration cycle. The pressure waveform is monitored by the IPG and triggers stimulation therapy synchronous with inspiration

  Inspire Medical Systems, Inc.

  2017-10-02

• Inspire - The stimulation lead incorporates a cuff segment that includes three electrodes in a guarded-bipolar configuration, which means the center electrode is connected to one pole of the stimulation (e.g., negative pole), and is flanked on each side by two electrodes connected to the opposite pole of stimulation (e.g., positive pole). It is packaged with a tunneling rod to facilitate the implant procedure. The cuff is surgically positioned around a patient’s hypoglossal nerve, and the connector end of the lead is connected to the IPG. The cuff electrodes apply electrical current that stimulates the nerve causing the tongue to move forward. The tongue movement (via genioglossus and other tongue protrusor muscle contraction) serves to maintain an open airway. The figure below provides an illustration of the Model 4063 stimulation lead.

  Inspire Medical Systems, Inc.

  2017-10-02

• Inspire - The Model 2740 physician programmer is designed for use by a physician to non-invasively interrogate and program the IPG. It is the only component in the Inspire system that contains software. This programmer consists of a tablet computer and a telemetry cable. The telemetry head communicates with the IPG through the skin via short-range radio-frequency (RF) telemetry; telemetry communication allows the physician to noninvasively interrogate and program the IPG. The telemetry head is powered by a wall outlet connection and wirelessly communicates (via wireless Bluetooth link) with the physician programmer tablet. The physician programmer has the capability to monitor respiratory waveforms, program stimulation modes, adjust stimulation parameter values, and store waveforms and settings. This data can also be printed via a wireless Bluetooth link to a commercial printer.

  Inspire Medical Systems, Inc.

  2015-04-01

• Inspire - The Model 2740 physician programmer is designed for use by a physician to non-invasively interrogate and program the IPG. It is the only component in the Inspire system that contains software. This programmer consists of a tablet computer and a telemetry cable. The telemetry head communicates with the IPG through the skin via short-range radio-frequency (RF) telemetry; telemetry communication allows the physician to noninvasively interrogate and program the IPG. The telemetry head is powered by a wall outlet connection and wirelessly communicates (via wireless Bluetooth link) with the physician programmer tablet. The physician programmer has the capability to monitor respiratory waveforms, program stimulation modes, adjust stimulation parameter values, and store waveforms and settings. This data can also be printed via a wireless Bluetooth link to a commercial printer.

  Inspire Medical Systems, Inc.

  2014-11-20

• Inspire - The Model 2740 physician programmer is designed for use by a physician to non-invasively interrogate and program the IPG. It is the only component in the Inspire system that contains software. This programmer consists of a tablet computer and a telemetry cable. The telemetry head communicates with the IPG through the skin via short-range radio-frequency (RF) telemetry; telemetry communication allows the physician to noninvasively interrogate and program the IPG. The telemetry head is powered by a wall outlet connection and wirelessly communicates (via wireless Bluetooth link) with the physician programmer tablet. The physician programmer has the capability to monitor respiratory waveforms, program stimulation modes, adjust stimulation parameter values, and store waveforms and settings. This data can also be printed via a wireless Bluetooth link to a commercial printer.

  Inspire Medical Systems, Inc.

  2014-09-24

• Inspire - The patient programmer is an external device that is about the size of a cell phone or PDA, and is used by the patient to activate the Inspire system before they go to sleep. The patient places the programmer over the implanted IPG site, and uses push buttons on top of the programmer to: a.) turn the therapy ON or OFF, b.) temporarily suspend therapy, or c.) make adjustments to the stimulation amplitude (within limits set by the physician). The patient programmer also allows patients to check the status of the IPG battery. There are both visual and audio indicators that provide confirmation of IPG status (Therapy ON/OFF and Battery Status). The patient programmer will only communicate with the Inspire system IPG

  Inspire Medical Systems, Inc.

  2014-09-24

• Inspire - The Model 3024 Inspire II IPG contains electronics and a battery that are sealed inside a titanium case. The IPG is implanted subcutaneously below the clavicle in the upper chest, and connects to the stimulation lead and sensing lead. The IPG has multiple programmable parameters that can be adjusted for a particular patient. Adjustments may be made to the sensing circuits to vary the timing of stimulation pulses and to the stimulation circuits to adjust the energy and duration of stimulation pulses. These adjustments provide the ability to optimize the opening of the upper airway. Based on typical settings from the STAR pivotal trial the longevity of the IPG’s battery will average 10 years. The Model 3024 IPG was originally developed by Medtronic and utilizes the same platform as Medtronic’s Itrel® 3 IPG which is FDA approved for other neurostimulation therapies. Figure 9 provides a photograph of the Model 3024 IPG.

  Inspire Medical Systems, Inc.

  2014-09-24

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