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Inspire Medical Systems, Inc.

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Inspire
Inspire Medical Systems, Inc.
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.
0
-
Inspire
Inspire Medical Systems, Inc.
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.
0
-
Inspire
Inspire Medical Systems, Inc.
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
0
-
Inspire
Inspire Medical Systems, Inc.
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.
0
-
Inspire
Inspire Medical Systems, Inc.
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.
0
-
Inspire
Inspire Medical Systems, Inc.
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.
0
-
Inspire
Inspire Medical Systems, Inc.
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.
0
-
Inspire
Inspire Medical Systems, Inc.
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
0
-
Inspire
Inspire Medical Systems, Inc.
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.
0
-
Inspire
Inspire Medical Systems, Inc.
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
0
-
Inspire
Inspire Medical Systems, Inc.
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
0
-
Inspire
Inspire Medical Systems, Inc.
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.
0
-
Inspire
Inspire Medical Systems, Inc.
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
0
-
Inspire
Inspire Medical Systems, Inc.
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.
0
-
Inspire
Inspire Medical Systems, Inc.
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
0
-
Inspire
Inspire Medical Systems, Inc.
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.
0
-
Inspire
Inspire Medical Systems, Inc.
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.
0
-
Inspire
Inspire Medical Systems, Inc.
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
0
-
Inspire
Inspire Medical Systems, Inc.
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.
0
-
Inspire
Inspire Medical Systems, Inc.
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.
0
-
Inspire
Inspire Medical Systems, Inc.
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.
0
-
Inspire
Inspire Medical Systems, Inc.
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.
0
-
Inspire
Inspire Medical Systems, Inc.
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.
0
-
Inspire
Inspire Medical Systems, Inc.
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).
0
-
Inspire
Inspire Medical Systems, Inc.
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.
0
-
Inspire
Inspire Medical Systems, Inc.
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.
0
-
Inspire
Inspire Medical Systems, Inc.
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.
0
-
Inspire
Inspire Medical Systems, Inc.
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.
0
-
Inspire
Inspire Medical Systems, Inc.
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.
0
-
Inspire
Inspire Medical Systems, Inc.
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.
0
-
Inspire
Inspire Medical Systems, Inc.
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.
0
-
Inspire
Inspire Medical Systems, Inc.
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.
0
-
Inspire
Inspire Medical Systems, Inc.
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.
0
-
Inspire
Inspire Medical Systems, Inc.
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.
0
-
Inspire
Inspire Medical Systems, Inc.
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.
0
-
Inspire
Inspire Medical Systems, Inc.
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
0
-
Inspire
Inspire Medical Systems, Inc.
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.
0
-
Inspire
Inspire Medical Systems, Inc.
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.
0
-
Inspire
Inspire Medical Systems, Inc.
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.
0
-
Inspire
Inspire Medical Systems, Inc.
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.
0
-
Inspire
Inspire Medical Systems, Inc.
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
0
-
Inspire
Inspire Medical Systems, Inc.
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.
0
-
Inspire
Inspire Medical Systems, Inc.
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.
0
-
Inspire
Inspire Medical Systems, Inc.
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.
0
-
Inspire
Inspire Medical Systems, Inc.
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.
0
-
Inspire
Inspire Medical Systems, Inc.
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.
0
-
Inspire
Inspire Medical Systems, Inc.
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.
0
-
Inspire
Inspire Medical Systems, Inc.
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.
0
-
Inspire
Inspire Medical Systems, Inc.
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.
0
-
Inspire
Inspire Medical Systems, Inc.
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.
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