| Device | Inspire® Upper Airway Stimulation (UAS) |
|---|---|
| Generic Name | Stimulator, hypoglossal nerve, implanted, apnea |
| Applicant | INSPIRE MEDICAL SYSTEMS 9700 63RD AVENUE NORTH SUITE 200 MAPLE GROVE, MN 55369 |
| PMA Number | P130008 |
| Supplement Number | S120 |
| Date Received | 03/26/2025 |
| Decision Date | 04/23/2025 |
| Product Code | MNQ |
| Advisory Committee | Anesthesiology |
| Supplement Type | 30-Day Notice |
| Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Expedited Review Granted? | No |
| Combination Product | No |
| Approval Order Statement notification of a change to the weld block plating supplier | |
28
P130008/S120 review time is faster than 67.1% of similar devices* and 3.4% faster than the median.
* Similar Devices - Devices that share the same advisory committee and supplement type.
| Suppl. # | Suppl. Type & Reason | Approval Order Statement | Received | Decision |
|---|---|---|---|---|
| S107 | 30-Day Notice Process Change - Manufacturer/Sterili - zer/Packager/Supplier |
The change associated with this submission is to remove the time-bounded 72 hours testing window between burn in and functional test. if the units exceed 96 hours (24 hours cool down + 72 hours in scope of this submission) after burn-in, the units need to complete an additional 24-hour burn-in and 24-hour cooldown prior to functional test. |
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| S106 | 30-Day Notice Process Change - Manufacturer/Sterili - zer/Packager/Supplier |
Approval to utilize laser welders ipg-003, ipg-004 and ipg-005 to perform hybrid welds in the manufacturing of the inspire model 3028 ipg |
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| S105 | 30-Day Notice Process Change - Manufacturer/Sterili - zer/Packager/Supplier |
Approval for updates to work instructions used to manufacture the model 4340 sensing lead and 4063 stimulation lead |
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| S104 | 30-Day Notice Process Change - Manufacturer/Sterili - zer/Packager/Supplier |
Approval of changes in the arrangement and thickness of wires within the bare cable component of programmer cable (models 2740 and 2740c) |
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| S103 | 135 Review Track For 30-Day Notice Process Change - Manufacturer/Sterili - zer/Packager/Supplier |
The changes to the model 3028 implantable pulse generator (ipg) assembly epoxy fill instructions |
||
| S102 | 30-Day Notice Process Change - Manufacturer/Sterili - zer/Packager/Supplier |
Changes to the equipment used in the manufacturing process for the sensor component of the model 4340 sensing lead |
||
| S101 | Real-Time Process Change Design/Components/Sp - ecifications/Material |
Approval for design changes for model 2740 and 2740c inspire programmer cables. | ||
| S100 | 30-Day Notice Process Change - Manufacturer/Sterili - zer/Packager/Supplier |
Changes to the manufacturing of the is-1 connector end, which is part of both the model 4063 stimulation lead and model 4340 sensing lead. |
||
| S099 | Normal 180 Day Track No User Fee Postapproval Study Protocol |
Approval of the protocol for the post-approval study (pas) protocol. | ||
| S097 | 30-Day Notice Process Change - Manufacturer/Sterili - zer/Packager/Supplier |
Change in manufacturing location for three injection-molded components of the device. |
||
| S096 | Normal 180 Day Track No User Fee Postapproval Study Protocol |
Approval of the protocol for the post-approval study (pas) protocol. | ||
| S095 | Real-Time Process Change Design/Components/Sp - ecifications/Material |
Approval for the change to the model 2740 programmer cable printed circuit board assembly (pcba). |
||
| S094 | 30-Day Notice Process Change - Manufacturer/Sterili - zer/Packager/Supplier |
Notification of the addition of three laser weld stations to be used in the manufacturing of the inspire model 3028 ipg |
||
| S093 | Normal 180 Day Track No User Fee Postapproval Study Protocol |
Approval for the inspire® upper airway stimulation (uas). the device is indicated for use to treat a subset of patients with moderate to severe obstructive sleep apnea (osa) (apnea-hypopnea index [ahi] of greater than or equal to 15 and less than or equal to 65). inspire® uas is used in adult patients 22 years of age and older who have been confirmed to fail or cannot tolerate positive airway pressure (pap) treatments (such as continuous positive airway pressure [cpap] or bi-level positive airway pressure [bpap] machines) and who do not have a complete concentric collapse at the soft palate level.pap failure is defined as an inability to eliminate osa (ahi of greater than 15 despite pap usage), and pap intolerance is defined as:1) inability to use pap (greater than 5 nights per week of usage; usage defined as greater than 4 hours of use per night); or2) unwillingness to use pap (for example, a patient returns the pap system after attempting to use it).inspire® uas is also indicated for use in patients between the ages of 18 and 21with moderate to severe osa (15?ahi?65) who:1) do not have complete concentric collapse at the soft palate level;2) are contraindicated for, or not effectively treated by, adenotonsillectomy;3) have been confirmed to fail, or cannot tolerate, pap therapy despite attempts to improve compliance; and4) have followed standard of care in considering all other alternative/adjunct therapies. |
||
| S092 | Normal 180 Day Track Change Design/Components/Sp - ecifications/Material |
Approval for the updated sleepsync programmer (model 2740) which consists of the inspire programming software application (model 2740s) that can be installed on customer owned devices and paired with the inspire programmer cable (model 2740c). |
||
| S090 | Panel Track Labeling Change - Indications/instructions/shelf Life/tradename |
Approval to expand the indications for use to osa patients with an upper limit baseline apnea-hypopnea index (ahi) to 100 (increase from <= 65 to <=100) and increasing the an upper limit body mass index (bmi) warning to 40 (increase from <=32 to <=40). |
||
| S089 | Panel Track Labeling Change - Indications/instructions/shelf Life/tradename |
Approval for the inspire upper airway stimulation (uas) the device is used to treat a subset of pediatric down syndrome patients between the age of 13-18 with severe osa (apnea-hypopnea index [ahi] of greater than or equal to 10 and less than or equal to 50) who: 1) do not have complete concentric collapse at the soft palate level;2) are contraindicated for or not effectively treated by adenotonsillectomy; 3) have been confirmed to fail, or cannot tolerate positive airway pressure (pap) therapy despite attempts to improve compliance; and4) have followed standard of care in considering all other alternative/adjunct therapies. pap failure is defined as an inability to eliminate osa, and pap intolerance is defined as: a. inability to use pap (greater than 5 nights per week of usage; usage defined as greater than 4 hours of use per night), or b. unwillingness to use pap (for example, a patient returns the pap system after attempting to use it). |
||
| S088 | 30-Day Notice Process Change - Manufacturer/Sterili - zer/Packager/Supplier |
Additional qualified supplier for barium titanate. | ||
| S085 | Real-Time Process Change Design/Components/Sp - ecifications/Material |
Approval for the modification of the main button of the model 2580 patient remote to be slightly smaller |
||
| S084 | 30-Day Notice Process Change - Manufacturer/Sterili - zer/Packager/Supplier |
Notification of replacing obsolete metal- oxide- semiconductor field-effect transistor (mosfet) for the sensor assembly and additional lathe equipment to be used to manufacture the terminal pin used in the connector assembly of the leads for the inspire models 4340 and 4063 respiratory sensing leads |
||
| S083 | 30-Day Notice Process Change - Manufacturer/Sterili - zer/Packager/Supplier |
Additional lathe equipment to be used to manufacture the terminal pin used in the connector assembly of the inspire leads, model 4340 and model 4063, to increase production capacity. |
||
| S082 | 30-Day Notice Process Change - Manufacturer/Sterili - zer/Packager/Supplier |
Notification of implementing automated final functional testing for the model 2580 patient remote. |
||
| S081 | 30-Day Notice Process Change - Manufacturer/Sterili - zer/Packager/Supplier |
Notification of replacing obsolete metal- oxide- semiconductor field-effect transistor (mosfet) for the sensor assembly in the inspire model 4340 respiratory sensing lead. |
||
| S080 | 30-Day Notice Process Change - Manufacturer/Sterili - zer/Packager/Supplier |
Addition of a manufacturing site for the inductor coil used in the model 2580 remote. |
||
| S079 | 30-Day Notice Process Change - Manufacturer/Sterili - zer/Packager/Supplier |
Notification of replacing obsolete components of the inspire model 2740 programmer tablet and updates to the tablet basic input/output system (bios) |
||
| S078 | 30-Day Notice Process Change - Manufacturer/Sterili - zer/Packager/Supplier |
Notification of introducing a multi-cavity mold to manufacture model 2580 patient remote buttons. |
||
| S077 | 30-Day Notice Process Change - Manufacturer/Sterili - zer/Packager/Supplier |
Notification of additional raw material suppliers. | ||
| S076 | Normal 180 Day Track Labeling Change - Indications/instructions/shelf Life/tradename |
Approval for additional mr scanning conditions using a 1.5t full body coil scanner for model 3028 ipg, model 4323, model 4340 and model 4063 leads |
||
| S075 | 30-Day Notice Process Change - Manufacturer/Sterili - zer/Packager/Supplier |
Additional weld equipment, inspections and rework steps in the manufacturing of the inspire model 4340 respiratory sensing lead. |
||
| S074 | Normal 180 Day Track Change Design/Components/Sp - ecifications/Material |
Approval for the model 4063 silicone stimulation lead and the model 4340 silicone sensing lead lengths 25cm and 45cm. |
||
| S073 | Normal 180 Day Track No User Fee Postapproval Study Protocol |
Approval for the revised protocol for the post-approval study (pas) protocol. | ||
| S072 | 135 Review Track For 30-Day Notice Process Change - Manufacturer/Sterili - zer/Packager/Supplier |
Approval for updating the final functional test limit for telemetry drive strength used during the manufacture of the model 2740 programmer cable. |
||
| S071 | 30-Day Notice Process Change - Manufacturer/Sterili - zer/Packager/Supplier |
Process change to increase the allowed upper limit of the range for titanium/niobium sputter thickness. |
||
| S069 | Normal 180 Day Track Change Design/Components/Sp - ecifications/Material |
Approval for the model 2580 sleep remote as a replacement for the model 2500 sleep remote. |
||
| S068 | Real-Time Process Change Design/Components/Sp - ecifications/Material |
Approval for the revision of model 2740 programmer cable firmware to v1.7. | ||
| S067 | 30-Day Notice Process Change - Manufacturer/Sterili - zer/Packager/Supplier |
Modifications to the strain relief molding tool used to manufacture power and antenna cable assemblies for the model 2740 programmer cable. |
||
| S066 | 30-Day Notice Process Change - Manufacturer/Sterili - zer/Packager/Supplier |
Replacement component in the pressure sensor capsule from a new supplier. | ||
| S065 | 135 Review Track For 30-Day Notice Process Change - Manufacturer/Sterili - zer/Packager/Supplier |
Approval for two additional sterilization chambers for the sterilization of model 3028 implantable pulse generator (ipg) at the inspire medical systems incs contract manufacturer/sterilizer, steris isomedix. |
||
| S064 | 30-Day Notice Process Change - Manufacturer/Sterili - zer/Packager/Supplier |
Replace a component on the sensor capsule burn-in fixture and increase the sensor capsule burn-in fixture capacity. |
||
| S063 | Normal 180 Day Track Labeling Change - Indications/instructions/shelf Life/tradename |
Approval for:1) updates to the system implant manual to include an alternative implant technique for the sensing lead ; and2) updates to the mri guidelines in conjunction with the update to the system implant manual |
||
| S062 | 30-Day Notice Process Change - Manufacturer/Sterili - zer/Packager/Supplier |
Changes to the insulation tape application process in the coil of the model 2500 patient sleep remote |
||
| S061 | Real-Time Process Change Design/Components/Sp - ecifications/Material |
Approval for dimensional change on a component of the pressure sensor assembly of the model 4340 sensing lead. |
||
| S060 | 30-Day Notice Process Change - Manufacturer/Sterili - zer/Packager/Supplier |
Changes to the hybrid test system software from version 2.0 to version 2.0.1 to address false test failures due to improper startup of hybrids under test. |
||
| S059 | 30-Day Notice Process Change - Manufacturer/Sterili - zer/Packager/Supplier |
Implementation of a new capillary tool for wire bonding process for the membrane subassembly used in model 4340 sensing lead. |
||
| S058 | 30-Day Notice Process Change - Manufacturer/Sterili - zer/Packager/Supplier |
Change to the cleaning process of model 3028 ipg involving the replacement of trichloroethylene with an alcohol-based solvent. |
||
| S057 | 135 Review Track For 30-Day Notice Process Change - Manufacturer/Sterili - zer/Packager/Supplier |
Approval for the implementation of a new welding process for the model 3028 ipg. | ||
| S056 | Normal 180 Day Track Change Design/Components/Sp - ecifications/Material |
Approval for:1) updated version of the model 2740 inspire programmer system;2) minor software changes to the application module (am)/tablet;3) manufacturing process changes to reduce scrap for the new programmer cable;4) changes to improve aesthetics of the programmer cable; and5) minor software updates regarding non-english languages for the european market and minor bug fixes. |
||
| S055 | Normal 180 Day Track No User Fee Location Change - Manufacturer/Sterili - zer/Packager/Supplier |
Approval of manufacturing site located at cirtec medical, 99 print shop rd, enfield, ct 06082, usa, (for sterilization process for the finished device, inspire model 3028 ipg). |
||
| S054 | 30-Day Notice Process Change - Manufacturer/Sterili - zer/Packager/Supplier |
Changes to the manufacturing of model 4340 respiratory sensing lead involving the addition of a new mrsi die bonder for hermetic pressure sensor assembly membrane and network die bonding process. |
||
| S053 | 30-Day Notice Process Change - Manufacturer/Sterili - zer/Packager/Supplier |
Software update (version 2.0) to the hybrid test system software and new hybrid test system hardware equipment for testing of the model 3028 implantable pulse generator. |
||
| S052 | Normal 180 Day Track No User Fee Postapproval Study Protocol |
Approval of the protocol for the post-approval study (pas) protocol. | ||
| S051 | 30-Day Notice Process Change - Manufacturer/Sterili - zer/Packager/Supplier |
Notification of adding an alternate new supplier for the terminal ferrule used in the battery for model 3028 ipg |
||
| S050 | 30-Day Notice Process Change - Manufacturer/Sterili - zer/Packager/Supplier |
To update design documents of model 4063 stimulation lead and model 4340 sensing lead to clarify manufacturing instructions for silicone adhesive backfill requirements |
||
| S049 | Special (Immediate Track) Labeling Change - Indications/instructions/shelf Life/tradename |
Approval for updates to the inspire system implant manual. | ||
| S048 | 30-Day Notice Process Change - Manufacturer/Sterili - zer/Packager/Supplier |
Updated molding process for the clamping rod of tunneling tool, which is used to tunnel the lead connector from the point of implantation to the ipg pocket. |
||
| S047 | 135 Review Track For 30-Day Notice Process Change - Manufacturer/Sterili - zer/Packager/Supplier |
Approval to update soldermask application process for the pcb component of model 3028 implantable pulse generator (ipg) |
||
| S046 | 30-Day Notice Process Change - Manufacturer/Sterili - zer/Packager/Supplier |
Notification of changes being implemented to test specification gain limits associated with the manufacture of the model 4340 sensing lead. |
||
| S045 | 30-Day Notice Process Change - Manufacturer/Sterili - zer/Packager/Supplier |
Reduce the energy used in the seam welding process of the sensor component of the model 4340 and model 4323 sensor lead at the contract manufacturer cirtec medical. |
||
| S044 | 30-Day Notice Process Change - Manufacturer/Sterili - zer/Packager/Supplier |
Manufacturing change to reduce vacuum bake time for the model 3028 implantable pulse generator prior to case seam welding. |
||
| S043 | Real-Time Process Labeling Change - Indications/instructions/shelf Life/tradename |
Approval for proposed changes to the inspire systems mri guidelines manual. | ||
| S041 | Real-Time Process Change Design/Components/Sp - ecifications/Material |
Approval for a change in the method used to incorporate serial numbers inside the model 4063 leads is-1 connector boot. |
||
| S040 | 30-Day Notice Process Change - Manufacturer/Sterili - zer/Packager/Supplier |
Move manufacturing activities for the model 2740 physician programmer to nortech systems. |
||
| S039 | Panel Track Labeling Change - Indications/instructions/shelf Life/tradename |
Approval for the inspire upper airway stimulation (uas) the device is used to treat a subset of patients with moderate to severe obstructive sleep apnea (osa) (apnea-hypopnea index [ahi] of greater than or equal to 15 and less than or equal to 65). inspire uas is used in adult patients 22 years of age and older who have been confirmed to fail or cannot tolerate positive airway pressure (pap) treatments (such as continuous positive airway pressure [cpap] or bi-level positive airway pressure [bpap] machines) and who do not have a complete concentric collapse at the soft palate level. pap failure is defined as an inability to eliminate osa (ahi of greater than 15 despite pap usage), and pap intolerance is defined as:1) inability to use pap (greater than 5 nights per week of usage; usage defined as greater than 4 hours of use per night); or2) unwillingness to use pap (for example, a patient returns the pap system after attempting to use it).inspire uas is also indicated for use in patients between the ages of 18 and 21with moderate to severe osa (15<=ahi<=65) who: 1) do not have complete concentric collapse at the soft palate level;2) are contraindicated for or not effectively treated by adenotonsillectomy; 3) have been confirmed to fail, or cannot tolerate pap therapy despite attempts to improve compliance; and4) have followed standard of care in considering all other alternative/adjunct therapies. |
||
| S038 | 30-Day Notice Process Change - Manufacturer/Sterili - zer/Packager/Supplier |
Manufacturing equipment upgrades at a vendor that produces a hybrid electronic circuit component for the model 3028 implantable pulse generator. |
||
| S037 | Real-Time Process Change Design/Components/Sp - ecifications/Material |
Approval for a new potting epoxy within the model 3028 ipg. | ||
| S036 | 30-Day Notice Process Change - Manufacturer/Sterili - zer/Packager/Supplier |
Additional laser welder for use in the production of the pressure sensor used in the model 4323 lead. |
||
| S035 | 30-Day Notice Process Change - Manufacturer/Sterili - zer/Packager/Supplier |
Alternate supplier of the pressure sensor component used in the model 4323 pressure sensing lead. |
||
| S034 | Normal 180 Day Track Change Design/Components/Sp - ecifications/Material |
Approval for an update to the tablet hardware and software of the model 2740 physician programmer. |
||
| S033 | Real-Time Process Labeling Change - Indications/instructions/shelf Life/tradename |
Approval for proposed changes to the inspire systems mri guidelines manual. | ||
| S032 | 30-Day Notice Process Change - Manufacturer/Sterili - zer/Packager/Supplier |
Changes to update the model 4323 lead gain and frequency response limits in the test specification. |
||
| S031 | Normal 180 Day Track Change Design/Components/Sp - ecifications/Material |
Approval for a new model 4340 respiratory sensing lead. | ||
| S029 | Normal 180 Day Track No User Fee Labeling Change - PAS |
Approval for updates to the labeling with the results of the extended follow up of the premarket cohort post approval study. |
||
| S028 | 30-Day Notice Process Change - Manufacturer/Sterili - zer/Packager/Supplier |
Changes to update to software version 1.1.9 of the final functional test system for the model 3028 ipg. |
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| S027 | 30-Day Notice Process Change - Manufacturer/Sterili - zer/Packager/Supplier |
Changes to update to software version 1.0.4 of the serial number verification system for the model 3028 ipg. |
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| S026 | 30-Day Notice Process Change - Manufacturer/Sterili - zer/Packager/Supplier |
Changes to the weld blocks/solder paste used in the manufacture of the model 3028 ipg. |
||
| S025 | 30-Day Notice Process Change - Manufacturer/Sterili - zer/Packager/Supplier |
Changes to the serial number test system. | ||
| S024 | 30-Day Notice Process Change - Manufacturer/Sterili - zer/Packager/Supplier |
Changes to the final functional testing of the model 3028 ipg. | ||
| S023 | Real-Time Process Change Design/Components/Sp - ecifications/Material |
Approval for a change to the feedthrough component of the model 4323 sensing lead. |
||
| S022 | Normal 180 Day Track No User Fee Postapproval Study Protocol - OSB |
Approval of the revised protocol for the post-approval study (pas) protocol. | ||
| S021 | Normal 180 Day Track Labeling Change - Indications/instructions/shelf Life/tradename |
Approval to expand the apnea hypopnea index (ahi) range from 20 to 65, to 15 to 65 events per hour. |
||
| S020 | Normal 180 Day Track Process Change - Manufacturer/Sterili - zer/Packager/Supplier |
Approval for an update to the telemetry head of the model 2740 programmer. | ||
| S019 | 30-Day Notice Process Change - Manufacturer/Sterili - zer/Packager/Supplier |
Supplier change for the lead adapter component used in the model 4323 pressure sensing lead. |
||
| S018 | 30-Day Notice Process Change - Manufacturer/Sterili - zer/Packager/Supplier |
Final functional tester in manufacturing model 4323 sensor lead. | ||
| S017 | 30-Day Notice Process Change - Manufacturer/Sterili - zer/Packager/Supplier |
Update to the software application factoryworks to version 9.3. | ||
| S016 | Normal 180 Day Track Change Design/Components/Sp - ecifications/Material |
Approval for the model 3028 mr conditional implantable pulse generator (ipg). | ||
| S015 | 30-Day Notice Process Change - Manufacturer/Sterili - zer/Packager/Supplier |
Implement a change to the manufacturing procedure for annealing of the model 3024 implantable pulse generator (ipg), which adds an in-house annealing process at 1st tier supplier greatbatch medical minneapolis (gmm). |
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| S014 | 30-Day Notice Process Change - Manufacturer/Sterili - zer/Packager/Supplier |
Implementation of additional peel strength testing for the model 3024 implantable pulse generator (ipg) at the contract manufacturer medtronic mproc juncos puerto rico. |
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| S013 | Normal 180 Day Track Change Design/Components/Sp - ecifications/Material |
Approval for an update to the tablet hardware and software of the model 2740 physician programmer. |
||
| S012 | 30-Day Notice Process Change - Manufacturer/Sterili - zer/Packager/Supplier |
Change to replace the machined housing with a new injection molded housing for the model 2740 inspire programmer system (ips) telemetry module box. |
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| S011 | 30-Day Notice Process Change - Manufacturer/Sterili - zer/Packager/Supplier |
Transfer of cleaning process from the medtronic sullivan lake, minneapolis, mn facility (sl) to the medtronic rice creek, minneapolis, mn facility (rc). |
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| S010 | Normal 180 Day Track No User Fee Postapproval Study Protocol - OSB |
Approval of the following changes to the post-approval study for the device: revisions to the protocol to increase the enrollment rate. |
||
| S009 | Normal 180 Day Track Change Design/Components/Sp - ecifications/Material |
Approval for the model 2500 sleep remote (i.e. patient programmer). | ||
| S008 | Real-Time Process Labeling Change - Indications/instructions/shelf Life/tradename |
Approval for extension of the shelf life of the model 3024 implantable pulse generator (ipg) to 3 years. |
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| S007 | 30-Day Notice Process Change - Manufacturer/Sterili - zer/Packager/Supplier |
Implementation of an automated system for inspection of final sealed tray packages and a change in the supplier of gold preform components. |
||
| S006 | 30-Day Notice Process Change - Manufacturer/Sterili - zer/Packager/Supplier |
New post-sterilization test at the firms contract manufacturer. | ||
| S005 | 30-Day Notice Process Change - Manufacturer/Sterili - zer/Packager/Supplier |
Changes to the lead welding, crimping, and molding processes at the firm¿s contract manufacturer. |
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| S004 | 30-Day Notice Process Change - Manufacturer/Sterili - zer/Packager/Supplier |
Install a new cure and preheat oven at the contract manufacturer¿s medtronic puerto rico operations company (mproc) location. |
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| S003 | Normal 180 Day Track No User Fee Postapproval Study Protocol - OSB |
Approval of the post-approval study protocol. | ||
| S002 | Normal 180 Day Track Change Design/Components/Sp - ecifications/Material |
Approval for an update to the tablet hardware and operating system of the model 2740 physician programmer, and related changes to the model 2740 programmer manual. |
||
| S001 | 30-Day Notice Process Change - Manufacturer/Sterili - zer/Packager/Supplier |
Additional assembly process be added. | ||
| Original | Original |
Approval for the inspire upper airway stimulation (uas) system, which includes the model 3024 implantable pulse generator, the model 4063 stimulation lead, the model 4323 sensing lead, the model 2740physician programmer, and the model 3032 patient programmer. the device is used to treat a subset of patients with moderate to severe obstructive sleep apnea (osa) (apnea-hypopnea index [ahi] of greater or equal to 20 and less than or equal to 65). inspire uas is used in adult patients 22 years of age and older who have been confirmed to fail or cannot tolerate positive airway pressure (pap) treatments (such as continuous positive airway pressure [cpap] or bilevel positive airway pressure [bpap] machines) and who do not have a complete concentric collapse at the soft palate level. pap failure is defined as an inability to eliminate osa (ahi of greater than 20 despite pap usage) and pap intolerance is defined as: 1) inability to use pap (greater than 5 nights per week of usage; usage defined as greater than 4 hours of use per night); or 2) unwillingness to use pap (for example, a patient returns the pap system after attempting to use it). |
