ResMed AirCurve 11 Launches Bilevel Sleep Apnea Treatment Device Owner’s Manual

ResMed AirCurve 11 Launches Bilevel Sleep Apnea Treatment Device

From the sleep and respiratory care therapy brand most trusted by sleep physicians1 comes ResMed AirCurve™ 11, a new bilevel series that takes therapy to the next level.

For patients who benefit from pressure support

AirCurve 11 VAuto and ASV* enable providers to make informed decisions about care and help drive positive therapy outcomes, and provide trusted algorithms and personalized patient support

Bilevel therapy provides two levels of support, inspiratory positive airway pressure (IPAP) and expiratory positive airway pressure (EPAP).

AirCurve 11 VAuto bilevel PAP devices treat patients with obstructive sleep apnea and help those struggling to adhere to PAP therapy.

**AirCurve 11 ASV*** offers personalized therapy for patients presenting with central sleep apnea (CSA), obstructive sleep apnea, mixed apneas and periodic breathing.

• HCPC: E0470
  

• HCPC:E0471
  

These new devices combine the trusted algorithms of AirCurve 10 with ResMed Air11 features.

ASV therapy is contraindicated in patients with chronic, symptomatic heart failure (NYHA 2-4) with reduced left ventricular ejection fraction (LVEF ≤ 45%) and moderate to severe predominant central sleep apnea.

Next-level support for patients and providers

With the inclusion of proven Air11 features, AirCurve 11 VAuto and AirCurve 11 ASV* equip patients and care teams with more tools to help them succeed.

AirCurve 11 VAuto

Some patients fi nd it challenging to adapt to CPAP therapy as they are unable to breathe against a continuous flow of air at a set pressure level. Adjusting becomes even harder when CPAP pressures must be higher to maintain airway patency. As a bilevel PAP device, AirCurve 11 VAuto is designed to improve comfort and help compliance by providing a higher pressure during inhalation and a lower pressure during exhalation. This design allows the device to align more closely with the patient’s natural breathing pattern.

VAuto algorithm

VAuto features the Easy-Breathe waveform and renowned ResMed AutoSet™ algorithm—a widely clinically studied algorithm in the field of sleep- disordered breathing (SDB). VAuto continually monitors each patient’s unique breathing pattern on a breath-by-breath basis. The algorithm makes automatic adjustments to treat patients effectively and in the most comfortable way throughout the night. Working in sync with TiControl™, Vsync ensures patient–device synchrony even in conditions of high leak. Key elements of the algorithm include.

1. Auto EPAP Min EPAP and max IPAP set the pressure ranges in which the Autoes algorithm can operate in response to flow limitation, snore, and obstructive apneas. This ensures a patient only receives the amount of pressure they need to optimize therapy.
2. Pressure support Pressure support sets the difference between inspiratory and expiratory pressure and is fixed throughout the night.
3. Cycle sensitivity The default cycle sensitivity setting is appropriate for most patients. However, for patients who might exhibit discomfort and synchrony challenges, trigger sensitivity can be adjusted to support initiation of IPAP with less patient effort. For patients who experience excessive or unintentional leak, cycle sensitivity enables fi ne-tuned sensing of the completion of the breath or patient exhalation.
4. Ti Controls The default Ti Controls settings are appropriate for most patients. However, adjustments allow the clinician to set the Ti minimum and Ti maximum limits. These can play a significant role in maximizing synchronization by effectively intervening to limit or prolong the inspiratory time when required.

The VAuto algorithm is proven to have a positive effect on sleep quality and daytime sleepiness for patients switching from continuous pressure to ResMed VAuto bilevel therapy.5

AirCurve 11 ASV*

Standard therapies are often unable to fully normalize breathing for patients with pauses in breathing due to the absence of respiratory effort. These patients may present with central sleep apnea, obstructive sleep apnea, mixed apneas or periodic breathing, leading to discomfort and arousals. ResMed’s adaptive servo-ventilation (ASV* ) device offers personalized therapy for these patients.

ASVAuto algorithm

Tracking 13 points on every breath cycle 50 times per second, the ASVAuto algorithm is designed to use each patient’s unique minute ventilation target and respiratory rate to deliver therapy that stabilizes ventilation. Continuously monitoring the shape of the patient’s breath informs the algorithm at what points trigger and cycle are occurring, and the length of inspiration, making therapy feel like the patient’s own breath. Key elements of the algorithm include:

1. Auto-adjusting inspiratory pressure support Designed to counterbalance ventilatory instability, pressure support auto-adjusts to maintain each patient’s unique minute ventilation target (tidal volume and respiratory rate) while maintaining patient-device synchrony and comfort.
2. Auto EPAP Generated by ResMed’s proven AutoSet algorithm that responds to fl ow limitation, snoring and obstructive apneas, AirCurve ASV auto-adjusts expiratory positive airway pressure (EPAP) to maintain upper airway patency.
3. Auto backup rate Uses breath phase mapping to provide a timed backup rate synchronized with the patient’s own breathing to maintain the target minute ventilation in the case of apneas.
   
   

ASV therapy is contraindicated in patients with chronic, symptomatic heart failure (NYHA 2-4) with reduced left ventricular ejection fraction (LVEF ≤ 45%) and moderate to severe predominant central sleep apnea.

AirCurve 11 highlights

AirCurve 11 bilevel devices are designed to help improve the patient therapy experience while also helping you achieve your business goals through a powerful combination of features and settings.

Sleep disordered breathing therapy matrix

ongoing effort to breathe. It occurs when the upper airway collapses during sleep, usually due to muscle and soft tissue relaxation.| CSA occurs when the neurological control of breathing is impaired. The upper airway is not necessarily blocked. Instead, pauses in breathing occur due to the absence of respiratory effort. CSA can also be associated with periodic irregular breathing. The most common type of periodic breathing is Cheyne-Stokes Respiration or CSR, in which central apneas alternate with periods of over breathing or hypopneas.
Therapy goals| Maintain airway patency and reliable breath synchronization even in the face of variable mask and mouth leaks. Bilevel therapy can improve comfort and help compliance by more naturally mimicking normal breathing where inhalation requires more effort than exhalation.| Counterbalance ventilator instability by automatically adjusting inspiratory pressure support, reduce respiratory events, and address upper airway collapse. Standard therapies are often unable to fully normalize breathing, which leads to discomfort and arousals.
Therapy modality| Automatic bilevel therapy provides two levels of support, an inspiratory positive airway pressure (IPAP) and expiratory positive airway pressure (EPAP) based on the recognition of obstructive events such as flow limitation, snoring and obstructive apneas, automatically adjust to provide effective treatment.| Bilevel servo-ventilation (ASV*) offers a backup rate. In addition to bilevel pressure settings, an inspiratory positive airway pressure (IPAP) and expiratory positive airway pressure (EPAP), the servo- ventilation algorithm is capable of leaning a patient’s ventilatory pattern and adjusting pressure delivery to maintain stable ventilation.
CMS requirements| One of the following:

1. AHI or RDI >= 15 events /hr; min of 30 events; or,
2. AHI or RDI >= 5 and <=14 events/hr with min of 10 events and documentation of excessive daytime sleepiness, impaired cognition, mood disorders, or insomnia; or, hypertension, ischemic heart disease or history of stroke

| Prior to initiating therapy, a complete facility-based, attended PSG was performed documenting both of the following:

1. Diagnosis of CSA or CompSA and
2. Significant improvement of the sleep-associated hypoventilation with use of an E0470 or E0471 on the settings the physician prescribed for initial use at home while breathing the usual FiO2

AirCurve 11 VAuto and ASV*

sleep apnea, mixed apneas and periodic breathing
Operating pressure range (cm H2O)| 3-25| 4-25
ResMed device therapy modes| CPAP, S, VAuto| CPAP, ASV*, ASVAuto
Features| VAuto mode| ASVAuto mode
---|---|---
CSA detection| X|
Vsync automatic leak management| X|
Adjustable trigger and cycle sensitivity| X|
Adjustable TiControls (Ti Max/Ti Min)| X|
Auto-adjustment of pressure for OSA events| X| X

Device ordering information

AirCurve 11 accessory ordering information

Take bilevel therapy to the next level with the AirCurve 11 bilevel series. With trusted algorithms, insights and robust patient support tools, you can make informed decisions about patient care to help improve therapy outcomes and encourage compliance.

**Speak with your sales representative to learn more about AirCurve 11 VAuto and ASV***

• ASV therapy is contraindicated in patients with chronic, symptomatic heart failure (NYHA 2-4) with reduced left ventricular ejection fraction (LVEF ≤ 45%) and moderate to severe predominant central sleep apnea.
• Coaching entails personalized feedback to encourage continuation of therapy. This is not a healthcare service and is not performed by licensed healthcare providers. Patients are encouraged to speak with their treating clinicians for any clinical symptoms or medical conditions.
• The myAir by ResMed app is available in English and Spanish in the US. The myAir for Canada by ResMed app is available in English and French in Canada.
• Some features of myAir are only available in the myAir app and with Air11 devices.
• Patient consent required for Care Check-In.
  1 ResMed study of board certified sleep physicians in the U.S. Study conducted August 12 – September 6, 2022. n=200. 2 Malhotra et al, “Patient engagement using new technology to improve adherence to positive airway pressure therapy:
  A retrospective analysis,” CHEST 153, no. 4 (Apr 2018): 843–850. 3 ResMed market research survey results of US AirSense 11 PAP device users. AirSense 11 is part of the Air11 platform. Survey conducted July 2021. n=78. 4 ResMed analysis of Care Check-In data of patients using a ResMed AirSense 11 device and who have at least 90 days of therapy data. Data collected April 16, 2021 – May 12, 2022. n=12,409. Actual results may vary. 5 Palot A et al, “Effect of switching from… in patients with OSA,” J Thorac Dis. 2023 Feb 28;15(2):918-927. 6 Morgen-Thaler et al. Randomized controlled trial: The Complex Sleep Apnea Resolution Study: CPAP vs. ASV. Sleep 1999 (Abstract). 7 ResMed study of board certified sleep physicians in the U.S. Study conducted August 12 – September 6, 2022. n=200. 8 Kline LR et al. Compared with cold passover humidification. NCPAP Acceptance and Compliance is altered by humidification. Sleep 1999 (Abstract). 9 Nilius et al.
  Impact of a controlled heated tube humidifier on sleep quality during CPAP therapy in a cool sleeping environment. Eur Respir J 2008; 31: 830-836

Distributed by ResMed Corp, 9001 Spectrum Center Boulevard, San Diego, CA 92123 USA. 858-836-5000 or 800-424-0737 (toll-free). See ResMed.com for other ResMed locations worldwide. Air10, Air11, AirCurve, AirSense, AirView,
AutoRamp, AutoSet, ClimateLineAir, Easy-Breathe, EPR, HumidAir, myAir, SlimLine and SmartStart are trademarks and/or registered trademarks of the ResMed family of companies. Bluetooth is a trademark of Bluetooth SIG, Inc., registered in the US and other countries. Specifications may change without notice. For patent and other intellectual property information, see ResMed.com/ip. © 2024 ResMed. 10113730/1 2024-01

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References

• Sleep apnea and COPD - learn about symptoms and treatment | ResMed
• Legal disclaimers and intellectual property - ResMed

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