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Aerogen Clinical White Paper

Aerogen Clinical White Paper
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Aerogen Clinical White Paper

Product catalog summary
Abstract
Aerogen's vibrating mesh technology is extensively used in hospitals for various ventilatory supports, such as mechanical ventilation, HFOV, NIV, and HFNC. It delivers significantly higher drug doses compared to standard small volume nebulizers (SVNs), enhancing cost-effectiveness and clinical outcomes, especially in pediatric respiratory failure and emergency departments.

High Efficiency Aerosol Drug Delivery During Ventilation
Aerogen devices, using vibrating mesh technology, efficiently deliver aerosol drugs during respiratory support, outperforming standard SVNs, particularly when placed before the humidifier in the ventilator circuit. This reduces residual drug volume, improving cost-effectiveness.

Lung Recruitment Strategy for Patients with Respiratory Failure Utilizing Aerogen
While pMDIs and Aerogen have similar delivery efficiency, Aerogen provides a higher emitted dose. Switching from MDIs to Aerogen results in significant cost savings, with aerosolized Albuterol improving lung function in pediatric respiratory failure.

Superior Drug Deposition During HFOV
HFOV poses challenges for aerosol delivery, but Aerogen technology enhances drug deposition when positioned near the patient, outperforming standard SVNs.

Optimal Drug Delivery During NIV & HFNC
Aerogen devices deliver higher aerosol doses during NIV and HFNC than SVNs. Positioning the device on the patient side of the leak valve increases efficiency, with studies confirming higher lung doses.

Aerogen Aerosol Drug Delivery Technology for Non-Vented Patients
The Aerogen Ultra provides effective aerosol therapy for spontaneously breathing patients using mouthpieces and masks, suitable for both pediatric and adult patients.

Summary
Aerogen's vibrating mesh technology offers superior aerosol drug delivery across various respiratory support systems, improving clinical outcomes and providing cost savings over traditional methods.
Introduction
This document discusses the Aerogen Ultra, a device designed for efficient aerosol drug delivery in respiratory treatments, highlighting its superior performance compared to standard SVNs in clinical settings.

Specifications and Performance
The Aerogen Ultra uses a vibrating mesh system to enhance drug delivery efficiency, delivering up to 35% of the inhaled dose without added flow and maintaining 15% efficiency with additional flow, outperforming SVNs.

Clinical Efficiency
Studies show the Aerogen Ultra delivers medication more quickly and effectively than SVNs, providing over eight times the medication in nearly half the time in a COPD model. Scintigraphy studies confirmed a 4-6 fold increase in lung deposition compared to SVNs.

Clinical Outcomes
In emergency departments, the Aerogen Ultra significantly improved clinical outcomes, with a 32% lower hospital admission rate and a 30% higher discharge rate compared to SVNs. The median length of stay was reduced by 37 minutes, and the required Albuterol dose was significantly lower.

Cost and Efficiency
The Aerogen Ultra improves clinical outcomes and offers substantial cost savings, enhancing patient care and reducing the need for invasive interventions in intensive care and surgeries.

Conclusion
The Aerogen Ultra provides superior aerosol therapy across various clinical settings, offering health and economic benefits. Its advanced technology ensures optimal drug delivery, making it a valuable tool in respiratory care.
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Catalog excerpts

Aerogen Clinical White Paper-1

Pioneering Aerosol Drug Delivery

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Aerogen Clinical White Paper-2

2 High Efficiency Aerosol Drug Delivery During 2 Ventilation 3 A Lung Recruitment Strategy for Patients with 5 Respiratory Failure utilizing Aerogen 4 Comparison of Aerogen with MDIs 5 5 Superior Drug Deposition During HFOV 6 6 Optimal Drug Delivery During NIV & HFNC 7 7 Aerogen Aerosol Drug Delivery Technology 12 for Non-Vented Patients 8 Aerogen Improves Clinical Outcomes in the 16

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Aerogen Clinical White Paper-3

Aerogen’s vibrating mesh technology, available within the Aerogen® Solo, Aerogen® Pro and NIVO has been adopted for use across many areas of the hospital during a variety of ventilatory support including conventional mechanical ventilation, high frequency oscillatory ventilation, non-invasive ventilation and high flow nasal cannula. Clinical researchers have established its superior performance in bench and imaging studies1-13' Aerogen devices can provide the patient with up to 9 fold higher drug dose than a standard small volume nebulizer (SVN) during mechanical ventilation2. In pediatric patients...

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Aerogen Clinical White Paper-4

/ High Efficiency Aerosol Drug Delivery During Ventilation Aerogen devices are highly efficient vibrating mesh aerosol drug delivery systems which can be used inline during any type of respiratory support including mechanical ventilation, high frequency oscillatory ventilation (HFOV), non-invasive ventilation (NIV), continuous positive airway pressure (CPAP) and High Flow Nasal Cannula (HFNC)1-4 7 2(7 23. The Aerogen Solo utilizes active vibrating mesh technology, where energy applied to the vibrational element, causes vibration of each of the 1((( funnel shaped apertures within the mesh. The...

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Aerogen Clinical White Paper-5

Drug Dose, % Figure 1 C omparison of drug deposition after aerosol therapy through a ventilation circuit with standard small volume nebulizers, ultrasonic and the Aerogen Solo. The position of the nebulizer tested included: at the wye and before the humidifier (closer to the ventilator). In this pediatric model of mechanical ventilation with bias flow the Aerogen Solo outperforms both small volume nebulizers in both positions in the ventilator circuit. *p<0.001. Adapted from 2. Clinical White Paper

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Aerogen Clinical White Paper-6

Physiological lung dose was studied in an infant animal The superior drug deposition available with Aerogen model, where quantification of radiolabeled aerosol is associated with the minimal residual volume left in was measured after inhalation through a ventilator the device after nebulization. Standard small volume circuit, tested with both a small volume nebulizer and nebulizers on average leave up to half of the drug the Aerogen Pro. The Aerogen Pro demonstrated a 25 behind which can be quite costly when using more fold higher deposition of aerosol in the lungs compared expensive drugs24....

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Aerogen Clinical White Paper-7

3 Lung Recruitment Strategy for Patients with Respiratory Failure utilizing Aerogen Strategies to improve lung recruitment in patients with acute respiratory distress syndrome (ARDS) and respiratory failure can include the use of B-agonists. These drugs are used extensively to treat hypoxemic ventilated patients even without a confirmed clinical benefit. A recent study has investigated whether providing inhaled Albuterol delivered by Aerogen technology can improve the lung function of pediatric patients14. Compared to baseline, aerosolized Albuterol improved the functional residual capacity of...

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Aerogen Clinical White Paper-8

Superior Drug Deposition during HFOV HFOV has historically been a challenge for aerosol administration. It represents another ventilation mode where aerosol can be delivered during the therapy with Aerogen technology. In an in vitro model of adult, pediatric and infant ventilation, Fang et al. compared drug deposition during HFOV with the Aerogen Solo in comparison to a standard small volume nebulizer3. Drug deposition was minimal with both devices during HFOV when the nebulizer was placed back at the humidifier. Conversely, the deposition of aerosol in all simulated lung models was significantly...

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Aerogen Clinical White Paper-9

Optimal Drug Delivery During NIV & HFNC The Aerogen device can also be connected to a NIV circuit and can deliver aerosol during NIV and CPAP. Studies have shown that aerosol deposition with the Aerogen Pro connected into the circuit, patient side of the leak valve, provided 2-3 fold more inhaled drug than a standard small volume nebulizer in the same position. The importance of positioning of the nebulizer is observed in this study as the Aerogen Pro efficiency of 51% is reduced to 19% if connected before the leak valve (Figure 4)4. 500 0 Patient side of the leak port Ventilator side of the...

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Aerogen Clinical White Paper-10

Additional studies have confirmed these data with the NIVO, which fits directly into an NIV mask6, 28. In an in vitro comparison of a vibrating mesh (NIVO) vs a small volume nebulizer during NIV, a similar difference in inhaled drug was noted (Figure 5)6. It is also important to note that the efficiency of the Aerogen Solo and NIVO has been directly compared and similar aerosol deposition has been reported29. Inhaled Aerosol During CPAP & Bi-Level NIV (% of Initial Charge) 16 Legend Each data point represents the mean of two test runs. Inhaled Aerosol (% of Initial Charge) Treatment Time (minutes)...

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Aerogen Clinical White Paper-11

Lung dose correlates directly to these in vitro studies. Galindo-Filho et al. completed a scintigraphy study with healthy patients using the NIVO during NIV and quantified the inhaled dose to be 23.1 % for the vibrating mesh and 6.1% with the small volume nebulizer. A lung dose of 5.5% was measured with the vibrating mesh, which was 3-4 fold greater than the 1.5% measured with a standard small volume nebulizer (Figure 6)5. Figure 6 Distribution of aerosol in the lungs of healthy patients after nebulization with a SVN and NIVO. Lung deposition is significantly greater with the NIVO. Adapted from...

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Aerogen Clinical White Paper-12

Aerosol therapy during the use of High Flow Nasal lower flow rates have a favorable effect on aerosol Cannula (HFNC) can be provided by the Aerogen dose7. More recent research into adult HFNC showed Solo inline with a variety of HFNC systems, delivering that placing the Aerogen Solo before the humidifier aerosol directly through the nasal cannula. This provided optimal aerosol therapy in comparison technique allows aerosol delivery without interruption to two small volume nebulizers8. Reminiac at al. of oxygen flow and pressure and is more effective commented that the Aerogen Solo “was associated...

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