New Published Evidence Reinforces the Importance of Device Choice in Asthma Control

Two new publications build on previous evidence that not all devices are equally effective in delivering asthma control.

Plattsburgh, NY, USA — A recent article in Pulmonary Pharmacology and Physiology[1] provides in vitro evidence that the AEROCHAMBER PLUS® FLOW-VU® valved holding chamber (or spacer) delivers aerosolized drug more effectively than other chambers, a view further supported in a new literature review published in Therapeutic Advances in Respiratory Disease.[2]

The use of spacers with Metered Dose Inhalers (MDIs) has become firmly established in the management of asthma and COPD, with guidelines such as the Global Initiative for Asthma (GINA)[3] recommending their use to reduce oropharyngeal deposition of drug and counter the common problem of poor inhaler technique. What is not established, however, is whether there are any meaningful differences between the devices. While GINA guidelines do indicate that not all are the same – a view echoed by the European Medicines Agency (EMA) recommendations,[4] which state that data for MDIs should be generated with a ‘specific named spacer’ – this view is not expressed in all guidelines. Two recent publications set out to address the impact of spacer design on drug delivery performance and look at potential implications for clinical use.

Four similarly sized chambers were compared ‘out of the box’ in terms of statistical equivalence with the gold standard AEROCHAMBER PLUS® chamber with respect to retention of drug particles within the device and the aerodynamic particle size distribution of the drug particles delivered. Only the AEROCHAMBER PLUS® FLOW-VU® chamber (Monaghan Medical Corporation) demonstrated an equivalent profile of dose retention and delivery versus the reference chamber. The Compact Space Chamber Plus† (Medical Developments), the OptiChamber Diamond† (Philips Respironics, Inc), and InspiraChamber† (Lupin Pharmaceuticals, Inc) devices all retained approximately twice as much drug, delivering around half the dose and showing non-equivalent performance compared with the AEROCHAMBER PLUS® FLOW-VU® chamber and reference chamber (pretreated AEROCHAMBER PLUS® chamber).

Lead author, Dr Sanjeeva Dissanayake, has recently published a literature review in Therapeutic Advances in Respiratory Disease, which provides further support for these findings. In considering the important attributes of such delivery devices, the review notes a shift in emphasis from chamber size and shape to other aspects, such as consistency of drug delivery, static charge reduction, valve performance, and factors optimizing facemask effectiveness (such as flexibility and seal). Despite the general lack of published clinical studies that confirm the therapeutic benefits of such differences, the AEROCHAMBER® ‘family’ of chambers has amassed an impressive body of clinical evidence. Most recently, a real-world database study[5] has demonstrated improved clinical benefits and reduced resource utilization use with the AEROCHAMBER PLUS® FLOW-VU® chamber versus other chambers in patients with asthma. A study specifically looking at the FLOW-VU® inhalation indicator has also shown benefits for carer confidence in dose delivery, and improved care-giver preference and quality of life.[6]

Dr Dissanayake commented, ‘The in vitro equivalence study results and the literature review findings provide strong support for the EMA guideline recommendations that data for MDIs should be generated with specific spacer devices, and further reinforce the view that superficially similar chambers should not automatically be considered to be interchangeable – even if superficially similar’.

About Monaghan Medical Corporation (MMC, USA)
MMC offers leading aerosol drug delivery devices and respiratory management products including AEROECLIPSE® II BAN, AEROCHAMBER PLUS® aVHC and the AEROBIKA® device exclusively in the United States. MMC’s strength lies in product development around core capabilities in mechanical design complimented by collaboration with a state-of-the-art aerosol research laboratory. MMC focuses on developing cost-efficient, outcome-based solutions for its customers. (http://www.monaghanmed.com)

About AEROCHAMBER® brand valved holding chambers (VHC), including the AEROCHAMBER PLUS® FLOW-VU® AVHC
Developed in 1983 to address the needs of asthma and COPD patients having difficulty in taking their MDI medications correctly, the AEROCHAMBER® brand of chamber has innovated continuously to improve patient ease of use and quality of life as well as clinical outcomes and healthcare system savings.

• The AEROCHAMBER® brand is the global leader of chambers, with safety and efficacy validated in numerous third party clinical evaluations amongst various patient populations; it is the chamber most recommended by leading MDI pharmaceutical companies.[7]

• AEROCHAMBER PLUS® FLOW-VU® chamber is designed to deliver the intended prescribed dose via the MDI, similar to using an MDI with perfect technique. An additional feature is the incorporation of the FLOW-VU® inspiratory indicator for the care-giver to observe effective inhalation. The FLOW-VU® indicator provides real time feedback confirming an effective inhalation and ensures that there are no leakages of ambient air into the space between facemask and face, that could prevent medication delivery altogether. (http://www.monaghanmed.com)

For clinical inquiries, please contact:
Dominic P. Coppolo, MBA, RRT, FAARC
Vice President Clinical Strategy and Development
Monaghan Medical Corporation
1-800-343-9071

Words or phrases accompanied by ® are trademarks and registered trademarks of Monaghan Medical Corporation or an affiliate of Monaghan Medical Corporation. † trademarks of respective company. © 2018 Monaghan Medical Corporation.

1. Dissanayake S, Nagel M, Falaschetti E, Suggett J. Are valved holding chambers (VHCs) interchangeable? An in vitro evaluation of VHC equivalence. Pulmonary Pharmacology & Therapeutics. 2018; 48:179-184 http://doi.org/10.1016/j.pupt.2017.10.005
2. Dissanayake S, Suggett J. A review of the in-vitro and in-vivo valved holding chamber (VHC) literature with a focus on the AeroChamber Plus Flow-Vu anti-static VHC. Therapeutic Advances in Respiratory Disease. 2018; 12. http://doi.org/10.1177/1753465817751346
3. Global Initiative for Asthma: Global strategy for asthma management and prevention, 2017 Available from: http://www.ginaasthma.org. 2017.
4. Dissanayake S. Application of the EU Guidelines for Pharmacokinetic Studies of Locally Acting Orally Inhaled Drug Products. Respiratory Drug Delivery 2010. Vol 12010:293-304.
5. Burudpakdee, C., Kushnarev, V., Coppolo, D. et al. Pulmonary Therapy. 2017; 3(2):283-96. http://doi.org/10.1007/s41030-017-0047-1
6. Ammari WG, Toor S, Chetcuti P, Stephenson J, Chrystyn H. Evaluation of asthma control, parents’ quality of life and preference between AeroChamber Plus and AeroChamber Plus Flow-Vu spacers in young children with asthma. The Journal of Asthma: Official journal of the Association for the Care of Asthma. 2015;52(3):301-307.
7. AeroChamber brand of holding chambers. Study Summary (September 2017). Available from: http://www.trudellmed.com/aerochamber-study-summary

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Landmark Asthma Study Demonstrates Device Choice Determines Asthma Control

Monaghan Medical Corporation understands that for those with asthma, particularly children, choosing the device that best delivers their medication is an important consideration.

Plattsburgh, NY, USA — Monaghan Medical Corporation understands that for those with asthma, particularly children, choosing the device that best delivers their medication is an important consideration. Research has shown that even when using the same metered-dose inhaler (MDI), not all valved holding chambers perform equally well.[1]

A landmark real-world study involving more than 18,000 asthma patients has demonstrated superior asthma control with the AEROCHAMBER PLUS® FLOW-VU® antistatic Valved Holding Chamber (VHC) compared with other chamber devices.[2] According to the study, published in Pulmonary Therapy, use of the AEROCHAMBER PLUS® FLOW-VU® antistatic chamber resulted in delayed time to first exacerbation, fewer asthma-related emergency department visits, and lower exacerbation-related costs than control chambers.

Asthma is a common respiratory condition that affects an estimated 24.6 million people in the United States. Almost half of them, including nearly 3 million children, experience one or more asthma attack in a year.[3]

As opposed to systemic medications, inhalation is the recommended way to administer asthma medications because it directly targets the drug to the lungs while reducing potential side effects. Inhaled corticosteroids and bronchodilators administered by MDIs are the mainstay of long-term asthma treatment, the goals of which are to improve symptoms and prevent the occurrence of exacerbations.[4]

Poor inhaler operation by users is common, resulting in less of the delivered drug reaching the lungs. Instead, much of it is deposited on the back of the throat (oropharyngeal deposition) and then swallowed.[5] Research shows that between 28% and 68% of patients do not use inhalers well enough to benefit from prescribed medication.[6] In addition, 25% of costs associated with inhalers is wasted due to poor inhaler technique.[6]

Chambers are designed to reduce oropharyngeal deposition by changing the particle size distribution of the inhaled aerosol, and by holding the aerosol in the chamber until the patient is ready to inhale, which reduces the need for good coordination between inhalation and inhaler actuation.[7] Effectiveness of these devices can be adversely affected by the design, including the chamber electrostatic charge, a commonly reported cause of inconsistent medication delivery.[8]

Global respiratory guidelines recommend the use of chambers to improve MDI drug delivery.[4] American Thoracic Society and American Association for Respiratory Care Clinical Practice Guidelines state that the addition of a chamber is recommended and helpful.[9,10] Research also indicates that patients who use a chamber with an MDI have better asthma control than those using an MDI alone.[11]

In this new study, Dr. Chakkarin Burudpakdee (QuintilesIMS, Fairfax, VA, USA) and colleagues compared the effects of the antistatic AEROCHAMBER PLUS® FLOW-VU® aVHC and control chambers on treatment outcomes, resource use, and healthcare costs in a real-world asthma population.[2] More than 18,000 patients were included from an adjudicated claims database containing medical and pharmacy claims for more than 150 million U.S. health plan members.[2]

The analysis showed that among patients with at least 30 days of follow-up, those using the AEROCHAMBER PLUS® FLOW-VU® antistatic VHC experienced a delay in the time to first exacerbation and had fewer asthma-related emergency room visits. In addition, exacerbation-related costs were lower when compared to those using the control (non-antistatic) chambers.[2] A trend toward lower exacerbation rates per patient for the AEROCHAMBER PLUS® FLOW-VU® aVHC was sustained throughout the 12 months of the study.[2]

“This landmark study using a large volume of real-world evidence generated from thousands of patients shows the value of optimizing drug delivery in asthma management and further supports that chambers are not interchangeable,” said co-author Dominic Coppolo, MBA, RRT, FAARC, Vice President Clinical Strategy and Development. “The reduction in exacerbation incidents among users of the AEROCHAMBER PLUS® FLOW-VU® chamber is particularly notable because experiencing an exacerbation is a risk factor for future exacerbation events-and minimizing exacerbation risk is a key goal of treatment.”

“The European Medicines Agency recommended in 2009 that development of a MDI should include the testing of at least one specific, named chamber, and that any substitution must be supported by appropriate in vitro or clinical data demonstrating equivalence,” he said. “We presented laboratory data at the recent Respiratory Drug Delivery Europe meeting[2] that confirmed that not all chambers perform equally well with the same MDI, which underlines the importance of recognizing the impact and potential risks of substituting one device for another.”

About Monaghan Medical Corporation
Monaghan Medical Corporation (MMC) offers leading aerosol drug delivery devices and respiratory management products including AeroEclipse® II BAN, AeroChamber Plus® aVHC and the Aerobika® device exclusively in the United States. MMC’s strength lies in product development around core capabilities in mechanical design complimented by collaboration with a state-of-the-art aerosol research laboratory. MMC focuses on developing cost-efficient, outcome-based solutions for its customers. (http://www.monaghanmed.com)

About AEROCHAMBER® brand valved holding chambers, including the AEROCHAMBER PLUS® FLOW-VU® anti-static chamber
Developed in 1983 to address the needs of asthma and COPD patients having difficulty in taking their MDI medications correctly, the AEROCHAMBER® brand of chamber has innovated continuously to improve patient ease of use and quality of life as well as clinical outcomes and healthcare system savings.

• The AEROCHAMBER PLUS® valved holding chamber is the leading global chamber brand, with safety and efficacy validated in numerous third-party clinical evaluations among various patient populations. It is the chamber most recommended by leading MDI pharmaceutical companies.
• AEROCHAMBER PLUS® FLOW-VU® chamber is an antistatic chamber designed to deliver the intended prescribed dose via the MDI, similar to using an MDI with perfect technique. An additional feature is the incorporation of the FLOW-VU® inhalation indicator for the caregiver to observe effective inhalation. A recent study showed that caregiver quality of life improved almost four-fold when using the AEROCHAMBER PLUS® chamber with FLOW-VU® indicator versus the same chamber without the indicator.[12] The FLOW-VU® indicator provides real-time feedback confirming an effective inhalation and that there are no leakages of ambient air into the space between facemask and face, which could prevent medication delivery altogether. (http://www.monaghanmed.com/AeroChamber-Plus-Flow-Vu-aVHC2)

About the study
Data for more than 18,000 patients with an asthma diagnosis were analysed from the QuintilesIMS Real-World Data Adjudicated Claims Database (PharMetrics Plus) between 1/2010 and 8/2015-9,325 using the AEROCHAMBER PLUS® FLOW-VU® antistatic VHC and a propensity-matched comparison cohort of 9,325 non-antistatic VHCs. Exacerbation incident rates (IR), time to first exacerbation using Kaplan-Meier survival analysis, occurrence of exacerbations, and healthcare resource use and costs were compared.

• Exacerbation IR/100 person-days (95% CI) was significantly higher in the control device cohort than the antistatic chamber cohort (0.161 [0.150-0.172] vs.0.137 [0.128-0.147]); more patients in the antistatic chamber cohort remained exacerbation free.
• 4,293 patients in each cohort were followed up for (greater than or equal to)12 months, during which there was a trend for patients in the antistatic VHC group to be less likely (10-12%) to experience an exacerbation. Fewer patients using the antistatic VHC had an ED visit compared with those in the control group (10.8% vs. 12.4%).
• Exacerbation-related costs for the antistatic VHC cohort were 23%, 25%, 20%, and 12% lower than the control device cohort at 1, 6, 9, and 12 months, respectively.

For clinical inquiries, please contact:
Dominic P. Coppolo, MBA, RRT, FAARC
Vice President Clinical Strategy and Development
Monaghan Medical Corporation
1-800-343-9071

Words or phrases accompanied by ® are trademarks and registered trademarks of Monaghan Medical Corporation or an affiliate of Monaghan Medical Corporation. © 2017 Monaghan Medical Corporation.

References

1 Nagel MW, Suggett JA. Equivalence evaluation of valved holding chambers (VHCs) with albuterol pressurized metered dose inhaler (pMDI). Respiratory Drug Delivery Europe; April 25-28, 2017, 2017; Nice, France.

2 Burudpakdee C, Kushnarev V, Coppolo D, Suggett J. A retrospective study of the effectiveness of the AeroChamber Plus® Flow-Vu® Antistatic Valved Holding Chamber for asthma control. Pulmonary Therapy. 2017. http://doi.org/10.1007/s41030-017-0047-1. Accessed July 14.

3 Asthma Facts. United States Environmental Protection Agency. EPA-402-F-04-019. May 2017.

4 Global Initiative for Asthma: Global strategy for asthma management and prevention, 2017. Available from: http://ginasthma.org/2017-gina-report-global-strategy-for-asthma-management-and-prevention Accessed November 2017.

5 Price D, Bosnic-Anticevich S, Briggs A, et al. Inhaler competence in asthma: common errors, barriers to use and recommended solutions. Respiratory Medicine. 2013;107(1):37-46.

6 Fink JB, Rubin BK. Problems with Inhaler Use: A Call for Improved Clinician and Patient Education. Respir Care 2005;50(10):1360-74.

7 Lavorini F, Fontana GA. Targeting drugs to the airways: The role of spacer devices. Expert opinion on drug delivery. 2009;6(1):91-102.

8 Mitchell JP, Coppolo DP, Nagel MW. Electrostatics and inhaled medications: influence on delivery via pressurized metered-dose inhalers and add-on devices. Respiratory care. 2007;52(3):283-300.

9 Chung KF, et al. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. European Respiratory Journal 2014 ;43:343-373.

10 Ari A, et al. Aerosol Delivery Device Selection for Spontaneously Breathing Patients:2012. Respir Care 2012;57(4):613- 626.

11 Levy ML, et al. Asthma patients’ inability to use a pressurized metered-dose inhaler (pMDI) correctly correlates with poor asthma control as defined by the Global Initiative for Asthma (GINA) strategy: a retrospective analysis. Prim Care Respir J. 2013; Dec;22(4):406-11.

12 Ammari WG, et al. Evaluation of asthma control, parents’ quality of life and preference between AeroChamber Plus and AeroChamber Plus Flow-Vu spacers in young children with asthma. J Asthma 2015; 52(3):301-7.

FED Publishing Releases New Book, “My Journey, A Victory Over Cancer Through Alternative Methods” by Valarie Hendriks

My Journey, A Victory Over Cancer Through Alternative Methods, by Valarie Hendriks, is a story about one courageous woman’s journey and victory over cancer through alternative methods.

Oakland Township, MI, USA — Valarie Hendriks’ My Journey, A Victory Over Cancer Through Alternative Methods is a book that will make you laugh, make you cry, inspire you and motivate you. However, most of all it will help you in battling one of the most dreaded diseases plaguing mankind, cancer.

Valarie Hendriks grew up in the Midwest part of the United States. After college she got a job in the Optical field and is currently working as a Manager and ABO Certified Optician. Along the way she got married to her spouse of twenty five years. Her hobbies are tennis, horseback riding and Ball Room Dancing. She competed in Ball Room Dancing and won several competitions over her career. Then one day she was diagnosed with cancer. At this point in her life she thought her entire world was falling apart. However, she was determined to defeat this dreaded disease.

Her book My Journey, A Victory Over Cancer Through Alternative Methods is a book that Valarie wrote that outlines how she beat cancer. In her book she provides all of the information that she learned through two years of research so that she could help other people in their battle against cancer without going through the trauma of traditional cancer treatments. Her book is uplifting, inspiring, and motivational. It will make you laugh and it will make you cry but most of all it could help you to defeat one of the most dreaded diseases in the world, the disease that we call cancer.

Genre – Cancer, Cure, Alternative Methods, Alternative Medicine, Cancer Cure, Inspiration, Treatment, Motivational

The ebook version of My Journey, A Victory Over Cancer Through Alternative Methods ISBN 9781506903477, published by First Edition Design Publishing (http://www.firsteditiondesignpublishing.com), is available on-line wherever ebooks are sold. The 194 page print book version, ISBN 9781506903460, and ISBN 9781506903453 hardback, are published by First Edition Design Publishing and distributed worldwide to online booksellers.

Media Contact:
Valarie Hendriks
+1(941)921-2607
monty-nbf@att.net

Significant Cost Reduction in COPD Care With Simple, Drug-free Device

Aerobika® OPEP device proves to be a cost-effective treatment option in the management of post-exacerbation COPD patients.

Plattsburgh, NY, USA — The Aerobika® Oscillating Positive Expiratory Pressure (OPEP) device (Monaghan Medical Corporation) is a cost-effective treatment option in the management of COPD exacerbations, according to a study published October 20th in the International Journal of COPD.[1] This study, which used data from the published literature and national fee schedules to model the cost-effectiveness of the Aerobika® OPEP device, shows that it provides both clinical benefit and direct medical cost savings in a post-exacerbation care COPD population.

COPD is a major (and growing) source of morbidity, mortality and healthcare utilization, with hospitalization for acute exacerbations being the biggest cost driver.[2] Once a patient experiences an exacerbation, the risk of further exacerbation is increased two- to four-fold[3], and many patients experience two or three exacerbations every year.[4] As many as one in five patients discharged from hospital following an exacerbation are re-admitted within 30 days.[5]

The economic burden on the healthcare system associated with COPD is significant; in the US alone, the cost of COPD in 2010 was estimated to be US $50 billion; $30 billion in direct healthcare expenditure, with the remainder accounted for by indirect costs such as productivity losses and costs to families.[6] Approximately half of the direct costs could be accounted for by hospital care for COPD exacerbations,[6] which supports the GOLD guideline treatment goals of minimizing the negative impact of exacerbations and preventing recurrences.[2] Healthcare systems in many countries acknowledge the problem, and policies are now being put in place to try to address it; the US Medicare Hospital Readmission Reduction Program penalizes hospitals for excess 30-day, all-cause readmissions after a hospitalization for an acute exacerbation of COPD.[7]

The Aerobika® OPEP device is a drug-free, handheld mechanical oscillating positive expiratory pressure (OPEP) device that has been designed to address the structural and functional challenges in the airways of patients with COPD. When the patient exhales through the device, it helps to expand the airways, loosen and expel mucus from the lungs and may also enhance drug deposition. It has been shown to improve lung function, exercise capacity and quality of life in COPD patients,[8] and a recent real-word study showed that the device reduced exacerbation rates in patients during the critical 30-day post-exacerbation period.[9] Using data from the latter study to provide real-world input, the authors of this current analysis showed cost savings ($553 per patient) and improved outcomes (equivalent to 6 fewer exacerbations per 100 patients per year) with the Aerobika® OPEP device compared with no OPEP/PEP use, and concluded that the device provides cost-effective treatment for post-exacerbation COPD patients.

The authors also used various scenarios to investigate the likelihood of the benefit continuing over a full year, and predicted further clinical and cost benefits (21 exacerbations per 100 patients per year; cost savings of $1,952 per patient). Author Dominic Coppolo, MBA, RRT, FAARC, Vice President Clinical Strategy and Development noted, “Our model provides evidence of clinical and cost benefits of the Aerobika® OPEP device in that critical 30-day period following an exacerbation. Given the high burden of COPD – in particular, costs relating to exacerbations – in the US population, we would expect that even a small benefit would have a significant impact on the healthcare system”. He went on to say that, although further studies would be needed to validate the long-term effectiveness, these data also give a good indication that the benefits will be sustained with long-term use.

“With the increasing pressure to improve care and reduce hospital admissions, the previously-published real-world study showing exacerbation reductions in the critical 30-day post exacerbation period gave us useful insights into the benefits of integrating the Aerobika® OPEP device into standard clinical practice”, noted Dr Jason Suggett (Group Director of Global Science and Technology, TMI). “This new analysis now gives us clear evidence that such clinical benefits would be translated into cost-effectiveness in this post-exacerbation population. In addition, new data presented at CHEST 2017 demonstrating that the generation of the proprietary pressure/oscillation pattern of the Aerobika* device efficiently generates oscillations throughout a high percentage of each exhaled breath, and with consistently high pressure amplitudes. The Aerobika* device demonstrated efficient and effective performance related to therapeutic effectiveness nearly twice that of other devices tested.”[10]

About Monaghan Medical Corporation (MMC, USA)
MMC offers leading aerosol drug delivery devices and respiratory management products including AeroEclipse® II BAN, AeroChamber Plus® aVHC and the Aerobika® device (http://www.monaghanmed.com/aerobika) exclusively in the United States. MMC’s strength lies in product development around core capabilities in mechanical design complimented by collaboration with a state-of-the-art aerosol research laboratory. MMC focuses on developing cost-efficient, outcome-based solutions for its customers.

About the Aerobika® device
The Aerobika® OPEP device (http://www.monaghanmed.com/Aerobika-OPEP) is a hand-held, robust, easy-to-use, drug-free oscillating positive expiratory pressure (OPEP) device designed to help expel mucus from the lungs, expand airways and enhance drug deposition. When the patient exhales through the device, intermittent resistance creates a unique pressure-oscillation dynamic, which expands the airways, helps expel the mucus to the upper airways where it can be coughed out. The Aerobika® OPEP device is designed to function independent of angle of use or flow rate, and allows for a direct aerosol pathway for patients using a nebulizer for medication delivery. The Aerobika® OPEP device has been shown to significantly improve forced vital capacity (FVC), 6-min walk distance (6MWD), and St. George’s Respiratory Questionnaire (SGRQ) score in COPD patients.[8] The Aerobika® OPEP device is available in the US via Monaghan Medical Corporation (http://www.monaghanmed.com), and in Canada, Mexico, and select European countries including the UK and Germany through Trudell Medical International (http://www.trudellmed.com).

About the study
A one-year Markov model was used to estimate the cost-effectiveness of the Aerobika® OPEP device in patients who had experienced an exacerbation in the previous month, or a post-exacerbation care population, with input data from the published literature and national fee schedules. Using a base-case assumption that the benefit of the Aerobika® OPEP device would last 30 days, cost-savings ($553 per patient) and improved outcomes (ie, 6 fewer exacerbations per 100 patients per year) were demonstrated when compared with no OPEP/positive expiratory pressure use. Assuming a scenario with effect beyond the conservative 30 day time frame, the Aerobika® OPEP device continued to show benefit (21 exacerbations per 100 patients per year; cost savings of $1,952 per patient). One-way sensitivity analyses were conducted for all input variables, increasing or decreasing the effect by 20%, to determine the impact of change on costs and health effects; the results supported the robustness of the base-case conclusions.

For clinical inquiries, please contact:
Dominic P. Coppolo, MBA, RRT, FAARC
Vice President Clinical Strategy and Development
Monaghan Medical Corporation
1-800-343-9071

Words or phrases accompanied by ® are trademarks and registered trademarks of Monaghan Medical Corporation or an affiliate of Monaghan Medical Corporation. © 2017 Monaghan Medical Corporation.

1. Khoudigian S, Kowal S, Suggett J, D. C. Cost-effectiveness of the Aerobika* oscillating positive expiratory pressure device in the management of COPD exacerbations. International journal of chronic obstructive pulmonary disease. 2017;In Press.
2. Global strategy for the diagnosis, management and prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2017.
3. Khakban A, Sin DD, FitzGerald JM, et al. The Projected Epidemic of Chronic Obstructive Pulmonary Disease Hospitalizations over the Next 15 Years. A Population-based Perspective. Am J Respir Crit Care Med. 2017;195(3):287-291.
4. Puhan MA, Chandra D, Mosenifar Z, et al. The minimal important difference of exercise tests in severe COPD. Eur Respir J. 2011;37(4):784-790.
5. Guerrero M, Crisafulli E, Liapikou A, et al. Readmission for Acute Exacerbation within 30 Days of Discharge Is Associated with a Subsequent Progressive Increase in Mortality Risk in COPD Patients: A Long-Term Observational Study. PLoS One. 2016;11(3):e0150737.
6. Guarascio AJ, Ray SM, Finch CK, Self TH. The clinical and economic burden of chronic obstructive pulmonary disease in the USA. Clinicoecon Outcomes Res. 2013;5:235-245.
7. Shah T, Press VG, Huisingh-Scheetz M, White SR. COPD Readmissions: Addressing COPD in the Era of Value-based Health Care. Chest. 2016;150(4):916-926.
8. Svenningsen S, Paulin GA, Sheikh K, et al. Oscillatory Positive Expiratory Pressure in Chronic Obstructive Pulmonary Disease. COPD. 2016;13(1):66-74.
9. Burudpakdee C, Seetasith A, Dunne P, et al. A real-world study of 30-day exacerbation outcomes in chronic obstructive pulmonary disease (COPD) patient managed with Aerobika OPEP. Pulmonary Therapeutics. 2017.
10. Meyer A and Suggett J. A Laboratory Assessment into the Efficiency and Effectiveness of Different Oscillating Positive Expiratory Pressure Devices by Means of Patient Simulated Expiratory Waveforms. Presented at CHEST 2017.

Monaghan Medical Corporation Receives Innovative Technology Designation from Vizient for the AEROBIKA® OPEP device

Designation recognizes products that bring improvements to the health care industry.

Plattsburgh, NY, USA — Monaghan Medical Corporation announced its AEROBIKA® Oscillating Positive Expiratory Pressure (OPEP) device has received a 2017 Innovative Technology designation from Vizient, Inc., the largest member-driven health care performance improvement company in the country. The designation was based on direct feedback from hospital experts who interacted with the AEROBIKA® OPEP device at the Vizient Innovative Technology Exchange in Denver on Sept. 14, 2017.

The AEROBIKA® OPEP device is a drug-free, handheld mechanical oscillating positive expiratory pressure (OPEP) device that has been designed to address the structural and functional challenges in the airways of patients with COPD. When the patient exhales through the device, it helps to expand the airways, loosen and expel mucus from the lungs and may also enhance drug deposition. It has been shown to improve lung function, exercise capacity and quality of life in COPD patients,1 and a real-world study showed that the device reduced exacerbation rates in patients during the critical 30-day post-exacerbation period.2 These improved outcomes (equivalent to 6 fewer exacerbations per 100 patients per year) equate to a cost savings of $553 per patient with the AEROBIKA® OPEP device compared with no OPEP/PEP use, making the device a cost-effective treatment for COPD patients.

“We are extremely pleased to have been awarded this prestigious recognition from Vizient,” said Dominic Coppolo, MBA, RRT, FAARC, Vice President Clinical Strategy and Development. “Our device was recommended by Vizient members, which is a validation of all of the design and clinical work we have done to support our customers. We are the only OPEP device to have received this designation at this year’s Innovative Technology Exchange, and are proud it was recognized to deliver improved outcomes and enhanced safety.”

“Based on feedback from attendees at the Vizient Innovative Technology Exchange, it was determined that the AEROBIKA® OPEP device should be recognized with an Innovative Technology designation. This designation will be noted in our online member contract catalog. Congratulations to Monaghan Medical Corporation on receiving this status,” said Debbie Archer, director of procurement and Vizient Innovative Technology Program lead.

Vizient represents a diverse membership base that includes academic medical centers, pediatric facilities, community hospitals, integrated health delivery networks and non-acute health care providers and represents more than $100 billion in annual purchasing volume. Through its Innovative Technology Program, Vizient works with member-led councils and task forces to review potentially innovative products. If it is determined that a product is innovative, Vizient may award a contract outside of the competitive bid cycle.

About Monaghan Medical Corporation (MMC, USA)
MMC offers leading aerosol drug delivery devices and respiratory management products including AeroEclipse® II BAN, AeroChamber Plus® aVHC and the Aerobika® device exclusively, directly and through distributors, in the United States. MMC’s strength lies in its commitment to product quality, outcome based solutions for customers, and its collaboration with a state-of-the-art aerosol research laboratory. (http://www.monaghanmed.com)

1. Svenningsen S, Paulin GA, Sheikh K, et al. Oscillatory Positive Expiratory Pressure in Chronic Obstructive Pulmonary Disease. COPD. 2016;13(1):66-74.
2. Burudpakdee C, Seetasith A, Dunne P, et al. A real-world study of 30-day exacerbation outcomes in chronic obstructive pulmonary disease (COPD) patient managed with Aerobika OPEP. Pulmonary Therapeutics. 2017.

For clinical inquiries, please contact:
Dominic P. Coppolo, MBA, RRT, FAARC
Vice President Clinical Strategy and Development
Monaghan Medical Corporation
1-800-343-9071

Stanford University Trial Demonstrates Accuracy of Accuro Automated Ultrasound

Anesthesia & Analgesia Publishes Results of RIVANNA’s Image-Guided Technology’s Epidural Success.

Charlottesville, VA, USA — A clinical trial conducted at Stanford University Medical Center published this week in Anesthesia & Analgesia* proved the accuracy of the Accuro® image-guided spinal navigation system in calculating the optimal site and needle depth for epidural anesthesia administration. The research is the latest in a series of studies supporting the efficacy of RIVANNA‘s handheld ultrasound system with proprietary pattern recognition software, which identifies spinal landmarks and provides automated epidural placement guidance. The innovative Accuro platform also has application in a range of additional medical procedures that benefit from visualization of targeted anatomical areas.

In the trial, RIVANNA® Accuro identified the appropriate epidural injection sites along the lower spine and calculated the depth to the epidural space, a narrow hollow area in the spine. Actual epidural depth was confirmed by measuring needle penetration during successful epidural delivery by anesthesia providers. Accuro predicted this depth within an average of .61 cm.

In addition, Accuro identified the appropriate spinal interspace for needle insertion in 94% of patients and enabled 87% success in first-attempt epidural administration. The research was conducted under the direction of Brendan Carvalho, MD, at Stanford Medical Center and led by Katherine Seligman, MD, currently faculty at the University of New Mexico.

“The ability to visualize spinal anatomy in detail during epidural needle placement has a strong impact on the procedure’s success,” says Will Mauldin, Chairman and CEO of Rivanna Medical. “Today, anesthesiologists rely on spinal palpation and their knowledge of spinal anatomy to determine the appropriate injection site and depth. Depending on the patient condition and physician skill, up to 80% of first attempt epidural needle placements fail. Obesity and atypical spinal characteristics such as scoliosis place patients significantly at failure risk.”

Repeated epidural needle insertions can negatively impact the patient with ongoing headaches, bleeding, back pain and possibly paralysis. Failed epidurals cost the medical system more than $1.5 billion annually.

Mauldin notes that ultrasound is the imaging modality of choice for epidurals because most are administered to expectant mothers who must avoid the radiation involved in other imaging procedures.

Significant research shows that ultrasound guidance of epidural and other neuraxial anesthesia significantly improves efficacy and patient safety. However, performing and interpreting ultrasound requires specialized training not typically in the anesthesia provider’s skillset.

Accuro’s SpineNav3D™ computerized ultrasound image guidance eliminates the steep ultrasound learning curve, making it simple and practical for anesthesiologists and other medical professionals not trained in the modality.

“This study published in a respected anesthesiology publication underscores the device’s precision in providing physician guidance,” says Mauldin.

In addition to innovative image guidance, RIVANNA Accuro also incorporates BoneEnhance® technology, which optimizes the device for visualization of bony spinal anatomy. Accuro delivers a five- to 10-fold increase in bone-to-tissue contrast compared to traditional ultrasound, which is generally preferred for soft tissue imaging. The pocket-sized, wireless device is simple and practical to use in a wide range of settings where traditional large, unwieldy systems can be a problem.

“Accuro is designed to eliminate the risks of multiple needle placement attempts, increasing patient satisfaction while supporting anesthesiology workflow,” notes Mauldin. “A growing number of studies underscore the device’s success in meeting these goals.”

A recent randomized trial at University of Virginia Medical Center found that for residents with prior spinal anesthesia experience, Accuro improved first-attempt needle placement by more than 100% in patients with a high body mass index. Appropriate needle placement in these patients is particularly difficult. The average number of needle redirections to achieve placement using Accuro was almost half that of the same sub-group using conventional placement methods.

* ANESTHESIA & ANALGESIA is the official journal of the International Anesthesia Research Society.

About Accuro® and Rivanna Medical, LLC
RIVANNA® Accuro is the world’s first ultrasound-guidance system designed to effortlessly enhance spinal and epidural anesthesia placement accuracy. The revolutionary platform features BoneEnhance®, which optimizes ultrasound for the visualization of bony vs. soft tissue anatomy, and SpineNav3D™, which automates measurements of the spinal midline, epidural depth and trajectory. Accuro was engineered and commercialized by RIVANNA, an innovative medical device company headquartered in Charlottesville, VA. The proprietary device is FDA 510(k)-cleared for a variety of imaging applications. For anesthesia providers, certainty can be effortless with Accuro. For more information, visit http://www.rivannamedical.com.

Copyright © by Rivanna Medical, LLC. All rights reserved. RIVANNA® and Accuro® are registered trademarks of Rivanna Medical, LLC.

Media Contact:
HealthFlash Marketing
Jeanne-Marie Phillips, 203-977-3333
jphillips@healthflashmarketing.com

Progressive Bay Area Executive Protection Teams Incorporate Medical Component to Enhance Protection of Their Principals

Bay Area Emergency & EP Professionals to Present, “Emerging Trends in Executive Protection Medical Programs” at ASIS International 2017.

Redwood City, CA, USA — Emergency University, the industry leader in corporate Emergency Response system design, emergency medical training and state-of-the-art response and collaborative technologies announced today that Dr. Odelia Braun, Medical Director of Emergency University, Eric Powell, Chief Security Officer of Bayshore Global Management, and William Killgallon, Head of Security and Crisis Management, GE Digital will lead an Impact session on, “Emerging Trends in Executive Protection Medical Programs” at the upcoming ASIS International Conference at the Kay Bailey Hutchison Convention Center in Dallas on September 26, 2017.

As Executive Protection models evolve, EP professionals are increasingly aware of the importance of integrating medical capabilities into their security protection models to reflect the needs of their principals. The panel will address the critical components to consider when designing EP Medical Programs.

After studying the challenges faced in designing these complex Executive Protection Programs, the panel of EP professionals and experienced emergency physicians developed a standardized process to evaluate the status of their current teams, and set short-term and long-term goals. They designed and implemented a coordinated program of medical protocols, targeted training programs, equipment and technology, designed to orient and prepare security teams to effectively respond to medical issues while ensuring that the solutions emphasized security first.

“Medical capability in the executive/dignitary protection arena is a critical resource. Having medical care on hand dramatically increases the probability of mission success,” Killgallon remarked. “For example, one of the primary reasons the murder rate has decreased in the last 30 years in the US is not because of less violence – there is actually more – or better law enforcement; it is because of better, faster, and closer emergency medical care – people are surviving things that used to kill them.”

A well-prepared medical program ensures the best clinical outcome for protectees experiencing medical emergencies. The presenters will emphasize due diligence, ways to minimize risk and assemble vital components into a cohesive system that predictably achieves effective medical protection.

About Emergency University: For more than 20 years, Emergency University has assisted national and global corporations and government agencies in the development of effective internal emergency response system planning and design, provided comprehensive emergency response preparedness training, as well as researched, developed and implemented Executive Protection Medical program solutions with cutting-edge technological support – ensuring their clients are 100% prepared! Emergency University’s clients enjoy an outstanding 100% response rate versus the national average of 2%. EU’s educational methodology prepares students to respond while offering its clients a one-stop solution for emergency response system design, compliance and training. Additional information on Emergency University is available at: http://www.emergencyuniversity.com.

Media Contact:
T. Farina
Emergency University
866-233-4357
tfarina@emergencyuniversity.com
http://www.emergencyuniversity.com