Monaghan Medical Corporation Announces FDA Clearance for New Respiratory Treatment Option

January 07 16:15 2020
Simple-to-use, cost-effective devices provide tandem therapy for lung expansion and airway clearance.

Plattsburgh, NY, USA – Monaghan Medical Corporation (MMC) today announced the newly approved combination for two of its groundbreaking products – the Aerobika® oscillatory positive expiratory pressure (OPEP) device and the VersaPAP® positive airway pressure device-to create a low cost, safe and effective “tandem therapy” which allows clinicians to treat a variety of pulmonary conditions requiring lung expansion and airway clearance.

Lung expansion therapy is designed to prevent or treat atelectasis-the complete or partial collapse of the lungs-and can also reduce air trapping on exhalation caused by conditions such as asthma or chronic obstructive pulmonary disease (COPD). The overall goal of this tandem therapy is to improve lung volumes by maximizing lung re-expansion (alveolar recruitment) while optimizing airway clearance.

About Tandem Therapy

The combination of Aerobika® OPEP and VersaPAP® devices allows for an efficient and effective synergy when used in tandem, optimizing the function of each.

Augmentation of maximum flow from the VersaPAP® device creates airway expansion on inhalation, allowing for the patient to take in a larger breath. This, in turn, means the patient will have more air to exhale. Oscillations from the Aerobika® OPEP device are then maximized on exhalation to improve airway clearance and further lung expansion by the added resistance of both devices. This results in patients receiving positive pressure on inhalation and exhalation, simultaneously optimizing lung expansion and airway clearance.

Tandem therapy is yet another added value to a complete system of care for respiratory ailments. The Aerobika® OPEP, VersaPAP® device, and AeroEclipse® II Breath Actuated Nebulizer (BAN) can be used individually or in a variety of combinations to efficiently and effectively treat a patient’s pulmonary condition, and easily adjust therapeutic regimens as a patient’s condition changes.

This “plug and play” model is not only cost effective, but also a true benefit to patients in a hospital setting and as they transfer to a residential setting.

For clinical inquiries, please contact:

Dominic P. Coppolo, MBA, RRT, FAARC
Vice President Clinical Strategy and Development
Monaghan Medical Corporation
1-800-343-9071

About the Aerobika® OPEP Device

Aerobika® OPEP is a hand-held, easy to use, robust, drug-free oscillating positive expiratory pressure device designed to move fluid out of the lungs, expand the airways and enhance delivery of medication by aerosol spray. When a patient exhales through the device, intermittent resistance creates a pressure-oscillation dynamic that expands the airways and mobilizes secretions.

The Aerobika® OPEP device is designed to function regardless of flow rate or the angle in which it is held. It also minimizes drug loss by allowing for a direct aerosol pathway when used in combination with nebulizer therapy.

Clinical and real-world data show that the Aerobika® OPEP device increases lung volumes, reduces hyperinflation and improves airway clearance in patients with COPD(1) or bronchiectasis(2) and reduces exacerbations associated with COPD.(3)

The Aerobika® OPEP device is suitable for use for up to 12 months.

About the VersaPAP® Device

The VersaPAP® device is a hand-held, easy-to-use device that amplifies supplied air by four times to create positive pressure on inhalation, allowing for a larger breath to be drawn in. On exhalation, the additional air creates a slight resistance for the patient which, in turn, expands the airways, improves gas exchange in the lungs and can assist with the mobilization of secretions.

The VersaPAP® device has an integrated manometer that provides immediate feedback to both the patient and the clinician, making it easy to monitor and achieve desired airway pressures. Studies show that the addition of positive airway pressure can help reduce or reverse partial or complete collapse of the lungs.(4)

About Monaghan Medical Corporation (MMC, USA)

Monaghan Medical Corporation focuses on developing cost-efficient, outcome-based solutions for its customers and continues to introduce new products and new product enhancements to support its mission to ensure device quality for patients. MMC’s strength lies in product development around core capabilities in mechanical design complimented by collaboration with a state-of-the-art Global Aerosol and Research Laboratory. (https://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) Svenningsen S, Guo F, McCormack DG, Parraga G. Noncystic Fibrosis Bronchiectasis: Regional Abnormalities and Response to Airway Clearance Therapy Using Pulmonary Functional Magnetic Resonance Imaging. Academic Radiology. 2017;24(1):4-12.
(3) 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.
(4) AARC Clinical Practice Guideline: Use of Positive Airway Pressure Adjuncts to Bronchial Hygiene Therapy. Respir Care 1993;38(5):516- 521.

Words or phrases accompanied by ® are trademarks and registered trademarks of Monaghan Medical Corporation or an affiliate of Monaghan Medical Corporation. © 2019 Monaghan Medical Corporation.

Media Contact
Company Name: Monaghan Medical Corporation
Contact Person: Dominic P. Coppolo
Email: Send Email
Phone: 800-343-9071
Country: United States
Website: http://www.monaghanmed.com