Hill-Rom Receives FDA 510(k) Clearance to Market MetaNeb 4.0 Airway Clearance System
May 06, 2013, 04:00 ET
BATESVILLE, Ind., May 6, 2013 /PRNewswire/ -- Hill-Rom Holdings, Inc. (NYSE: HRC), a global leader in healthcare technologies, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration to market the MetaNeb® 4.0 System, the company's latest advancement in airway clearance technology for enhanced patient care in the hospital. Delivering therapy through airway oscillation (Continuous High Frequency Oscillation) and continuous pressure (Continuous Positive Expiratory Pressure), the MetaNeb 4.0 System helps enhance normal mucus clearance from the lungs, delivers lung expansion therapy, and assists in the treatment and prevention of pulmonary atelectasis, a complete or partial collapse of the lung.
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The system also has the ability to provide supplemental oxygen when used with compressed oxygen. The next-generation MetaNeb 4.0 System improves therapy performance, enhances ease of use when used with mechanical ventilation, and enhances therapy delivery.
"The design enhancements to the MetaNeb System represent another great example of Hill-Rom's dedication to improving outcomes for patients and their caregivers," said Greg Pritchard, Senior Vice President, Surgical and Respiratory Care, for Hill-Rom. "Together with The Vest® Airway Clearance System, our Respiratory Care portfolio now offers complementary innovative solutions for patients with respiratory disorders."
Patients who may benefit from the MetaNeb 4.0 System, which will begin shipping in June, include those with one or more of the following disease states:
- Bronchiolitis
- Cystic Fibrosis
- Asthma
- Chronic Bronchitis
- Neuromuscular Disorders
- Emphysema
- Chronic Obstructive Pulmonary Disease (COPD)
- Patients Needing Post-Operative Airway Management
- Patients Needing Emergency Room Airway Management
ABOUT HILL-ROM HOLDINGS, INC.
Hill-Rom is a leading worldwide manufacturer and provider of medical technologies and related services for the health care industry, including patient support systems, safe mobility and handling solutions, non-invasive therapeutic products for a variety of acute and chronic medical conditions, medical equipment rentals, surgical products, and information technology solutions. Hill-Rom's comprehensive product and service offerings are used by health care providers across the health care continuum and around the world in hospitals, extended care facilities and home care settings to enhance the safety and quality of patient care.
Hill-Rom...enhancing outcomes for patients and their caregivers.
DISCLOSURE REGARDING FORWARD-LOOKING STATEMENTS
Certain statements in this press release contain forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, regarding the Company's future plans, objectives, beliefs, expectations, representations and projections. The Company has tried, wherever possible, to identify these forward-looking statements using words such as "intend," "anticipate," "believe," "plan," "encourage," "expect," "may," "goal," "become," "pursue," "estimate," "strategy," "will," "projection," "forecast," "continue," "accelerate," "promise," "increase," "higher," "lower," "reduce," "improve," "expand," "progress," "potential" or the negative of those terms or other variations of them or by comparable terminology. The absence of such terms, however, does not mean that the statement is not forward-looking. It is important to note that forward-looking statements are not guarantees of future performance, and the Company's actual results could differ materially from those set forth in any forward-looking statements. Factors that could cause actual results to differ from forward-looking statements include but are not limited to: the Company's dependence on its relationships with several large group purchasing organizations, whether the Company's new products are successful in the marketplace, impacts of healthcare reform, compliance with federal healthcare programs, collections of accounts receivable, compliance with FDA regulations, potential exposure to product liability or other claims, failure of the Company's announced or future strategic initiatives and restructuring and realignment activities to achieve expected growth, efficiencies or cost reductions, failure of the Company to execute its acquisition and business alliance strategy through the consummation and successful integration of acquisitions or entry into joint ventures or other business alliances, increased costs or unavailability of raw materials, adverse changes in global economic conditions or disruptions of credit markets, labor disruptions, the ability to retain executive officers and other key personnel, and certain tax-related matters. For a more in depth discussion of these and other factors that could cause actual results to differ from those contained in forward-looking statements, see the discussions under the heading "Risk Factors" in the Company's previously filed most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q. The Company assumes no obligation to update or revise any forward-looking statements.
SOURCE Hill-Rom Holdings, Inc.