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Press release from PR Newswire

ResMed Noninvasive Ventilation Device Cleared by FDA for COPD Treatment

Thursday, April 25, 2013

ResMed Noninvasive Ventilation Device Cleared by FDA for COPD Treatment

08:00 EDT Thursday, April 25, 2013

First At-Home Ventilation Device Cleared Specifically for COPD Designed to Reduce Hospital Readmissions

SAN DIEGO, April 25, 2013 /PRNewswire/ -- One in five patients with stage 3 or 4 chronic obstructive pulmonary disease (COPD) hospitalized for acute exacerbations are readmitted to the hospital within 30 days, but these readmissions may be avoided with the right at-home therapy, according to ResMed (NYSE: RMD), an innovator and pioneer in developing products for the treatment of sleep-disordered breathing and respiratory conditions.

(Photo: http://photos.prnewswire.com/prnh/20130425/LA01492-a)

(Photo  http://photos.prnewswire.com/prnh/20130425/LA01492-b)

(Logo: http://photos.prnewswire.com/prnh/20100203/RESMEDLOGO)

The Food and Drug Administration (FDA) recently cleared ResMed's home variable positive airway pressure (VPAP) device ? also known as bilevel PAP ? for the treatment of respiratory disorders such as COPD, giving severe COPD sufferers a weapon in the fight to stay out of the hospital. ResMed introduced its VPAP? COPD device today; it will be sold in the U.S. and because of the FDA's clearance for the treatment of COPD, it will make bilevel therapy more accessible through Medicare's Respiratory Assist Device qualifying guidelines.

"Many stage 3 or stage 4 COPD patients are admitted to the hospital two to three times a year because of their condition, and hospital discharge planners need ways to reduce that figure with better at-home respiratory care," said Geoff Neilson, president of ResMed's Respiratory Care business unit. "Minimizing the likelihood of acute events that lead to readmissions starts at the point of discharge, sending patients home with the best tools like ResMed's VPAP COPD to help them breathe better when their lungs have been damaged by the disease."

The ResMed VPAP COPD is used at night, which helps ensure that COPD patients maintain their ventilation when they are most vulnerable. It customizes the breath delivered to the patient with a rapid inhalation phase and allows an extended exhalation. This can help overcome air trapping that is common in COPD patients, enabling better gas exchange in their lungs.

Built on the popular ResMed S9? Series platform, the VPAP COPD device is compact and easy for a patient to integrate into a sleep setting. Combined with the companion H5i? heated humidification device, the VPAP COPD creates a comfortable patient experience, increasing the likelihood of patients continuing their therapy.

ResMed S9 Platform and EasyCare Online Monitoring Provides Total Solution

As part of the total therapy solution, the VPAP COPD device may be wirelessly connected to ResMed's secure, cloud-based EasyCare Online monitoring system. EasyCare Online allows physicians, hospitals and homecare partners to monitor patient use and patient respiratory health on a daily basis. This immediate and automated feedback is critical during the important 30-day post-discharge period, and can help reduce the time and labor hospitals invest in follow-up with these patients, while possibly achieving a better outcome.

ClimateLineMAX? Oxy Tubing Seamlessly Integrates with Oxygen Therapy

ResMed has also created a special ClimateLine? tubing between the humidifier and mask that has an oxygen line port next to the VPAP COPD device. Oxygen therapy can be easily combined with the VPAP COPD and its Climate Control humidification system.

"ClimateLineMAX Oxy gives patients a no-compromise solution with the best bilevel therapy and best humidification, with no condensation, and it connects quickly and easily to their source of oxygen," said Neilson. "ResMed takes advantage of each building block for a positive patient experience, from superior comfort to an attractive and easy-to-use device."

The ResMed VPAP COPD and ClimateLineMAX Oxy tubing with oxygen line input are both available now from ResMed authorized dealers.

About ResMed:ResMed is a global leader in the development, manufacturing and marketing of medical products for the diagnosis, treatment and management of respiratory disorders, with a focus on sleep-disordered breathing. The company is dedicated to developing innovative products to improve the lives of those who suffer from these conditions and to increasing awareness among patients and healthcare professionals of the potentially serious health consequences of untreated sleep-disordered breathing. For more information on ResMed, visit www.resmed.com.

SOURCE ResMed

For further information: Gretchen Griswold, Director, Global Corporate Communications, +1-858-836-6789, news@resmed.com ; Constance Bienfait, Director, Investor Relations, +1-858-836-5971, constance.bienfait@resmed.com

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