Wednesday, October 1, 2008

Teleflex Medical Introduces the Neb-U-Mask for the Treatment of Acute Asthma Exacerbations

(BUSINESS WIRE)--Teleflex Medical, a leading global supplier of disposable products for critical care and surgical applications, has received clearance from the FDA to market the Hudson RCI Neb-U-Mask®, a respiratory device that allows for the concurrent delivery of aerosolized medication and a high concentration of medical gases to treat acute asthma exacerbations.

Asthma is a chronic inflammatory disease of the airways. According to the National Asthma Education and Prevention Program, asthma affects more than 22 million people in the United States, and is one of the most chronic childhood diseases. It is estimated that asthma accounts for approximately 1 in every 250 deaths worldwide. Many of the deaths are preventable. Despite current available therapy with the use of bronchodilators and corticoids, alleviation of obstruction may not occur rapidly enough to prevent ventilatory failure and endotracheal intubation.

During an acute asthma attack, a patient may be given oxygen or heliox in combination with pharmacologic therapies. The challenge of this treatment approach is the lack of a device that allows for the simultaneous delivery of medical gases and aerosolized medication. In a study published in the Annals of Emergency Medicine in 2002, low oxygen saturation has been correlated inversely with the rate of hospitalization1, which puts caregivers in a difficult situation when faced with the choice of medication delivery over an interruption of high levels of oxygen therapy.

The Neb-U-Mask addresses this unmet clinical need by allowing the concurrent delivery of aerosolized medications and high concentrations of oxygen or heliox. The system is composed of an innovative wye design, featuring a nebulizer connection and MDI adaptor, a non-rebreathing mask with a 750ml gas reservoir bag, and color coded tubing. This patented design promotes positive patient outcomes by avoiding therapy interruption. The nebulizer connection features a valved port, which maintains a closed system when a nebulizer is not in use. This closed system design allows for delivery of high levels of oxygen or heliox gas mixtures.

“We are pleased to add the Neb-U-Mask to our extensive line of asthma management solutions,” said Whitney Reynolds, director of respiratory care marketing. “At Teleflex Medical our ultimate goal is to provide products and education programs to help patients with asthma live a normal, healthy, and productive life. But knowing that acute asthma attacks are prevalent, we must provide caregivers the tools they need to achieve positive patient outcomes.”

The system is available for sale today in both adult and pediatric versions. The system is conveniently packaged with a Micro Mist® nebulizer, allowing for a “grab and go” response in an emergency situation.

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