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As a practicing technologist for the last twelve years I have seen the evolution of nasal CPAP masks. Now, I have witnessed a true revolution in the delivery of PAP pressure. The InnoMed Nasal Aire II is an outstanding example of comfort and convenience. As a technologist I know the importance of a good interface seal for the proper maintenance of the upper airway, but as a CPAP user for the past 2 years, I also realize the importance of comfort and ease of use. I struggled with compliance, searching tirelessly for a comfortable interface that would allow me to sleep in multiple positions without leaking or causing discomfort. Mask after mask fell short. Some masks left my nose red and irritated while the headgear caused headaches. The Nasal Aire II is truly easy to wear and very comfortable to sleep with. It affords me a free range of motion and sleeping positions. Also, the stabilizing headgear is soft and versatile, allowing for customized fitment configurations. The Nasal Aire II has made it easy for me to become compliant and stay compliant. I would recommend anyone on PAP treatment give the Nasal Aire II a try. Sincerely,
Brazell H. Carter M.D., Inc To Whom It May Concern: Sincerely,
Kenneth Rotskoff, MD, DDS I have seen Nasal Aire sleep apnea device for the treatment of sleep apnea and I have been involved in the development of the patient information for using this device. I am pleased to see the Nasal Aire interface finally available for sleep apnea patients. I feel that the Nasal Aire interface will significantly increase patient compliance, comfort, and result in improved treatment for those who require C-pap for the treatment of sleep apnea. In my professional opinion, I feel that patients will greatly benefit from the use of the Nasal Aire and benefit from its technology. Sincerely,
Robert D. Coli, M.D., F.A.C.P., F.A.C.G. Pulmonary medicine specialists in Rhode Island who have seen and are starting to use the Nasal Aire interface already describe it to me as a major breakthrough for almost all of their patients with obstructive sleep apnea. Compared to all existing interfaces used in the medical treatment of this intractable chronic condition, I believe that this lightweight and very comfortable device is a groundbreaking innovation that will be welcomed by the great majority of patients with obstructive sleep apnea, chronic obstructive pulmonary disease and even the approximately 35% of congestive heart failure (CHF) patients with obstructive sleep apnea, a rate that is six to seven times higher than that seen in the general population. Compared to face mask-based CPAP and BIPAP devices, "nasal pillows" and customized mouth retainers costing $800 or more, the design of the Nasal Aire device significantly improves patient compliance and can positively influence clinical outcomes. Because of its efficacy and cost-effectiveness, I believe it will also be welcomed by third party payers who must supply durably medical equipment to their members. I would be happy to provide additional clinical details at any convenient time. Sincerely,
Paul A. Tucker, M.D. This fall we used the Nasal Aire device on a patient of mine with severe obstructive sleep apnea, biventricular congestive heart failure, and morbid obesity. This patient was previously noncompliant with previous CPAP devices, and required multiple hospitalizations. To date, the Nasal Aire device has made a significant impact on his overall health, with improvement in his sleep apnea episodes, and has made his heart failure easier to control. His compliance is significantly greater. This is a great product! Sincerely,
Juan Cevallos. M.D. FCCP It is with great interest that I read the bulletin. I am now one of the most emphatic believers in this new interface. I run two sleep labs in this area, and continuously change patients to the Nasal Aire. My skepticism has vanished and I even use it for high pressure BIPAP of 20/16! The patients love it. The potential for this interface is enormous. I will be going to Madrid, Spain in November. Would you put me in contact with your European sales team? I would love to share our experience with some members of the sleep community in Spain. I am on your advisory board. Sincerely,
Testimonials from Patients May 3, 2002 April 26, 2002 I am one of the few individuals selected to participate in your trial studies for FDA approval of your revolutionary "Nasal-Aire" headgear (ventilation devices) for sleep apnea patients. I am extremely claustrophobic and could not, would not, tolerate the traditional mask that is confining, loud, and uncomfortable. When I was initially diagnosed with Apnea in Fall 2001, I was blessed to have the talents of the Nevada State Respiratory team. They were one of your providers involved in the initial trails. They provided me with one of your prototypes of the "Nasal-Aire" to wear during my testing and subsequently for therapy. Without your device, I would have failed. Your device is comfortable. I have no feelings of claustrophobia and within minutes, tolerated the device. I've used it for the last 7 months awaiting FDA approval of your product. It was beginning to wear from the extreme use. I began to panic at the thought of wearing the traditional mask apparatus resembling an alien costume. I continued to call NV State Respiratory to see when your new product would go on sale--they deserve an award for their patience and continued attempts to find me a replacement for my aging "Nasal-Aire." Yesterday, 4-25-02, I was able to purchase your first release of the FDA approved product. You've made some great improvements to include the Velcro strap for comfort. As before, it works perfectly. Your company name is most appropriate because your are innovative. Your invention will ease the suffering of millions coping with sleep apnea and provide restful, unhindered rest. My sincere thanks, April 18, 2002 I have found the new Nasal-Aire mask has given me a new feeling of freedom. Free of a hard plastic shell. Free of the weight of gel masks. Free of headgear that somehow coaxes your hair to find unusual way to lay. Free to read, watch TV. Free of daily strap marks on your skin. Free of moisture collecting on a warm evening under a mask. The mask is comfortable, delivers the prescribed pressure. It has not caused sore spots in the nares. This is an exciting new way to comfortably treat sleep apnea. Sincerely,
September 12, 2006
I have been a thankful wearer of the
InnoMed breathing headgear for years. The new Nasal-Aire Headgear with
OHS Assembly Part No. X2105, to me is a great innovation. The shipment
from the V.A. arrived today. I've been wearing the device for three
hours, to become familiar with it. The improvements are very obvious,
some of the pluses as I see them are: continued use of heavier gauge
tubing, wide and slightly thicker Velcro, the addition of larger loops
for the tube holders, seems like new device to hold tubes under the
neck.
Starting with Dr. Goldstein of Boca
Raton, FL, his diagnosis of my sleep apnea, the state-of-the-art
breathing machines, and InnoMed's headgear my life has been forever
changed. No longer do I wake exhausted, my wife after 30 years of
sleepless nights now sleeps well, the threat of a possibility of heart
failure during the night is considerably reduced. I sincerely thank
the people and companies involved in the ongoing research. You are
helping millions of people.
B.H.K.
Tamarac, Florida
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