DeVilbiss Healthcare Sponsors Clinical Trial Confirming the Effectiveness of SmartFlex™ Technology

SOMERSET, PA - July 5, 2011 - DeVilbiss Healthcare LLC recently sponsored a randomized, double-blind, crossover clinical study which confirmed the effectiveness of DeVilbiss SmartFlex Technology, a new exhalation pressure relief solution to enhance patient comfort.


Positive Airway Pressure (PAP) represents the gold standard in the treatment of Obstructive Sleep Apnea (OSA).  In recent years, pressure modification has become accepted as an important feature for improving patients' comfort and compliance.  However, there has been some speculation that excessive pressure relief may compromise the effectiveness of therapy.


The study confirmed SmartFlex Technology to be equally effective to standard Auto-PAP therapy in that respiratory events and oxygen saturation during sleep were normalized among the participants.  In addition, treatment with SmartFlex showed a lower leak rate, which likely contributes to the greater subject acceptance rates.  As expected, both modalities resulted in improved daytime alertness, but improved daytime energy levels, ability to relax and nocturnal sleep were also demonstrated with SmartFlex Technology.


The study included 28 patients with a recent diagnosis of OSA who agreed to participate in the research study.  Patients were randomly assigned to Auto-PAP (with or without SmartFlex) for two weeks and were then switched for continued therapy for an additional two weeks.  While all participants experienced treatment with and without SmartFlex, both participants and researchers were blinded to the assignment of SmartFlex.


The study results were presented at the Associated Professional Sleep Society's 2011 Sleep Conference and Exhibition in Minneapolis by the Principal Investigator of the study, Dr. Leon Rosenthal, M.D. of Sleep Medicine Associates of Texas, P.A.


"Patient comfort and acceptance of therapy is critical to establishing an adherent patient," said Mike Marcinek, Vice President of Sales and Marketing - Sleep Solutions at DeVilbiss Healthcare.  "We are very excited to see that there was improvement in sleep, relaxation and lower leak rates while on SmartFlex.  With the objective clinical results appearing to show parity between the two therapies, there is a tremendous amount of subjective data currently being analyzed.  We are excited to review all the findings with the goal of continuing to provide optimal solutions to patients."


DeVilbiss SmartFlex Technology provides three pressure relief drops and six rounding settings to ease inhale and exhale transitions.  The SmartFlex transitions can be adjusted with DeVilbiss' patented Flow Rounding Technology to make the pressure drops and the corresponding increase feel even more natural to each patient.  SmartFlex Technology is available exclusively on the DeVilbiss IntelliPAP® AutoAdjust® and IntelliPAP Standard Plus PAP systems.


Dr. Rosenthal has been involved in the field of Sleep Medicine for over 20 years.  Throughout is career, he has been involved in patient care, education and research.  Dr. Rosenthal's contributions to the field include over 95 publications in Sleep Medicine, Otolaryngology, Psychiatry and Pulmonary Medicine journals and books.  He has served in both the Sleep Research Society (SRS) and the American Academy of Sleep Medicine (AASM) in various roles.  He has been a previous Publications Chair for the SRS and chair of the International Affairs Committee for the AASM.


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