FDA News

BiPAP AutoSV Device Designed For Complicated Sleep-Disordered Breathing Patients Approved by FDA

(March 07, 2007)--Respironics, said that the FDA granted 510(k) clearance of the BiPAP autoSV device, which is intended to provide noninvasive ventilatory support to treat adult patients with Obstructive Sleep Apnea (OSA) and Respiratory Insufficiency caused by central and/or mixed apneas and periodic breathing.

"We are excited about broadening our product portfolio in the sleep and respiratory markets with the BiPAP autoSV device, which expands our ability to provide life-changing therapy to a wider population of patients," said John L. Miclot, president and CEO of Respironics.

The BiPAP autoSV device was previously launched in Europe and Canada and to date the market acceptance of this product has been very positive. This product is designed for managing complicated sleep-disordered breathing patients and combines a number of Respironics' core technologies to recognize and respond to patients' changing pressure needs.

The BiPAP autoSV device delivers optimal therapy for these complicated sleep-disordered breathing patients utilizing a multi-level algorithm. On a breath-by-breath basis, the revolutionary algorithm utilizes Respironics' core technologies to adjust pressure support upon detecting a sleep event, such as an apnea, hypopnea or periodic breathing, to stabilize the patient's breathing pattern. This algorithm also calculates the patient's spontaneous breathing rate and will automatically trigger a breath for the patient should a sleep event occur. This device also combines Respironics' proven BiPAP technology, Encore(R) Pro Data Management Software, Digital Auto-Trak(TM) Sensitivity, integrated alarms and optional integrated heated humidification. Respironics plans to begin domestic distribution of this product later in the current fiscal year.

Share or bookmarklet this web page at: