Medical Device Daily

Patients who suffer from a complex form of obstructive sleep apnea (OSA) may now be able breathe easier thanks to a device cleared this week by FDA.

The device, called the BiPAP autoSV, is made by Respironics (Murrysville, Pennsylvania), a developer of products serving the global sleep and respiratory markets. The device is designed to provide non-invasive ventilatory support for adult patients with OSA and respiratory insufficiency caused by central and/or mixed apneas and periodic breathing.

According to Dan Bevevino, VP/CEO of Respironics, theBiPAP autoSV is designed to treat a complex form of sleep apnea, called “central” apnea.

With central apnea, he told Medical Device Daily, “it’s not that you’re airway is blocked or closing, it’s just that basically your brain is not triggering your muscles to breathe.”

Bevevino said that when patients come into a sleep lab and are diagnosed with the standard form of OSA — characterized by snoring and interrupted breathing, with patients waking perhaps hundreds of times during the night and causing them to lose sleep — they are put on a positive airway pressure unit. Then, “essentially, they dial up that pressure until they see the apneas go away.”

For a small subset of patients who undergo this airway pressure test, Bevevino said central apnea is found to be the problem. “They’ve eliminated the obstructive sleep apnea . . . but for whatever reason, they’ve induced a central apnea. That type of patient is called a complex apnea patient,” he said.

The BiPAP autoSV system is designed to deliver optimal therapy for these complicated sleep-disordered breathing patients utilizing a multi-level algorithm. On a breath-by-breath basis, the 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, Bevevino said. The algorithm also calculates the patient’s spontaneous breathing rate and will automatically trigger a breath for the patient, should a sleep event occur.

The device, said Bevevino intervenes by “kicking up the [air] pressure to prevent those apneaic events and to get the patient’s breathing back to its normal level.”

It also combines Respironics’ BiPAP technology, Encore Pro Data Management Software, Digital Auto-Trak Sensitivity, integrated alarms and optional integrated heated humidification.

As with all its systems, Bevevino said a patient is first diagnosed in a sleep lab, titrated to determine what the optimal air pressure for the individual is and then given a prescription with that pressure listed. That prescription is then taken to a homecare provider to fill “much like a pharmacy fills a prescription for a drug.”

The BiPAP autoSV device was previously launched in Europe and Canada, and to date market acceptance has been very positive, the company said. Bevevino acknowledged that the system probably only will be used to treat a “single-digit-percent of the population, but it’s kind of yet to be completely proven just how big a part of the population it is.”

While the device may not necessarily be a big seller for Respironics, Bevevino said that it helps the company fill out its product line in its bid to be a dominant player in the treatment of all types of sleep apnea.

“It obviously expands our product offering and broadens the patient base that we can approach.”

Plans call for launch of domestic distribution later in the current fiscal year, and the company said it will not be changing its financial guidance or outlook based on this approval.

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