Respironics Receives 510(k) Clearance From FDA For BiPAP(R) AutoSV(TM) Device Designed For Complicated Sleep-Disordered Breathing Patients
October 01, 2017
Respironics, Inc.
(Nasdaq: RESP) today announced that the U.S. Food and Drug Administration
(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.
The Company stated that it will not be changing its financial guidance
or outlook based on this announcement.
Respironics is a leading developer, manufacturer and distributor of
innovative products and programs that serve the global sleep and
respiratory markets. Focusing on emerging market needs, the Company is
committed to providing valued solutions to help improve outcomes for
patients, clinicians and health care providers. Respironics markets its
products in 131 countries and employs over 4,900 associates worldwide.
Further information can be found on the Company's Web site:
respironics.
This document contains forward-looking statements, including statements
relating to, among other things, developments in the healthcare industry;
the success of the Company's marketing, sales, and promotion programs;
future sales, acceptance, and quality of the Company's products and
programs; the timing and success of new product introductions; new product
development; anticipated cost savings; FDA and other regulatory
requirements, enforcement actions, product recalls or related field
actions; future results from acquisitions and strategic investments; growth
rates in foreign markets; regulations and other factors affecting
operations and sales outside the United States; foreign currency
fluctuations; the effects of a major earthquake, cyber-attack or other
catastrophic event that results in the destruction or disruption of any
critical business or information technology systems; customer consolidation
and concentration; increasing price competition and other competitive
factors in the manufacture, distribution, and sale of products; interest
rate fluctuations; expiration of intellectual property rights; intellectual
property and related litigation; other litigation; future levels of
earnings and revenues; the number of equity awards granted to employees and
changes in the Company's stock price; and third party reimbursement; all of
which are subject to change. Actual results may differ materially from
those described in any forward-looking statements. Additional information
on potential factors that could affect the Company's financial results are
included in the reports filed with the SEC, including the reports on Form
10-K, 10-Q and 8-K.
Respironics, Inc.
respironics