Respironics Receives 510(k) Clearance from FDA for BiPAP(R) autoSV(TM) Device Designed for Complicated Sleep-Disordered Breathin
07 Marzo 2007 - 2:30PM
PR Newswire (US)
MURRYSVILLE, Pa., March 7 /PRNewswire-FirstCall/ -- 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: http://www.respironics.com/. 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. DATASOURCE: Respironics, Inc. CONTACT: Dan Bevevino, Vice
President & CFO, Respironics, Inc., +1-724- 387-5235; General
Contact: Joe Calabrese, +1-212-827-3772, or Analyst Information:
Julie Tu, +1-212-827-3776, both of Financial Relations Board for
Respironics, Inc. Web site: http://www.respironics.com/
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