IntriCon Receives FDA 510(k) Marketing Clearance for Centauri Cardiac Diagnostic Monitor
August 11 2011 - 10:30AM
Business Wire
IntriCon Corporation (NASDAQ: IIN), a designer,
developer, manufacturer and distributor of miniature and
micro-miniature body-worn devices, today announced it has received
510(k) marketing clearance from the U.S. Food and Drug
Administration (FDA), for the Centauri Ambulatory Patient ECG, its
first-generation wireless cardiac diagnostic monitoring (CDM)
device. The Centauri combines event recording with wireless
transmission of patient data allowing physicians to continuously
monitor patient cardiac events remotely.
Mark S. Gorder, president and chief executive officer at
IntriCon said, “With rising health care costs, we are excited to
offer a device that will not only improve patient quality of life,
but also reduce treatment costs by providing the ability to
identify asymptomatic cardiac events remotely. The Centauri follows
current industry trends of shifting patient care from expensive
health-care settings to the home which not only reduces costs but
improves patient comfort.”
The Centauri device provides diagnostic evaluation of patients
who experience transient symptoms that may suggest cardiac
arrhythmia. With continuous monitoring, automatic arrhythmia
detection and wireless transmission of the recorded cardiac
activity to a licensed physician for review, Centauri offers
flexibility and comfort not found in traditional devices.
Given the timing of the FDA clearance, IntriCon expects to
release the product in the third quarter of 2011 and anticipates
modest revenue contributions in the 2011 fourth quarter.
About IntriCon CorporationHeadquartered in Arden Hills,
Minn., IntriCon Corporation designs, develops, manufactures and
distributes miniature and micro-miniature body-worn devices. The
company is focused on three key markets: medical, hearing health,
and professional audio communications. IntriCon has facilities in
the United States, Asia and Europe. The company’s common stock
trades under the symbol “IIN” on the NASDAQ Global Market. For more
information about IntriCon, visit www.intricon.com.
Forward-Looking StatementsStatements made in this release
and in IntriCon’s other public filings and releases that are not
historical facts or that include forward-looking terminology such
as “may”, “will”, “believe”, “anticipate”, “expect”, “should”,
“optimistic” or “continue” or the negative thereof or other
variations thereon are “forward-looking statements” within the
meaning of the Securities Exchange Act of 1934, as amended. These
forward-looking statements include, without limitation, statements
concerning prospects in the miniature body-worn device arena, new
products and their timing, strategic alliances, future growth and
expansion, expansion into new manufacturing facilities, market
fundamentals, future financial condition and performance, prospects
and the positioning of IntriCon to compete in chosen markets and
the Company’s planned investments in research and development.
These forward-looking statements may be affected by known and
unknown risks, uncertainties and other factors that are beyond
IntriCon’s control, and may cause IntriCon’s actual results,
performance or achievements to differ materially from the results,
performance and achievements expressed or implied in the
forward-looking statements. These risks, uncertainties and factors
include, without limitation, risks related to the current economic
crisis, the risk that IntriCon may not be able to achieve its
long-term strategy, weakening demand for products of the company
due to general economic conditions, risks related to government
approval of the debt ceiling, risks related to the company’s
strategic alliances and joint venture, possible non-performance of
the Centauri, Scenic, Overtus, APT, Sirona, PhysioLink, wireless
glucose monitor and situational listening device products and other
technological products, the volume and timing of orders received by
the company, changes in the mix of products sold, competitive
pricing pressures, the cost and availability of electronic
components and commodities for the company’s products, ability to
create and market products in a timely manner, competition by
competitors with more resources than the company, government
regulation and review of products, foreign currency risks arising
from the company’s foreign operations, ability to satisfy and
maintain compliance with the covenants under the company’s loan
facility, the costs and risks associated with research and
development investments and other risks detailed from time to time
in the company’s filings with the Securities and Exchange
Commission, including the Annual Report on Form 10-K for the year
ended December 31, 2010. The company disclaims any intent or
obligation to publicly update or revise any forward-looking
statements, regardless of whether new information becomes
available, future developments occur or otherwise.
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