Luna Innovations Blood Circuit Monitor Receives FDA ClearanceLuna Innovations' new medical device, the EDAC(TM) QUANTIFIER, a bl
21 Maio 2007 - 9:40AM
Business Wire
Luna Innovations (NASDAQ:LUNA) announced today that it has received
a market clearance letter in response to its 510(k) application to
the U.S. Food and Drug Administration for the EDAC� (Emboli
Detection and Classification) QUANTIFIER. This cardiopulmonary
bubble detector is an innovative medical device that uses
quantitative ultrasound technology to non-invasively detect gaseous
emboli in an extracorporeal bypass circuit line. Luna will market
and sell the EDAC QUANTIFIER for clinical use in the United States.
Emboli can be air bubbles or solid matter, variable in their size
and consistency, and can enter the extracorporeal blood circuit
during invasive medical procedures such as cardiopulmonary bypass
surgery. Many researchers and clinicians agree that one of the most
significant risks associated with emboli is brain damage caused by
gaseous microemboli which are introduced into the cerebral blood
flow during such procedures. "The dramatic new emboli data and the
graphic display of the EDAC QUANTIFIER will open clinicians� eyes
to a world of flowing microscopic gaseous emboli that we have not
been able to visualize previously," said Jeffery B. Riley MHPE,
CCT, Program Director and Assistant Professor-Clinical Allied
Medicine, The Ohio State University, who has been using Luna�s EDAC
QUANTIFIER in a research setting since October 2006. �Adopting the
EDAC QUANTIFIER gives us the opportunity to reduce one of the major
side-effects of cardiopulmonary bypass, neurocognitive problems
which can be caused by embolism, and improve the care of our
cardiac surgical patients. Additionally, the hardware and
user-interface for the EDAC QUANTIFIER are advance-of-the-art,
accurate, and easy to use during the procedure." Luna�s EDAC
QUANTIFIER simultaneously monitors up to three bypass circuit
locations, provides count rates up to at least 1000 per second and
detects emboli as small as 10 microns in diameter. In addition, the
blood circuit monitor also provides real-time feedback and archived
data on critical information such as emboli counts and volume
estimates. This new device offers a user-friendly interface and
requires minimal training for use. �The EDAC market clearance
exemplifies the Luna Innovations business model in the ever
demanding high technology arena of cardiovascular bypass surgery,�
said Kent Murphy, Chairman and CEO of Luna Innovations. �The EDAC
product emerged through innovative engineering originally funded
from research with the Navy and we will continue to advance and
expand our core ultrasound technology.� Luna�s EDAC QUANTIFIER
comes configured in a standalone system with a three-channel,
ultrasonic pulser-receiver unit, a touch-panel computer and
ultrasound transducers. It is available immediately with an
estimated six to eight week delivery time. Additional information
can be found at www.lunamedicalproducts.com or by contacting
support@lunamedicalproducts.com. About Luna Innovations: Luna
Innovations Incorporated develops and manufactures new-generation
products for the healthcare, telecommunications, energy and defense
markets. Our products are used to measure, monitor, protect and
improve critical processes in the markets we serve. Through its
disciplined commercialization business model, Luna has become a
recognized leader in transitioning science to solutions. Luna is
headquartered in Roanoke, Virginia. Additional information can be
found at www.lunainnovations.com. FORWARD LOOKING STATEMENTS This
press release includes information that constitutes
�forward-looking statements� made pursuant to the safe harbor
provision of the Private Securities Litigation Reform Act of 1995,
including but not limited to the statements that adopting the EDAC
QUANTIFIER gives physicians the opportunity to reduce one of the
major side-effects of cardiopulmonary bypass surgery and that the
company will continue to advance and expand its core ultrasound
technology. Statements that describe the company�s business
strategy, goals, objectives, prospects, opportunities, plans or
intentions are also forward-looking statements. Actual events or
results may differ materially from the expectations expressed in
such forward-looking statements as a result of various factors,
including risks and uncertainties, many of which are beyond the
company�s control. Factors that may affect the future results of
Luna Innovations are set forth in its Annual Report on Form 10-K,
its periodic reports on Forms 10-Q and other filings with the
Securities and Exchange Commission (�SEC�). These filings are
available at the SEC�s website at http://www.sec.gov and at the
company�s website at http://www.lunainnovations.com. The statements
made in this press release are based on information available to
the company as of the date of this release and Luna Innovations
undertakes no obligation to update any of the forward-looking
statements herein after the date of this press release.
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