Healthcare Industry News: Terumo
News Release - May 3, 2007
Luna Innovations Submits FDA 510(k) Application for EDAC(TM) QUANTIFIER MonitorROANOKE, Va.--(HSMN NewsFeed)--Luna Innovations (NASDAQ: LUNA ) announced today that it has submitted its 510(k) application to the U.S. Food and Drug Administration for the EDAC(TM) (Emboli Detection and Classification) QUANTIFIER. This innovative medical device uses quantitative ultrasound technology to non-invasively count and measure gaseous emboli in the extracorporeal blood circuits. FDA clearance would enable Luna Innovations to market and sell the EDAC QUANTIFIER for clinical use in the United States.
The EDAC QUANTIFIER represents a breakthrough in cardiothoracic surgery. The instrument is designed to reliably detect harmful gaseous emboli during open-heart surgery. Gaseous emboli are air bubbles that may enter or are created in the blood circuit during critical and invasive medical procedures such as cardio- pulmonary bypass surgery. The EDAC(TM) QUANTIFIER can provide the surgical team with data on the quantity and volume of gaseous emboli at multiple locations in extracorporeal circuits during a procedure.
David Blaker, Vice President of Medical Products, commented, "The FDA submission represents a significant milestone and growth opportunity for Luna Innovations. Research studies acknowledge the relationship between an increased number of emboli delivered to the brain and an increase in the number of neurological or neurocognitive deficits in patients after surgery. Using innovative and sophisticated technology, coupled with noninvasive monitoring techniques, the EDAC QUANTIFIER exemplifies Luna's commitment to providing medical instruments that will improve the quality of patient care."
In a related announcement, Luna Innovations has hired Brian Murach as its Director of North American Medical Products Sales. Murach has extensive clinical experience as a Certified Physician Assistant and more than 16 years experience in medical equipment sales. He is the former National Sales Manager for Terumo Cardiovascular Systems, and has held the positions of Regional Sales Manager with Spencer Technologies, and National Sales Manager with Neuroscan Medical Systems/DWL Systems.
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 statement that FDA clearance would enable the company to market and sell the EDAC QUANTIFIER for clinical use. 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 10K, its periodic reports on Forms 10-Q and other filings with the Securities and Exchange Commission ("SEC"). These things are available at the SEC's website at http://www.sec.gov and at Luna Innovations' 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.
Source: Luna Innovations
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