ROANOKE, Va.--(BUSINESS WIRE)--Luna Innovations (NASDAQ:LUNA - News) 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(TM) (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.
Contact: Luna Innovations Incorporated Media Contact: Karin Clark, 540-769-8400; kclark@lunainnovations.com or Qorvis Communications Investor Contact: Sally Beerbower, 703-744-7800; ir@lunainnovations.com
Source: Luna Innovations
