LUNA up 60% this morning on news that the FDA has approved a blood circuit monitor.
Luna Innovations Blood Circuit Monitor Receives FDA Clearance
Monday May 21, 8:40 am ET
EDAC(TM) QUANTIFIER Counts and Measures Gaseous Emboli in Real-Time
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.
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