May 22, 2007 — Luna Innovations has announced it has received a market clearance letter in response to its 510(k) application to the FDA for the EDAC (Emboli Detection and Classification) QUANTIFIER, a cardiopulmonary bubble detector that uses quantitative ultrasound technology to noninvasively detect gaseous emboli in an extracorporeal bypass circuit line.
Luna says it will market and sell the EDAC QUANTIFIER for clinical use in the U.S.
"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.
For more information visit www.lunainnovations.com.