Luna Innovations Submits FDA 510(k) Application For EDAC QUANTIFIER Monitor

Roanoke, VA - Luna Innovations announced recently that it has submitted its 510(k) application to the U.S. Food and Drug Administration for the EDAC (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 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.

SOURCE: Luna Innovations