News | May 21, 2007

Newly Cleared Blood Circuit Monitor Detects Gaseous Emboli in Real Time

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

Related Content

FDA clears Claret Medical Sentinel embolic protection device for TAVR
Feature | Heart Valve Technology| June 09, 2017
June 5, 2017 – The U.S.
Contego Medical Receives CE Mark for Vanguard IEP Peripheral Balloon Angioplasty System
News | Peripheral Artery Disease (PAD)| May 17, 2017
Contego Medical LLC announced recently that it has received CE Marking of its Vanguard IEP Peripheral Balloon...
PinnacleHealth Initiates Clinical Study of TriGuard Embolic Protection Device
News | Embolic Protection Devices| April 11, 2017
Through a new clinical trial, patients at Harrisburg, Pa.-based PinnacleHealth have access to an investigational device...
Cardiogard embolic protection system for surgical valve reaplacement

The CardioGard embolic protection system for surgical aortic valve replacement.

Feature | Embolic Protection Devices| March 22, 2017
March 22, 2017 — Two U.S.
InspireMD, CGuard embolic protection system, EPS, clinical data, internal carotid artery stenosis, ICA
News | Stents Carotid| November 18, 2016
November 18, 2016 — InspireMD Inc.
Sponsored Content | Videos | Heart Valve Technology| November 08, 2016
Studies have shown transcatheter aortic valve replacement (TAVR) has an increased risk of stroke and cerebral damage
TAVR, post-procedure, brain lesions, delirium, TCT 2016, Peter R. Stella
News | Heart Valve Technology| November 07, 2016
Keystone Heart Ltd. announced that data presented at the Transcatheter Cardiovascular Therapeutics (TCT) 2016...
Sentinel, TAVR, TAVI, embloic protection
News | Heart Valve Technology| November 07, 2016
November 7, 2016 – A multicenter randomized trial evaluating the role of embolic protection using the Sentinel device
Keystone Heart, TriGuard Embolic Protection Device, real-world results, PCR London Valves Conference 2016
News | Embolic Protection Devices| September 29, 2016
Keystone Heart Ltd. recently announced the safety and efficacy of the TriGuard Cerebral Embolic Protection device...
Overlay Init