Tuesday, May 22, 2007
Luna gets approval for heart device
The EDAC Quantifier detects air bubbles in patients undergoing heart bypass surgery.
The news from both the FDA and the market was good for Luna Innovations on Monday.
The Food and Drug Administration gave the Roanoke-based company the go-ahead to begin selling a medical device that could save the lives of people having cardiac surgery. Luna's stock shot up on the news, ending the day at $5.06 -- almost 69 percent above its close Friday.
The news was good for the region as well because Luna has acted as a symbol of the often-bumpy trip Southwest Virginia is making from manufacturing center to high-tech economy.
The new device is the EDAC -- emboli detection and classification -- Quantifier. It's used to monitor the blood of a surgery patient whose heart has been temporarily replaced by a machine.
During open-heart procedures, such as a bypass, a patient's heart is stopped and replaced by an external pump while the surgeons work on the organ.
Tubes connect the pump to the patient's veins and arteries, but sometimes the connections between man and machine aren't perfect. As with two garden hoses connected with duct tape, there is a chance that some air will leak in. Air bubbles on roses aren't a problem, but air bubbles and other contaminants in the bloodstream are.
Known collectively as emboli, they have the potential to cause heart or brain damage.
"I've had a fair amount of experience worrying about this particular problem," said Paul Frantz, a cardio-thoracic surgeon and medical director for cardiac services for Carilion, which owns stock in Luna. "Fortunately this doesn't occur very often."
But when it does, Frantz said, "it can have very dramatic [effects]. It can cause stroke, it can cause a heart attack with the bubble blocking the small arteries in the brain or the coronary blood supply."
Because of that danger, surgeons use bubble detection systems to monitor blood flow. Luna's EDAC Quantifier is designed to be a major improvement in that field.
The EDAC Quantifier can identify at least 1,000 emboli every second, some as small as 10 microns in diameter, or 1/20th the width of a typical human hair. If it detects dangerous emboli levels, it warns the surgical team, which can check for leaks caused by things such as loose sutures.
"There are many ways that people hypothesize that they get in [to the bloodstream]," said Brooke Williams, medical products manager for Luna. Emboli can arise if the patient's blood is cooled too quickly, for example, or if medication is introduced at the wrong rate.
The EDAC Quantifier also helps future patients by allowing the medical staff to note whether certain products work better in certain situations -- one type of equipment might cause a larger number of emboli when used with particular types of patients.
"This will allow them to decide what their best practices should be" by providing detailed data about each procedure, which can help paint the big picture, Williams said.
After about a six-month review process, the FDA gave Luna a market clearance letter, allowing the company to begin selling the $40,000 machines to hospitals. It had previously only been available to researchers.
Frantz saw the EDAC Quantifier's usefulness quickly. "Any improvement in our ability to detect air within the circuit is a real plus," he said.




