Medical device maker ev3 Inc. said Tuesday it finished filing for marketing approval of a device used to divert blood away from cerebral aneurysms during surgery.
Ev3 asked the Food and Drug Administration to clear the Pipeline Embolization Device. The company said the agency could schedule a review by an advisory panel later this year, and ev3 hopes the device will be approved in 2011. The company acquired the Pipeline device when it bought Chestnut Medical Technologies in 2009.
The company asked the FDA for premarket approval, meaning it aims to prove the device is equivalent to another product that has already been approved.
A cerebral aneurysm is a weak spot in the wall of a blood vessel inside the brain. Those weak spots can swell and burst, causing stroke or death. Ev3 said devices like Pipeline could be used in about one-fourth of aneurysm procedures, and estimated the market opportunity for the device at $350 million in 2013.
In midday trading, ev3 shares fell 9 cents to $19.41. Earlier, they rose 2.6 percent to reach a three-year high of $20.