Micro Therapeutics Inc., Irvine, received FDA approval for a clinical trial of its Onyx system for brain aneurysm treatment.
The 15-site, 138-patient trial will include Beth Israel Medical Center in New York, Methodist Hospital in Houston and State University of New York in Buffalo, N.Y.
Micro Therapeutics’ system delivers a liquid through micro catheters into aneurysms or other problem areas in arteries or veins. The liquid then turns into a spongy polymer designed to block blood flow to the affected area, preventing hemorrhaging.
“The use of Onyx in treating aneurysms is the ‘crown jewel’ because of its large commercial potential,a market segment we estimate could exceed $800 million in five years,” said John Rush, Micro Therapeutics’ president and chief executive, in a statement. Previous studies showed that Onyx could work well on wide-neck, large and giant aneurysms that lead to strokes, according to Rush.
Micro Therapeutics officials said they planned to file a pre-market approval application for Onyx with the FDA in the second half of next year.
