A BB&T

Valor Medical (San Diego), an early-stage medical device company that has developed an injectable device for the treatment of cerebral aneurysms, reported receiving approval for the first clinical trial in Europe has been received.

Clark Adams, CEO of Valor, called the approval “a major milestone” for the company. “We expect to be treating patients within the next 60 days and should have a second trial site approved at that time.”

He said that Valor will submit an investigational device exemption application to the FDA “soon” to begin human trials.

Branded as Neucrylate, the product is a liquid that is injected into a cerebral aneurysm through a micro-catheter placed from the femoral artery. When Neucrylate comes in contact with blood, the liquid changes into a solid material similar to a sponge. The surgical procedure for injecting Neucrylate will take less time, yet offers a more complete filling of the aneurysm as compared to coiling.

Dr. Charles Kerber, professor of neuroradiology, at the University of California at San Diego and founder of Valor, said, “Coiling has been a true advancement in the treatment of cerebral aneurysms. Neucrylate will advance the treatment even further by decreasing the surgical time and reducing the risks and failures associated with coiling.”

Cerebral aneurysms are more common in people over 65, they may be found in as high as 5% of the population. Smoking and hypertension appear to markedly increase the chance that one will develop a cerebral aneurysm.

About 30,000 people in the U.S. are diagnosed each year with a cerebral aneurysm. However, Valor said that estimates indicate up to 4.5 million individuals in the U.S. that have “silent,” that is, undiagnosed cerebral aneurysms.