Since the late 1980s, physicians have been treating brain aneurysms by using little metal coils to create a stagnation of blood in the aneurysm so that a clot forms and takes the pressure off of it during a minimally invasive procedure. Although coiling was a big advancement over the previous method of opening a patient's skull and inserting a metal clip into their brain, it too has its limitations, according to Craig Adams, CEO of Valor Medical (San Diego).

Adams told Medical Device Daily that only so many coils can be packed into the aneurysm at a time and if the coils shift or compress which they do about 15% to 30% of the time, he says then the patient is in real trouble because putting more coils in is difficult at best and increases morbidity at worst.

So Valor is developing a device that could be introduced into the aneurysm as a liquid and, when edwit touches blood, turns into a solid, sponge-like material. The compound is injected into the aneurysm with a microcatheter that is inserted into the femoral artery in the groin and then passed up into the brain. This procedure takes about an hour, compared to coiling, which can take up to four hours.

"It's really cool," Adams said. "I know that doesn't sound technical or scientific, but when we saw the animal data we were ecstatic."

Adams said the history of Neucrylate begins with Charles Kerber, MD, of the University of California San Diego (UCSD) who began searching for a better way to treat aneurysms years ago.

Neucrylate is based on the compound cyanocrylate, better known as Super Glue or Krazy Glue, which is where it gets its viscosity and why it sticks together instead of breaking away. But Super Glue also turns into a hard plastic when it hits the air and is generally thought of as being toxic not qualities that would be good if inserted into a person's brain.

"But if we add biologically inert plasticizers and stabilizers we can change the polymer into a more flexible material, a material compatible with the motion of arteries," Valor said. "So the priceless cyanocrylate property which is the basis of this device is its ability to change from a liquid to a solid in a few seconds when it contacts bodily fluid, especially blood. But it is the additives that make it ideal for human use."

Also, Adams said, the company's animal data has shown that tissue cells start growing through the sponge-like material.

"Tissue actually grows over the neck of the aneurysm, the neck is where the aneurysm starts ballooning, and the tissue grows across the sponge," Adams said.

Kerber reported early results on the use of Neucrylate this week at the American Society of Neuroradiology (Oak Brook, Illinois) conference in New Orleans.

"The patients have had very positive results and to date the accumulated patient implant times have reached 1,400 days," Kerber said.

Adams said Valor will be expanding the trial sites in Europe within a few months and expects to begin trials in the U.S. later this year, pending approval of its IDE. He said the company anticipates launching Neucrylate in Europe by early 2010.

"The physicians that we bring in for training are amazed how easy it is to use and how much less time it takes because these individuals are, if you can imagine, working in somebody's brain," Adams said.

Once the catheter is in place, the treatment time is only a couple of minutes, the company noted.

"Time reduction is a major driver and the second major driver is being able to totally fill the aneurysm," Adams said. "The third big driver is that everyone thinks of the aneurysm as a plumbing problem, 'let's go fill it up,' but the problem is because of the blood flow."

Sean Pakbaz, MD, also of UCSD, has performed all the implants of Neucrylate to date, according to the company.

"The more I use Neucrylate, the more I'm impressed with how it works. Reducing the time it takes to treat an aneurysm is always a major goal when working in the brain. Implanting Neucrylate takes a lot less time than implanting coils. Neucrylate also fills the aneurysm compared to coils, which only fill 30% to 40% of the aneurysm," Pakbaz said.

Valor was formed as a Delaware C Corporation in January 2007.