Photos: Above, model of an aneurym filled with Axium coil. Below: Clean room at EV3, where Axium coils and other products are made. Bottom: EV3 employee shows the thinness of the coil, which varies in width from .0115 to .0145 inch. (Register photos by H. Lorren Au)
REVERSAL OF FORTUNES
EV3 is like an inventor who crashes his car, peers out from the wreck and declares that he’s happy to have found a good opportunity to design a totally new vehicle.
That approach is bearing fruit for the company, especially at its offices and manufacturing plant in Irvine.
But EV3 didn’t have that strategy in mind in 2002. Then, EV3 – more specifically, an affiliated company that later became part of EV3 – purchased the German firm Dendron GmbH in a $40 million deal to gain a quick entrée into the market for devices that treat brain aneurysms.
Instead the deal gave EV3 a quick entrée into patent litigation.
In 2003, a Dutch court decision barred EV3 from selling Dendron’s key product, called Sapphire – a catheter-based system for filling aneurysms with filaments so they won’t rupture and cause a stroke.
The underlying technology had been developed at UCLA, and the court ruled that EV3’s device infringed on the University of California’s patent, which it had licensed to Boston Scientific of Natick, Mass.
EV3 decided to set aside the old technology and make a fresh start, recalled Pascal Girin, president of the Irvine-based neurovascular division.
ASK THE CUSTOMER
“What do the customers want? What do they expect?” were the first questions EV3 asked as it wiped the slate clean. To get answers, the company interviewed neurosurgeons and interventional neuroradiologists worldwide, Girin said.
The focus of the conversations was on devices known as detachable coils, which are made by five medical-device companies in the United States – EV3 and Boston Scientific, plus Micrus Endovascular of San Jose; Microvention of Aliso Viejo; and Cordis of Warren, N.J.
Coils are one of three prominent methods for treating aneurysms, which are areas where the weakened wall of a blood vessel bulges outward into a balloon-like shape. In the United States, the dominant tactic is for a brain surgeon to clip off the aneurysm, but in Europe and less so in the United States, interventional neurocardiologists fill them with tiny coils of wire filaments or inject them full of a spongy polymer.
Packing an aneurysm with soft, curved stands of wire creates a tangle of filaments that impedes blood flow there. An injection of polymer can produce the same result. In each case, the filler allows the remaining blood in the aneurysm to clot so the aneurysm cannot burst.
“It’s like a pothole. You fill it with stuff,” which allows smooth passage of traffic to resume, said Earl Slee, EV3’s vice president for research and development.
Requests to EV3 during its conversations with customers and potential customers in hospitals, Slee said, included these three changes:
Finding a new way to detach the coils. The coils reach the aneurysm via a microcatheter, which the doctor threads through blood vessels from the groin, upwards past the heart, through the carotid artery in the neck and finally to the aneurysm site in the brain. The doctor then uses a wire inside the catheter to push the coil out and position it in the aneurysm. But the doctor can’t then reach in with a pair of scissors and snip off the coil from the catheter.
To solve that problem, most coils are manufactured with a short weak section that works as an electrical fuse. The doctor sends an electrical current up the wire until that weak section at the base of the coil eventually melts, detaching it.
EV3 found a quicker way. The base of the coil is a tiny ball that is blocked from detaching prematurely from the catheter tip because the catheter’s guide wire partially blocks the exit opening. With the new EV3 system, when the coil is in place the doctor simply retracts the guide wire from the opening, releasing the ball and detaching the coil.
That’s a feature of the new Axium coil system, which EV3 launched late last year as a successor to the jinxed Sapphire and its earlier substitutes, the Nexus and NXT coil systems.
Simplicity. Doctors said they wanted a less confusing array of options. Coils are roughly the width of a human hair, but they come in a dazzling variety of widths and lengths. Five companies offer them in a total of more than 600 varieties.
In response, EV3 limited its line of coils to about 55, ranging from long, thick ones that are laid down first, around the edges of an aneurysm, to short, thin ones that fill in the middle of the aneurysm.
Safety. A wire could cause a rupture by poking a hole in an aneurysm. To avoid that, EV3 makes its Axium coils of a relatively soft platinum-tungsten alloy, as most coil makers do. It also molds them like a spring, so the coil curves in on itself instead of sticking out straight.
WE’RE NO. 2
EV3 estimates that worldwide it’s the No. 2 maker of neurovascular devices, including its Solitaire stents and its market-leading Onyx aneurysm-filling polymer. Boston Scientific is No. 1. But EV3 is only No. 4 or No. 5 in coil sales, a market totaling an estimated $330 million a year.
The company’s new leader plans to change that. Bob Palmisano, who took over as chief executive in the spring, is already putting into effect the management techniques he learned at the head of other medical-device companies.
Most recently, he led the optical-laser company IntraLase of Irvine until it was purchased last year by Advanced Medical Optics of Santa Ana.
“Moving from ophthalmology to neurovascular, there’s a learning curve,” he said, “but the management issues are the same.”
Palmisano started work at EV3 in April and promptly led a corporate retreat in May that identified new corporate goals, with project teams assigned to pursue each one.
The Axium team is preparing for the launch of coils made of nylon and, once again, focusing on customer relations.
In the past year, “Axium had a very successful launch internationally – we blew the door off – but we weren’t nearly as successful in the United States,” Palmisano said. American doctors still prefer to clip off aneurysms rather than filling them, and EV3 hopes Axium can help to change that.
“We want a dominant market share in coils,” Palmisano said.
(This post was revised Sept. 18 to correct the indirect quote from Pascal Girin, who said the company contacted neurosurgeons and interventional neuroradiologists for advice.)
The people performing some of these procedures are called interventional neuroRADIOLOGIST and not cardiologist.