New Cerebral-Aneurysm Device Cleared in Europe

ev3, a Plymouth, MN-based endovascular device firm, has received CE Mark approval for a new product that treats cerebral aneurysm. The Axium Detachable Coil System was approved for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.

Coiling procedures involve the delivery of platinum coils to the aneurysm via a small microcatheter. While still maintaining normal blood flow, the coils are threaded through the catheter into the aneurysm until the ballooned area is completely filled.

Using coiling to treat cerebral aneurysms is not new, but ev3, whose name stands for the three endovascular markets it occupies — peripheral vascular, cardiovascular and neurovascular — says its device was crafted with a neurosurgeon’s “wish list” in mind. The company says Axium boasts the following benefits:

–A high degree of coil conformability, which facilitates the physician’s goal of more easily and completely filling and packing the aneurysm, regardless of its shape or size.

–Coil softness combined with stretch resistance, which allows the coil to be positioned or repositioned within the aneurysm without adding to the risk of bleeding or hemorrhagic stroke.

–Ease of coil placement through the microcatheter, providing the physician with enhanced control and deliverability.

–Rapid, safe and simple detachment of the coil through a proprietary, micro-machined and first-of-its-kind device that offers instantaneous coil detachment without the use of wires or syringes. This feature facilitates precise and rapid coil deployment while minimizing procedure time, which may be especially important in a ruptured aneurysm or when blood flow to the brain has been restricted.

The European clearance comes one week after ev3 offered $780 million for Redwood City, CA-based FoxHollow Technologies. A successful merger would create a combined endovascular company with a $1.7 billion market cap.

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