ev3 Neurovascular Intervention Business Unit

EV3 is a global medical device company focused on catheter-based technologies for the endovascular treatment of vascular diseases and disorders. EV3 is organized into two business segments, cardio peripheral and neurovascular.

During 2009 the company generated total revenue of $430 million of which $165 million, or 38% of total were generated from its neurovascular intervention strategic business unit.

EV3 neurovascular product range include Embolic Coils, Liquid Embolics, Neuro Stents, Microcatheters, Occlusion Balloon Systems and Guidewires.

In the Embolic Coils category the company products include the NXT line of detachable coils which was introduced in the United States and Europe in 2004, the Nexus line of coils which was introduced in the United States and Europe in September 2005 and the Axium line of  detachable coils which was launched globally in the 4th quarter of 2007.

In the Liquid Embolics category the company products include the Onyx Liquid Embolic System.   Onyx is a proprietary biocompatible copolymer which is delivered, in liquid form, through microcatheters to blood vessels in the brain, where it fills a vascular defect and transforms into a solid polymer cast. Onyx offers a unique form, fill and seal approach to the interventional treatment of aneurysms and AVMs associated with hemorrhagic stroke.

In the neuro-stent segment EV3 we received a CE mark for the neurovascular use of its new stent platform, the Solitaire, in December 2007. The company initiated limited commercialization of the Solitaire platform, a self-expanding Nitinol stent, in Europe for use in bridging the neck of aneurysms to facilitate more secure coil placement, with thrombo-embolic disease to immediately restore blood flow and assist in the removal of clot burden and with intracranial stenotic disease where vessels within the brain become narrowed.

The Solitaire is fully retrievable and detachable, allowing for more precise placement and if required, replacement of the stent is possible. The company estimate that it will receive an HDE (humanitarian device exemption) from the FDA for the same indication in 2009.

In June 2009 ev3 announced the acquisition of 100% equity interest in Chestnut Medical Technologies, the developer of the Pipeline Embolization Device (PED), for $26 million in cash and approximately 5 million shares of common stock, 65% of total upfront consideration of $75 million with additional milestone-based contingent payment of up to $75 million.

Pipeline Embolization Device (PED), a braided bimetallic stent for exclusion of cerebral aneurysms through flow disruption, received CE Mark approval in June 2008 and is currently undergoing clinical trials in the US for an FDA filling.

Chestnut Medical has also an intracranial coil/stent foreign body retrieval system, the Alligator Retrieval Device, which was cleared by the FDA in March 2005.

ev3 has a dedicated neurovascular sales force of over seventy representatives worldwide with  two-third of this sales forces deployed in Europe. The company is forecasting a market of $350 million by 2013 for PED device and is predicting a possible US launch as early as 2011.