Interventional device developer Rubicon Medical has completed enrollment for clinical testing of its Rubicon Filter in Europe, according to the Salt Lake City-based firm.
The Rule-SVG clinical study involves 30 cases at hospitals in Germany and Italy that have tested the device in both saphenous vein grafts and native coronary arteries, including high-risk stenting procedures, the company said.
Rubicon plans to use the collected data to generate the necessary reports and file for regulatory approval for marketing clearance for the Rubicon Filter in Europe. The product is also undergoing CE Mark clinical studies in Europe for use in carotid stenting procedures.
The device is designed for use downstream from a bloodstream blockage to allow the capture and removal of dislodged embolic material. The product is a guidewire-based filter that is deployed without the use of a catheter, making it smaller and easier to navigate through blood vessels, the firm said.
Rubicon said it has not begun trials on the device in the U.S., but anticipates their beginning in 2004.
By AuntMinnie.com staff writersFebruary 5, 2004
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