PLYMOUTH, Minn.--(BUSINESS WIRE)--July 5, 2006--Lumen Biomedical, Inc. announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) to market its first product in the United States, the Xtract(TM) Aspiration Catheter. The new device is indicated for use in the removal of thrombi (clots) and soft emboli from vessels throughout the body. Clots can restrict or interrupt blood flow within an artery, creating complications in patients undergoing intravascular procedures. The Xtract(TM) Aspiration Catheter can be used with other devices during vascular intervention procedures, such as stents and embolic protection devices, to restore normal blood flow after blockages created by clots within the vessels.
“This is a major milestone for LBI - receiving our first FDA clearance,” said Matthew Ogle, President and CEO of Lumen Biomedical. “It validates many hours of hard work by our group of talented development professionals. The Xtract(TM) Aspiration Catheter, will provide cardiologists a novel tool to treat patients who have arteries laden with thrombus, such as patients experiencing acute myocardial infarction (acute heart attack). Its directional tip and favorable torque response allows physicians to treat difficult to reach segments of vessels. We are confident that with this device they will be able to successfully and completely remove thrombus from vessels that otherwise could not have been cleared.”
The Lumen Biomedical, Inc (LBI) Xtract(TM) Aspiration Catheter is designed to remove fresh, soft emboli or thrombi from the arterial system. It is a single-use, 0.014" guidewire compatible, temporary intra-vascular extraction and aspiration catheter system. Lumen Biomedical, Inc. (LBI) is a medical device company established in 2003. The Xtract(TM) Aspiration Catheter will also be part of LBI’s FiberNet® Embolic Protection System, which is currently under clinical evaluation in the United States.
Contact: Lumen Biomedical, Inc. Roy Hosek, 763-577-9600
Source: Lumen Biomedical, Inc.
