Lumen Biomedical Expands Product Line With FDA Clearance On Additional Xtract Catheter Sizes

Plymouth, MN - Lumen Biomedical, Inc. announced recently final clearance from the U.S. Food and Drug Administration (FDA) to market two additional sizes of their Xtract Aspiration Catheter in the United States. Now the Xtract Catheter, which is indicated for use in the removal of soft, fresh thrombi (clots) and emboli from arteries in the body, is available in two larger sizes (5 and 5.8 French) making it the largest catheter of this type now on the market. The smaller catheter size (4.2F) was granted FDA clearance June 2006. Clots can restrict or interrupt blood flow within an artery, creating severe complications in patients. With three Xtract Aspiration Catheter models available on the US market, physicians have greater flexibility to retrieve potentially life threatening blood clots with the widest variety of catheter sizes. Thromboses events can be caused by physiological conditions or from interventional procedures themselves, one such complication being stent thrombosis.

"Now that Xtract offers the largest lumen available for aspiration, physicians will have a better opportunity to extract a larger amount of thrombus when treating heavily thrombatic arteries," said Dr. Steve Yakubov, MidOhio Cardiology and Vascular Consultants. Dr. Yakubov was the first U.S. physician to use the Xtract in August of 2006.

The Lumen Biomedical, Inc (LBI) Xtract 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 intravascular extraction and aspiration catheter system. The Xtract features a braided shaft for responsive delivery and kink resistance, a large aspiration lumen, and a soft curved tip to negotiate obstructions and provide directional suction.

SOURCE: Lumen Biomedical, Inc.