Volcano Receives Clearance for Eagle Eye Platinum and Acquires Lumen's Xtract Catheter

February 9, 2010—Volcano Corporation (San Diego, CA) announced that it has received 510(k) clearance from the US Food and Drug Administration to market the Eagle Eye Platinum digital intravenous ultrasound (IVUS) catheter in the United States. Commercial release of the Eagle Eye Platinum is expected in the second quarter of 2010. The device offers grayscale IVUS, Volcano's VH IVUS tissue characterization technology, and Volcano’s ChromoFlo imaging modalities. The Eagle Eye Platinum features additional radiopaque markers and improved deliverability compared to its predecessor, Eagle Eye Gold, the company stated.

Volcano also announced that it has acquired the Xtract thrombus aspiration catheter device line from Lumen Biomedical, Inc. (Maple Grove, MN). In May 2009, Volcano became the exclusive global distributor of the Xtract catheter, which supports the care of ST-elevation myocardial infarction (STEMI). The device features a large, single-lumen design, circular right-angle tip, and curved directional distal segment, the company stated.

Volcano noted that as a result of the strength of recent clinical studies, a new recommendation acknowledging that the use of aspiration thrombectomy is reasonable to treat STEMI was a key change in the updated STEMI and percutaneous coronary intervention guidelines issued in December 2009 by the American Heart Association, the American College of Cardiology, and the Society for Cardiovascular Angiography and Interventions.