Tuesday, medical device maker Volcano Corp. (VOLC) announced that it has received clearance from the Food and Drug Administration to market Eagle Eye Platinum digital IVUS catheter in the United States.
IVUS or Intravascular Ultrasound is a catheter based system that allows physicians to acquire images of diseased vessels from inside the artery.
According to the company, the Eagle Eye Platinum digital IVUS catheter offers all the benefits of the predecessor Eagle Eye Gold catheter, plus improved deliverability and the convenience of additional radiopaque markers.
The Eagle Eye Platinum is the third generation of catheters in the Eagle Eye product line and its commercial release in the U.S. is expected in the second quarter of 2010.
Volcano noted that Eagle Eye catheters have been used in over 500,000 procedures worldwide to date.
Last month, the company received CE mark for its OCT (Optical Coherence Tomography) imaging system and catheter. The CE marking gives companies easier access into the European market to sell their products without adaptation or rechecking.
Volcano's OCT product line is expected to complement its existing line of IVUS imaging catheters and pressure guide wires used for coronary imaging and lesion assessment. The commercial release of the first OCT system in Europe is expected in early 2011.
Volcano plans to use the OCT system in the U.S. and South America as part of a U.S. regulatory trial during 2010.
In a separate press release, the company announced that it has completed the acquisition of Xtract Thrombus Aspiration Catheter device line from Lumen Biomedical.
According to Volcano, the acquisition helps to build a strategic portfolio of diagnostic and therapeutic tools to help patients with coronary artery disease at all levels of complexity, including acute myocardial infarction or heart attacks.
The company is scheduled to report its fourth-quarter and full-year financial results in early March.
For the fourth-quarter ended December 31, 2009 the company expects revenue to be about $71 million, which represents an increase of approximately 44% over the comparable quarter in 2008. Wall Street analysts have a consensus revenue estimate of $67.91 million.
For the full year of 2009, Volcano anticipates total revenues to be approximately $228.0 million, reflecting year-over-year revenue growth of approximately 33%. Analysts polled by Thomson Reuters have revenue estimate pegged at $224.78 million.
VOLC is currently up 1.80% trading at $19.76.
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