Volcano has completed the first clinical cases using the new Eagle Eye Platinum digital Intravascular ultrasound (IVUS) catheter. The procedures were performed in seven centers within the US. Commercial launch of Eagle Eye Platinum in the US is expected in June 2010.
Volcano has recently received 510(k) clearance from the FDA to market the Eagle Eye Platinum digital IVUS catheter in the US. The company said that the Eagle Eye Platinum is the third generation of catheters in the Eagle Eye product line.
Volcano said that, like Eagle Eye Gold, the Eagle Eye Platinum catheter offers plug-and-play functionality as well as grayscale IVUS, VH IVUS for plaque characterization, and ChromaFlo for imaging blood flow.
David Sheehan, president of IVUS and physiology business units at Volcano, said: “Our customer research of the most important IVUS catheter features found that both improved deliverability and the ability to easily estimate lesion length were vital. We designed the Eagle Eye Platinum to directly meet those needs. Deliverability was addressed with a more tapered tip, smoother design, and proprietary new GlyDx hydrophilic coating.
“The overwhelming response in clinical use thus far is that there is a remarkable difference physicians can feel, even through stents and challenging lesions. Plus, the three new radiopaque markers provide instant information, facilitating a more precise lesion length estimate, right on the angiogram.”
Joe Burnett, executive vice president of marketing at Volcano, said: “There are two trends in interventional cardiology for which the Eagle Eye Platinum is especially well-suited. First, more and more procedures are performed using the radial approach, where physicians access the vasculature through the smaller arteries in the arm versus the larger femoral artery in the leg.
“In these cases, smaller guide catheters are commonly used and there is often less room near the arm for an external pullback device. The Eagle Eye Platinum is the only FDA cleared IVUS catheter that is compatible with smaller five French (5F) guides. Plus, the new radiopaque markers for length estimation decrease the reliance on pullback devices, making this catheter better suited for the radial technique.”
Sheehan, said: “The last couple of years have been challenging for medical device makers to invest and deliver new, innovative products to the cardiac cath lab. We are thrilled to bring such a significant improvement in catheter performance to our full line of imaging catheters, and to give clinicians yet another precision-guidance PCI tool from which to choose.”