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Volcano VIBE RX Vascular Imaging Balloon Catheter Gets CE Mark

Volcano has received CE mark approval for VIBE RX Vascular Imaging Balloon Catheter, which can access, prepare, and assess challenging lesions. The company has also completed its first clinical cases with the VIBE RX in New Zealand.

Volcano has added that the Intravascular ultrasound (IVUS) guidance provides precise, targeted balloon dilatation with immediate confirmation of interventional results. Volcano expects to begin commercial shipments of the VIBE RX offering in Europe in the third quarter of 2010.

John Ormiston, medical director at Mercy Angiography in Auckland, New Zealand, said: “Volcano has successfully combined two important interventional tools IVUS and balloon dilatation into one powerful device. Physicians will have an attractive alternative to using separate IVUS and balloon dilatation catheters in a procedure.

“The use of imaging for more precise lesion assessment and stent placement has certainly benefited my patients. Integrating imaging directly onto the therapy device removes another barrier to IVUS use. I am pleased to see and be a part of the innovations Volcano is bringing to the cath lab and patients.”

Scott Huennekens, president and chief executive officer of Volcano, said: “VIBE RX represents the first of what we believe will be many Volcano image-guided therapy devices designed to allow physicians to see more detail right at the point of the therapy. Although our initial focus is on cardiovascular applications, we believe that this platform can and will be leveraged to many other applications throughout the body.

“We plan to pursue this broader platform expansion through our internal development and through partnerships with other device manufacturers. Volcano is well-positioned to lead this movement in combining therapy and on-board imaging.”