May 26, 2010 – The first angioplasty balloon catheter to integrate intravascular ultrasound (IVUS) imaging has gained CE-mark clearance in Europe. Volcano Corp. also announced today it completed its first clinical cases with the Vibe RX catheter in New Zealand.
The Vibe catheter is designed to quickly access, prepare and assess challenging lesions. IVUS guidance provides precise, targeted balloon dilatation with immediate confirmation of interventional results without additional catheters or catheter exchanges.
The catheter marks the beginning of Volcano’s planned transition from being strictly an intravascular imaging company toward an integrated interventional device therapy vendor.
"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," said Scott Huennekens, president and CEO of Volcano. "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 has successfully combined two important interventional tools - IVUS and balloon dilatation - into one powerful device," said Dr. John Ormiston, medical director at Mercy Angiography in Auckland, New Zealand. "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."
Volcano expects to begin commercial shipments of the Vibe RX in Europe in the third quarter of 2010.
For more information: www.volcanocorp.com