SAN DIEGO, May 20 /PRNewswire-FirstCall/ -- Volcano Corporation (Nasdaq: VOLC) announced today the completion of the first clinical cases using the new Eagle Eye® Platinum digital IVUS catheter. The procedures were performed in seven centers within the United States. Commercial launch of Eagle Eye® Platinum in the U.S. is expected in June 2010.
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"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," commented David Sheehan, President of Volcano's IVUS and Physiology Business Units. "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."
After conducting one of the first clinical cases with Eagle Eye® Platinum, Dr. Craig Thompson, Associate Professor of Internal Medicine/Cardiology at Yale-New Haven Hospital, stated, "Physicians need devices that quickly get to where they are needed without requiring excess manipulation or extra dilations. In my experience, the Eagle Eye® Platinum catheter clearly represents a dramatic generational improvement in terms of deliverability and trackability in complex vascular anatomy. Ultimately, the enhancements of this catheter could increase usage of IVUS among physicians, allowing for more precision in the treatment of cardiovascular disease."
"There are two trends in interventional cardiology for which the Eagle Eye® Platinum is especially well-suited," said Joe Burnett, Executive Vice President of Marketing at Volcano. "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."
"The second trend is a focus on using less contrast and delivering less radiation to patients and staff during PCI procedures," added Burnett. "Again, these convenient radiopaque markers can assist physicians in lesion and stent length estimation by reducing the limitations of two-dimensional angiography, which could lead to the use of less contrast and fewer x-ray pictures from multiple angles."
"The last couple of years have been challenging for medical device makers to invest and deliver new, innovative products to the cardiac cath lab," continued Sheehan. "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."
Volcano received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the Eagle Eye® Platinum digital IVUS catheter in the United States.
About Volcano's Digital IVUS Catheters
The Eagle Eye® Platinum is the third generation of catheters in the Eagle Eye® product line. To date, Eagle Eye® catheters have been used in over 500,000 procedures worldwide. Like Eagle Eye® Gold, the Eagle Eye® Platinum catheter offers fast, plug-and-play functionality as well as grayscale IVUS, VH® IVUS for plaque characterization, and ChromaFlo® for imaging blood flow.
About Volcano Corporation
Volcano Corporation offers a broad suite of devices designed to facilitate endovascular procedures, enhance the diagnosis of vascular and structural heart disease and guide optimal therapies. The company's intravascular ultrasound (IVUS) product line includes ultrasound consoles that can be integrated directly into virtually any modern cath lab. Volcano IVUS offers unique features, including both single-use digital and rotational IVUS imaging catheters, and advanced functionality options, such as VH® IVUS tissue characterization and ChromaFlo®. Volcano also provides Physiology consoles and single-use pressure and flow guide wires and is developing a line of ultra-high resolution Optical Coherence Tomography (OCT) systems and catheters. Currently, more than 5,000 Volcano IVUS and Physiology systems are installed worldwide, with approximately half of Volcano's revenues coming from outside the United States. Volcano's wholly-owned subsidiary, Axsun Technologies, develops and manufactures optical monitors, lasers and optical engines used in telecommunications, medical imaging, spectroscopy and other industrial applications. For more information, visit the company's website at http://www.volcanocorp.com/.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this release regarding Volcano's business that are not historical facts may be considered "forward-looking statements," including statements regarding the potential benefits of the products and procedures described above, commercial release and market adoption of the company's technology, and the impact of clinical and other technical data. Forward-looking statements are based on management's current preliminary expectations and are subject to risks and uncertainties which may cause Volcano's results to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties that could cause actual results to differ from the results predicted are detailed in the company's annual report on Form 10-K, quarterly report on Form 10-Q and other filings made with the Securities and Exchange Commission. Undue reliance should not be placed on forward-looking statements which speak only as of the date they are made. Volcano undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.
SOURCE Volcano Corporation
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(Photo: http://www.newscom.com/cgi-bin/prnh/20100520/SF08130)
"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," commented David Sheehan, President of Volcano's IVUS and Physiology Business Units. "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."
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After conducting one of the first clinical cases with Eagle Eye® Platinum, Dr. Craig Thompson, Associate Professor of Internal Medicine/Cardiology at Yale-New Haven Hospital, stated, "Physicians need devices that quickly get to where they are needed without requiring excess manipulation or extra dilations. In my experience, the Eagle Eye® Platinum catheter clearly represents a dramatic generational improvement in terms of deliverability and trackability in complex vascular anatomy. Ultimately, the enhancements of this catheter could increase usage of IVUS among physicians, allowing for more precision in the treatment of cardiovascular disease."
"There are two trends in interventional cardiology for which the Eagle Eye® Platinum is especially well-suited," said Joe Burnett, Executive Vice President of Marketing at Volcano. "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."
"The second trend is a focus on using less contrast and delivering less radiation to patients and staff during PCI procedures," added Burnett. "Again, these convenient radiopaque markers can assist physicians in lesion and stent length estimation by reducing the limitations of two-dimensional angiography, which could lead to the use of less contrast and fewer x-ray pictures from multiple angles."
"The last couple of years have been challenging for medical device makers to invest and deliver new, innovative products to the cardiac cath lab," continued Sheehan. "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."
Volcano received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the Eagle Eye® Platinum digital IVUS catheter in the United States.
About Volcano's Digital IVUS Catheters
The Eagle Eye® Platinum is the third generation of catheters in the Eagle Eye® product line. To date, Eagle Eye® catheters have been used in over 500,000 procedures worldwide. Like Eagle Eye® Gold, the Eagle Eye® Platinum catheter offers fast, plug-and-play functionality as well as grayscale IVUS, VH® IVUS for plaque characterization, and ChromaFlo® for imaging blood flow.
About Volcano Corporation
Volcano Corporation offers a broad suite of devices designed to facilitate endovascular procedures, enhance the diagnosis of vascular and structural heart disease and guide optimal therapies. The company's intravascular ultrasound (IVUS) product line includes ultrasound consoles that can be integrated directly into virtually any modern cath lab. Volcano IVUS offers unique features, including both single-use digital and rotational IVUS imaging catheters, and advanced functionality options, such as VH® IVUS tissue characterization and ChromaFlo®. Volcano also provides Physiology consoles and single-use pressure and flow guide wires and is developing a line of ultra-high resolution Optical Coherence Tomography (OCT) systems and catheters. Currently, more than 5,000 Volcano IVUS and Physiology systems are installed worldwide, with approximately half of Volcano's revenues coming from outside the United States. Volcano's wholly-owned subsidiary, Axsun Technologies, develops and manufactures optical monitors, lasers and optical engines used in telecommunications, medical imaging, spectroscopy and other industrial applications. For more information, visit the company's website at http://www.volcanocorp.com/.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this release regarding Volcano's business that are not historical facts may be considered "forward-looking statements," including statements regarding the potential benefits of the products and procedures described above, commercial release and market adoption of the company's technology, and the impact of clinical and other technical data. Forward-looking statements are based on management's current preliminary expectations and are subject to risks and uncertainties which may cause Volcano's results to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties that could cause actual results to differ from the results predicted are detailed in the company's annual report on Form 10-K, quarterly report on Form 10-Q and other filings made with the Securities and Exchange Commission. Undue reliance should not be placed on forward-looking statements which speak only as of the date they are made. Volcano undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.
SOURCE Volcano Corporation
