SAN DIEGO, Feb. 9 /PRNewswire-FirstCall/ -- Volcano Corporation (Nasdaq: VOLC), a leading developer and manufacturer of precision intravascular therapy guidance tools designed to enhance the diagnosis and treatment of coronary and peripheral vascular disease, announced today that it has acquired the Xtract™ Thrombus Aspiration Catheter device line from Lumen Biomedical. Volcano became the exclusive global distributor of the Xtract™ catheter in May 2009. This acquisition reinforces Volcano's dedication 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 (AMI) or heart attacks.
The Xtract™ thrombus aspiration catheter supports the care of ST Segment Elevation Myocardial Infarction (STEMI). The main cause of heart attacks is a plaque rupture in one of the main coronary arteries. Plaque builds up in the arterial wall and ruptures, which can generate a blood clot or thrombus that blocks blood flow and deprives the heart muscle of oxygen. As long as the clot subsists, cells of the heart muscle will continue to die and worsen the patient's condition. The Xtract™ aspiration catheter, with its patented, large single lumen design, circular right-angle tip, and curved directional distal segment, delivers fast and powerful clot removal to help re-establish blood flow quickly. The product line includes two sizes, with the larger size model offering the largest aspiration lumen of any aspiration catheter, for effective and efficient clot extractions.
"Volcano is excited to fortify its commitment to be the leading and most-trusted partner for physicians when addressing patients with complex disease states that require thrombus aspiration," said Scott Huennekens, President and Chief Executive Officer of Volcano. "Since we began to distribute the Xtract™ catheter last year, it has been well-received by the interventional cardiology community. Consistent with our drive to continuously improve our product offerings, we now have control over the product and rights to the design, and will be able to directly build upon the feedback we have received from our customers on how to further improve upon our unique approach to thrombus aspiration."
As a result of the strength of recent clinical studies, a new recommendation acknowledging that the use of aspiration thrombectomy is reasonable to treat STEMI was a key change in the December 2009 update to the STEMI and percutaneous coronary intervention (PCI) guidelines. These guidelines for treating coronary disease and heart attacks using PCI were issued by the American Heart Association (AHA), the American College of Cardiology (ACC), and the Society for Cardiovascular Angiography and Interventions (SCAI). "There are three clinical studies cited in the guidelines – TAPAS, EXPIRA, and ATTEMPT - that clearly demonstrate the potential benefit of using aspiration thrombectomy in STEMI patients," said Dr. Matthew Price, Director of the Cardiac Catheterization Laboratory at Scripps Clinic and Director of Interventional Cardiology Research for Scripps Genomic Medicine. "In the TAPAS study, with aspiration versus PCI alone, there was a 46% reduction in cardiac death at 1 year. In the EXPIRA study, there was no cardiac death in the PCI only group versus 6.5% death at 2 years. In the ATTEMPT study, which was a large pooled analysis of randomized trials, there was a 34% reduction in mortality even with the use of IIb/IIa inhibitors. In addition to better clinical outcomes, these studies also showed better procedural results with respect to Myocardial Blush Grade and resolution of ST Segment Elevation Resolution."
"Aspiration has really been a game-changer with respect to how we treat a STEMI in the cath lab," continued Dr. Price. "Starting with aspiration rather than balloon angioplasty prevents distal embolization and reflow. Furthermore, by re-establishing blood flow beyond the initial clot, the rest of the vessel becomes visible so we can better diagnose the location and severity of the vessel blockage and optimize stent placement."
"Volcano could not be more pleased about the new recommendation from the ACC, AHA, and SCAI that aspiration thrombectomy, the procedure for which the Xtract™ device is uniquely designed, is reasonable in primary PCI for STEMI," noted Vince Burgess, Group President of Advanced Imaging Systems at Volcano. "This acquisition of the Xtract™ device line underscores how Volcano strives to be strategically ahead of the curve by providing physicians with the right technologies supported by the most impactful clinical data."
"Just like our previous acquisitions of CardioSpectra, Novelis, and Axsun, we are excited to add another innovative technology to the comprehensive suite of tools we are building to support physicians, regardless of how complex the disease state they address might be," added Burgess. "Although our core IVUS and FM products are used in both routine and complex clinical scenarios, Volcano is continuing to execute on our therapeutic strategy by investing in products and clinical studies aimed at procedures whose outcomes have the most room for improvement. These include AMI, CTO (Chronic Total Occlusion) and Bifurcation lesions. The acquisition of the Xtract™ product line is yet another example of our commitment to that strategy."
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 functional measurement (FM) 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 4,700 Volcano IVUS and FM systems are installed worldwide, and more than half of Volcano's revenues are derived 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 www.volcanocorp.com.
About Lumen Biomedical
Since being founded in July 2003, Lumen Biomedical's primary goal has been to create unique interventional devices that outperform existing technologies and can be used in virtually any anatomical area. With this goal in mind, the company has dedicated its efforts to developing and commercializing products for embolic protection and thrombus removal throughout the body. The company believes that the FiberNet® Embolic Protection System, which received FDA clearance in November 2008, will establish a new standard and confidence in embolic protection.
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, results and implications of the data from the referenced trials and studies, 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 reports 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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The Xtract™ thrombus aspiration catheter supports the care of ST Segment Elevation Myocardial Infarction (STEMI). The main cause of heart attacks is a plaque rupture in one of the main coronary arteries. Plaque builds up in the arterial wall and ruptures, which can generate a blood clot or thrombus that blocks blood flow and deprives the heart muscle of oxygen. As long as the clot subsists, cells of the heart muscle will continue to die and worsen the patient's condition. The Xtract™ aspiration catheter, with its patented, large single lumen design, circular right-angle tip, and curved directional distal segment, delivers fast and powerful clot removal to help re-establish blood flow quickly. The product line includes two sizes, with the larger size model offering the largest aspiration lumen of any aspiration catheter, for effective and efficient clot extractions.
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"Volcano is excited to fortify its commitment to be the leading and most-trusted partner for physicians when addressing patients with complex disease states that require thrombus aspiration," said Scott Huennekens, President and Chief Executive Officer of Volcano. "Since we began to distribute the Xtract™ catheter last year, it has been well-received by the interventional cardiology community. Consistent with our drive to continuously improve our product offerings, we now have control over the product and rights to the design, and will be able to directly build upon the feedback we have received from our customers on how to further improve upon our unique approach to thrombus aspiration."
As a result of the strength of recent clinical studies, a new recommendation acknowledging that the use of aspiration thrombectomy is reasonable to treat STEMI was a key change in the December 2009 update to the STEMI and percutaneous coronary intervention (PCI) guidelines. These guidelines for treating coronary disease and heart attacks using PCI were issued by the American Heart Association (AHA), the American College of Cardiology (ACC), and the Society for Cardiovascular Angiography and Interventions (SCAI). "There are three clinical studies cited in the guidelines – TAPAS, EXPIRA, and ATTEMPT - that clearly demonstrate the potential benefit of using aspiration thrombectomy in STEMI patients," said Dr. Matthew Price, Director of the Cardiac Catheterization Laboratory at Scripps Clinic and Director of Interventional Cardiology Research for Scripps Genomic Medicine. "In the TAPAS study, with aspiration versus PCI alone, there was a 46% reduction in cardiac death at 1 year. In the EXPIRA study, there was no cardiac death in the PCI only group versus 6.5% death at 2 years. In the ATTEMPT study, which was a large pooled analysis of randomized trials, there was a 34% reduction in mortality even with the use of IIb/IIa inhibitors. In addition to better clinical outcomes, these studies also showed better procedural results with respect to Myocardial Blush Grade and resolution of ST Segment Elevation Resolution."
"Aspiration has really been a game-changer with respect to how we treat a STEMI in the cath lab," continued Dr. Price. "Starting with aspiration rather than balloon angioplasty prevents distal embolization and reflow. Furthermore, by re-establishing blood flow beyond the initial clot, the rest of the vessel becomes visible so we can better diagnose the location and severity of the vessel blockage and optimize stent placement."
"Volcano could not be more pleased about the new recommendation from the ACC, AHA, and SCAI that aspiration thrombectomy, the procedure for which the Xtract™ device is uniquely designed, is reasonable in primary PCI for STEMI," noted Vince Burgess, Group President of Advanced Imaging Systems at Volcano. "This acquisition of the Xtract™ device line underscores how Volcano strives to be strategically ahead of the curve by providing physicians with the right technologies supported by the most impactful clinical data."
"Just like our previous acquisitions of CardioSpectra, Novelis, and Axsun, we are excited to add another innovative technology to the comprehensive suite of tools we are building to support physicians, regardless of how complex the disease state they address might be," added Burgess. "Although our core IVUS and FM products are used in both routine and complex clinical scenarios, Volcano is continuing to execute on our therapeutic strategy by investing in products and clinical studies aimed at procedures whose outcomes have the most room for improvement. These include AMI, CTO (Chronic Total Occlusion) and Bifurcation lesions. The acquisition of the Xtract™ product line is yet another example of our commitment to that strategy."
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 functional measurement (FM) 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 4,700 Volcano IVUS and FM systems are installed worldwide, and more than half of Volcano's revenues are derived 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 www.volcanocorp.com.
About Lumen Biomedical
Since being founded in July 2003, Lumen Biomedical's primary goal has been to create unique interventional devices that outperform existing technologies and can be used in virtually any anatomical area. With this goal in mind, the company has dedicated its efforts to developing and commercializing products for embolic protection and thrombus removal throughout the body. The company believes that the FiberNet® Embolic Protection System, which received FDA clearance in November 2008, will establish a new standard and confidence in embolic protection.
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, results and implications of the data from the referenced trials and studies, 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 reports 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
