Volcano Corporation Announces 510(k) Clearance, CE Mark Approval, and First Clinical Use for the PrimeWire PRESTIGE(TM) Pressure Guide Wire
"The first PrimeWire PRESTIGE™ Pressure Guide Wire cases underline our commitment to delivering innovation and choice to our customers and patients," said Scott Huennekens, President and CEO of Volcano Corporation. "Our goal is to provide simple, easy-to-use products that address the complex challenges, like multi-vessel disease, that clinicians encounter each day. Multiple blockages usually have more tortuous tissue to navigate through, take longer to address, and may require more devices passing over-the-wire to deliver treatment. The PrimeWire PRESTIGE™ is an advanced wire designed to help guide multi-vessel disease decision-making."
"The clinical data from the FAME study supporting the use of FFR to guide stent placement in multi-vessel disease patients is very strong, and has led to the upgrade of ACC/AHA/SCAI guidelines to level of evidence A," commented Dr. Mort Kern, Chief of Cardiology for the VA Long Beach Health System and Associate Chief of Cardiology at UC-Irvine Medical Center. "One key hurdle that physicians continuously battle with is the accurate and efficient diagnosis of lesion significance at the time of the procedure. Any improvement to the performance of today's FFR wires that make assessment of multi-vessel disease lesions easier and faster is a welcome change to physicians."
The PrimeWire PRESTIGE™ Pressure Guide Wire has a redesigned core intended to improve mechanical performance, such as torque transmission, vessel navigation, and support. A recent internal study confirmed that PRESTIGE™ substantially outperformed the previous generation PrimeWire® with respect to torque transmission. The redesigned tip also improves tactile feel and tip shape memory. PrimeWire PRESTIGE™ will launch simultaneously with the new upgraded v3.2 Software for the Volcano s5i, which provides an optimized FFR workflow for ease of use.
CE Mark approval allows Volcano to market PrimeWire PRESTIGE™ in certain international markets, primarily in Europe. Volcano also has 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market PrimeWire PRESTIGE™ in the U.S.
"The PrimeWire PRESTIGE™ represents a significant improvement in performance to the previous generation FFR wire," commented Dr. Hoang Thai, Director, Cardiac Catheterization Laboratory and Interventional Cardiology, Southern Arizona Veterans' Affairs Health Care System Medical Center and Associate Director, Interventional Cardiology Fellowship Program Sarver Heart Center, University of Arizona. "I have been committed to using FFR in these complex patients for some time, and it is great to see a product evolving along with my practice to make my decision-making in the cath lab easier and more predictable."
About Volcano's Physiology Products
Volcano offers the broadest physiology product portfolio available today, which includes pressure and Doppler flow wires designed to deliver FFR, Coronary Flow Reserve (CFR) or both measurements simultaneously on the same wire. Volcano's s5i system, the only multi-modality system on the market, offers clinicians a choice of five modalities for assessment of lesion morphology and severity on a single platform: digital IVUS for fast plug and play imaging, high-frequency rotational IVUS for higher resolution, VH® IVUS for plaque characterization, ChromaFlo® for imaging blood flow, and FFR for physiological lesion assessment.
About Compatibility with Hemodynamic Monitoring Systems
Volcano's Smart Map® Pressure Instrument, PrimeWire® Pressure Guide Wire and PrimeWire PRESTIGE™ Pressure Guide Wire are now compatible with the majority of hemodynamic monitoring systems, making the benefits of FFR accessible to more clinicians and patients. Volcano's SmartMap® will provide a pressure reading to GE Healthcare's Mac-Lab® XT and XTi hemodynamic recording systems version 6.8.1, Siemens' AXIOM Sensis XP VC11, McKesson's Horizon Cardiology™ Hemo version 12.1, and Mennen's Horizon XVu Hemodynamic Monitoring System. With the pressure measurement derived from Volcano's family of PrimeWire® products, hemodynamic monitoring systems have the ability to calculate the FFR gradient and display the FFR measurement on the hemodynamic screen in the cath lab.
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, results and implications of the data from the FAME trial, 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.