Volcano Corporation Announces Upcoming Presentation of Late-Breaking Clinical Trial Results and FFR Product Launch at TCT 2011
SAN DIEGO, CA. -- Volcano Corporation, a leading developer and manufacturer of precision guidance therapy tools designed to enhance the treatment of coronary and peripheral vascular disease, today announced that results from the ADVISE (ADenosine Vasodilator Independent Stenosis Evaluation) clinical trial, sponsored by Volcano, will be presented in a Late-Breaking Session at Transcatheter Cardiovascular Therapeutics (TCT 2011), which is taking place from November 7-11 in San Francisco .
Volcano also announced it is launching a new fractional flow reserve (FFR) pressure wire, the PrimeWire PRESTIGE™ PLUS, Volcano's newest FFR wire and the third pressure guidewire it has introduced in the last three years. It represents Volcano's latest advancement in its goal of delivering the precision of FFR guidance with the utility of a frontline guidewire.
Volcano will highlight its broad portfolio of Precision Guided Therapy products in clinical, educational and technology showcases throughout TCT 2011, including:
•Tuesday, November 8 at 7:00am-8:00am. Breakfast Symposium: Treating the Complex Lesion: Techniques and Technology for Left Mains and Bifurcations. Chair: David Rizik, MD; Faculty: John Hodgson, MD, Bon-Kwon Koo, MD. Moscone Convention Center, Room 114.
•Wednesday, November 9 at 10:00 am. Edited Taped Case Presentation: Development and Application of instant wave-Free Ratio (iFR): A New Pressure-Derived Adenosine-Free Measure of Fractional Flow Reserve: A First-in-Man Showcase. Operator: Justin Davies, MD, PhD. Presentation Theater North (Napa Valley), Moscone Center.
•Thursday, November 10 at 7:00am-8:00 am. Breakfast Symposium: Breaking Down Barriers to FFR. Adoption: Introducing iFR, a Vasodilator Independent Measure of Fractional Flow Reserve. Chair: Morton J. Kern, MD; Faculty: Justin Davies, MD, PhD, Javier Escaned, MD, PhD. Moscone Convention Center, Room 123.
•Friday, November 11 at 12:15 pm. Late-Breaking Results from the ADVISE Clinical Trial: Validation of a Vasodilator Independent Measure of Coronary Fractional Flow Reserve. Presenter: Justin Davies, MD, PhD. Main Arena III: Esplanade Ballroom
Precision Guided Therapy Leadership
FFR has become the gold standard for objective, lesion specific measurement of ischemia in the catheterization laboratory. FFR and IVUS are supported by ACC/AHA/ESC and SCAI guidelines, reimbursed under current CPT codes and are a reported metric in national registry quality reports for top hospitals across the country. FFR and IVUS-guided PCI continue to gain acceptance over angiography alone, yet they are used in less than 20 percent of procedures in the U.S.
Consistent with its cadence of innovation, Volcano is expanding its Functional Management offerings to include an investigational product called instant™ wave-Free Ratio or iFR™. In collaboration with physicians at Imperial College and Hospital Clinico San Carlos, Volcano is developing a technology with the objective of achieving FFR-like measurements without the use of Adenosine, a vasodilator injected to achieve maximum coronary flow, which can increase time, cost and complexity of the procedure, and cause patient discomfort. iFR is designed to provide a pharmaceutical-free means of assessing the functional performance of a discrete lesion as a measure of FFR.
In an effort to make the benefits of FFR accessible to more clinicians and patients, Volcano is working with suppliers of hemodynamic monitoring systems to provide FFR on their systems. Volcano's Smart Map Pressure Instrument is now compatible with the FFR module of the Philips Xper Flex Cardio Physiomonitoring System. This complements Volcano's current compatibility with 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.
"The healthcare environment is demanding more from physicians and hospitals to ensure that PCI therapy is performed only when appropriate, and only in patients for whom the benefit is proven," stated Scott Huennekens, President and CEO of Volcano Corporation. "Our FFR and IVUS technologies will help physicians, hospitals and payers quantify and document ischemia and disease severity in just minutes. Our goal is to make precision-guided PCI the new standard of care in an environment that demands both quality and cost efficiency."
Volcano will also highlight its currently available products and offering hands-on training sessions, including an FFR simulator in Booth #1317.
SOURCE: Volcano Corporation
Volcano Corporation Announces Upcoming Presentation of Late-Breaking Clinical Trial Results and FFR Product Launch at TCT 2011
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