Volcano to Present Clinical Trial Results, FFR Product Launch at TCT 2011

 

November 9, 2011

November 9, 2011 — Volcano Corp. announced results from the ADVISE (ADenosine Vasodilator Independent Stenosis Evaluation) clinical trial will be presented in a Late-Breaking Session at Transcatheter Cardiovascular Therapeutics (TCT) 2011. The event is taking place from Nov. 7-11 in San Francisco.

Volcano also announced it is launching a new fractional flow reserve (FFR) pressure wire, the PrimeWire Prestige Plus. It is the third pressure guidewire the company has introduced in the last three years.

The company will highlight its portfolio of precision guided therapy products in clinical, educational and technology showcases throughout TCT 2011, including:

  • Wednesday, Nov. 9: 10:00 a.m.
    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
    Presentation Theater North (Napa Valley), Moscone Center
    Operator: Justin Davies, M.D., Ph.D.
  • Thursday, Nov. 10: 7:00 - 8:00 a.m.
    Breakfast Symposium - Breaking Down Barriers to FFR
    Adoption: Introducing iFR, a Vasodilator Independent Measure of Fractional Flow Reserve
    Moscone Convention Center, Room 123
    Chair: Morton J. Kern, M.D.; Faculty: Justin Davies, M.D., Ph.D., Javier Escaned, M.D., Ph.D.
  • Friday, Nov. 11: 12:15 p.m.
    Late-Breaking Results from the ADVISE Clinical Trial: Validation of a Vasodilator Independent Measure of Coronary Fractional Flow Reserve
    Main Arena III: Esplanade Ballroom
    Presenter: Justin Davies, M.D., Ph.D.

FFR has become the gold standard for objective, lesion-specific measurement of ischemia in the catheterization laboratory. FFR and intravascular ultrasound (IVUS) are supported by joint American College of Cardiology (ACC)/American Heart Association (AHA)/European Society of Cardiology (ESC) and Society for Cardiac Angiography and Interventions (SCAI) guidelines.

Both procedures are 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 percutaneous coronary interventions (PCI) continue to gain acceptance over angiography alone, yet they are used in less than 20 percent of procedures in the United States.

Volcano is expanding its functional management offerings to include an investigational product called instant wave-free ratio or iFR. The company is collaborating with physicians at Imperial College and Hospital Clinico San Carlos to develop a technology with the objective of achieving FFR-like measurements without the use of adenosine. The compound in question is 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. The 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.

For more information: www.volcanocorp.com