Volcano receives CE mark for iFR Scout Pullback software to help diagnose serial lesions and diffuse coronary disease
AMSTERDAM and SAN DIEGO, March 12, 2015 /PRNewswire/ -- Royal Philips (NYSE: PHG; AEX: PHIA), today announced that Volcano, a Philips business, has received CE Mark for the iFR Scout pullback software, a functional extension of its existing iFR Modality, optimized to assess serial lesions and diffuse coronary disease. Limited Market Release will commence immediately at leading European and Japanese medical centers. This software is currently pending 510(k) clearance at the US FDA. It is not available for sale in the US.
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The iFR Modality is a physiologic measurement performed using the same Volcano pressure measurement guide wires and equipment used by catheterization labs for Fractional Flow Reserve (FFR), but it avoids the administration of hyperemic agents into the patient that induce stress to the heart to increase blood flow. This allows for a meaningful, lesion-specific assessment in seconds by amplifying the signal at rest. The iFR Modality is currently installed on over 2,000 systems worldwide.
Physicians have historically used a pressure wire pullback technique with FFR, under hyperemic conditions, to assess the type of underlying disease severity, whether focal or diffuse, to help determine the appropriate treatment for the patient. With the iFR Scout pullback software, this same functionality to 'scout out' the most treatable lesions will now be available without the administration of a hyperemic agent, thereby potentially reducing procedural time and cost to the facility, as well as improving patient comfort.
"Up to now, many operators felt uncomfortable in the frequent scenario of FFR interrogation in vessels with more than one stenosis, as interpretation is more difficult, and intravenous infusion is mandatory for FFR pullbacks," stated Dr. Javier Escaned, Consultant Interventional Cardiologist at Hospital Clinico San Carlos, Madrid, Spain. "The great attractiveness of iFR pullback is that resting flow is much more constant, and stable in these cases, allowing for more predictable interpretation of results. Further, we will now be able to conduct pullback without the need for administration of hyperemic agents. This may contribute to a wider adoption of physiological vessel mapping and, therefore, to a better, tailored treatment of patients with multiple coronary stenoses."
"The iFR Scout release represents another innovative step forward in making coronary physiology faster, and simpler, so that more patients worldwide can benefit from the value that physiology-guided treatment brings over angiography alone," commented Joe Burnett, General Manager Image Guided Therapy Devices at Volcano, a Philips business. "Globally, more than 2,000 systems have been activated with iFR, truly surpassing our expectations for adoption of this novel technology. Our teams are very excited to bring the iFR Scout capability to institutions so that clinicians can see first-hand the value that physiologic pullback provides in helping guide appropriate treatment to patients with serial stenoses, diffuse disease and other challenging clinical scenarios."
For further information, please contact:
Jacquie Keller
Media Relations, Volcano
Tel: +1 858-720-4142
Email: jkeller@Volcanocorp.com
Steve Klink Philips Group Communications
Tel.: +31 6 1088 8824
E-mail: steve.klink@philips.com
About Royal Philips
Royal Philips (NYSE: PHG, AEX: PHIA) is a diversified health and well-being company, focused on improving people's lives through meaningful innovation in the areas of Healthcare, Consumer Lifestyle and Lighting. Headquartered in the Netherlands, Philips posted 2014 sales of EUR 21.4 billion and employs approximately 105,000 employees with sales and services in more than 100 countries. The company is a leader in cardiac care, acute care and home healthcare, energy efficient lighting solutions and new lighting applications, as well as male shaving and grooming and oral healthcare. News from Philips is located at www.philips.com/newscenter.
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