AMSTERDAM and SAN DIEGO, March 12,
2015 /CNW/ -- 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.
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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SOURCE Royal Philips