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.