News | April 06, 2015

Volcano Receives CE Mark for iFR Scout Pullback Software

Extension of iFR Modality software helps diagnose serial lesions and diffuse coronary disease

iFR Scout, pullback software, iFR Modality, fractional flow reserve, FFR

iFR Modality screenshot courtesy of Volcano Corp.

April 6, 2015 — Royal Philips announced that Volcano, a Philips business, has received CE Mark for the iFR Scout pullback software. iFR Scout is a functional extension of its existing instant wave-Free Ratio (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 U.S. Food and Drug Administration (FDA), and is not available for sale in the U.S.

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.

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 Javier Escaned, M.D., 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."

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