Volcano, a Royal Philips business, has secured CE Mark approval for its iFR Scout pullback software, a functional extension of its existing iFR Modality, designed to diagnose serial lesions and diffuse coronary disease.
The new software is pending 510(k) clearance at US Food and Drug Administration (FDA) and is not available for sale in the US.
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Volcano is planning to initiate limited market release of the software at leading European and Japanese medical centres.
The iFR Modality is a physiological measurement conducted using Volcano’s pressure measurement guide wires and equipment used by catheterisation labs for fractional flow reserve (FFR).
The company said it avoids administration of hyperemic agents into the patient that induce stress to the heart to increase blood flow.
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Installed on more than 2,000 systems worldwide, iFR Modality provides lesion-specific assessment in seconds by amplifying the signal at rest.
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By GlobalDataHospital Clínico San Carlos consultant interventional cardiologist Dr Javier Escaned said: "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."
Under hyperemic conditions, physicians have used a pressure wire pullback technique with FFR to evaluate the type of underlying disease severity, whether focal or diffuse, to help determine appropriate treatment for the patient.
The same functionality is available with iFR Scout pullback software to look for the most treatable lesions without the administration of a hyperemic agent, reducing procedural time and costs.
