CE Mark for Software to Help Diagnose Serial Lesions and Diffuse Coronary Disease

Royal Philips has announced that Volcano, a business it acquired late last year, has received CE Mark for the iFR Scout pullback software. This is a functional extension of its existing iFR Modality, optimized to assess serial lesions and diffuse coronary disease.

Background 

Physicians have historically used a pressure wire pullback technique with Fractional Flow Reserve (FFR), under hyperemic conditions, to assess the type of underlying coronary disease severity. This helps to 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.

The iFR Modality is a physiologic measurement performed using the same Volcano pressure measurement guide wires and equipment used by catheterization labs for FFR. Significantly though, 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, and with this new CE mark, the company will be undertaking a limited market release at leading European and Japanese medical centers. This software is currently pending U.S. FDA 510(k) clearance and remains unavailable for sale in the US.

Physician comments

“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.”

Company comments

“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.”

Source: PR Newswire

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