Netherlands-based Royal Philips business Volcano has obtained CE mark approval for its iFR Scout pullback software.
The new software, which was a functional extension to its existing iFR Modality, has been developed to diagnose serial lesions and diffuse coronary disease.
According to Philips, the software is currently pending 510(k) approval at the US Food and Drug administration.
Volcano image guided therapy devices general manager Joe Burnett said: “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.
“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.”
The iFR Modality is a physiologic measurement that is carried out using the Volcano pressure measurement guide wires and equipment. It avoids the administration of hyperemic agents into the patient that induce stress to the heart to increase blood flow.
Currently installed on around 2,000 systems across the globe, the iFR Modality provides lesion-specific assessment in seconds by amplifying the signal at rest.
Under hyperemic conditions, physicians have used a pressure wire pullback technique with Fractional Flow Reserve (FFR) to uate the type of underlying disease severity, whether focal or diffuse, to help determine the appropriate treatment for the patient.
The same functionality is available with the iFR Scout pullback software to look out the most treatable lesions without the administration of a hyperemic agent, reducing procedural time and cost to the facility.
Philips has announced plans of immediate limited market release of the new software at leading European and Japanese medical centers.