Volcano wins CE Mark for new FFR software

Cardiovascular imaging company Volcano nailed down a CE Mark in the European Union for diagnostic software that helps assess serial lesions and diffuse coronary disease in a simpler way.

The San Diego, Calif. operation, snatched up for $1.2 billion by Dutch conglomerate Royal Philips (NYSE:PHG) last December, said it will begin a limited roll-out in Europe and Japan for its iFR Scout pullback software, an extension of its existing iFR Modality.

The iFR Modality device uses Volcano’s pressure measurement guidewires and equipment for fractional flow reserve measurement to gauge the extent of coronary artery narrowing in an attempt to predict heart attacks. The Volcano equipment with the new iFR Scout pullback software enables assessment of a patient at rest, rather than relying on hyperemic agents injected into the patient to induce stress/more blood flow in order to work.

"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," image-guided therapy devices general manager Joe Burnett said in prepared remarks. "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.”

Philips agreed in December to pay $1.2 billion for Volcano, paying a 56.7% premium over VOLC’s $11.49 closing price the day before the deal was announced. The deal added Volcano’s intravascular ultrasound and fractional flow reserve technologies to Philips’ portfolio of interventional imaging equipment.