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Volcano Gets CE Mark for Lesion-Assessing Software

March 13, 2015

Volcano has received a CE mark for its iFR Scout pullback software, an extension of its existing iFR Modality, which assesses serial lesions and diffuses coronary disease. The software will launch immediately at leading European and Japanese medical centers, the Philips-owned company said Thursday.

iFR Modality is a physiologic measurement performed by using pressure measurement guide wires and equipment used by catheterization labs. It avoids administration of hyperemic agents that increase blood flow to the heart and gives a lesion-specific assessment in seconds by amplifying the signal at rest, Volcano said.

The iFR Scout software allows physicians to “scout out” the most treatable lesions without administering hyperemic agents, reducing procedure time and cost to the facility while improving patient comfort, the devicemaker said.

iFR Modality is currently installed on over 2,000 systems worldwide, Volcano said. It is awaiting 510(k) clearance in the U.S. — Kellen Owings