Terumo Interventional Systems (TIS), a part of Terumo Corporation, announced that the OPUSWAVE® Dual Sensor Imaging System and DualView® imaging catheter received U.S. FDA 510(k) clearance. The OPUSWAVE system combines Optical Frequency Domain Imaging (OFDI) with Intravascular Ultrasound (IVUS). This lets doctors image at the same time. They get a full view of coronary artery disease (CAD).
This is Terumo’s first imaging launch in the U.S. They have a strong presence in Japan. There, imaging for PCI procedures ranks among the highest globally. The DualView catheter features a 150mm maximum pullback length, a 2.6 Fr. imaging profile, 6 Fr. guide compatibility, and a variable pullback speed up to 40mm/second, enhanced with an advanced hydrophilic coating.
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The OPUSWAVE system’s dual-modality imaging allows for superior lesion visualization, supporting more precise diagnosis and treatment planning for complex coronary cases.

