Terumo Wins FDA Clearance for OPUSWAVE Dual Sensor Imaging System

Terumo Interventional Systems (TIS) has received US FDA 510(k) clearance for its OPUSWAVE dual sensor imaging system and its DualView imaging catheter, marking the company’s entry into the US cardiovascular imaging market. Designed for comprehensive evaluation of coronary artery disease (CAD), OPUSWAVE integrates intravascular ultrasound (IVUS) and optical frequency domain imaging (OFDI) to deliver simultaneous, high-resolution vessel views. The DualView catheter features a 150mm pullback capability, 2.6 French profile, hydrophilic coating, and variable pullback speeds of up to 40mm/s. By merging two imaging modalities in one catheter, the system enhances procedural efficiency, reduces time and cost, and improves precision in image-guided percutaneous coronary interventions (PCI). Terumo’s new platform offers interventional cardiologists greater flexibility to assess complex lesion morphologies and optimise treatment outcomes.

28-10-2025