Terumo’s OPUSWAVE dual-sensor imaging system debuts in US.

USA—Terumo Interventional Systems (TIS) has announced the first clinical use of its OPUSWAVE Dual Sensor Imaging System in the United States, marking an important milestone in the adoption of the company’s next-generation intravascular imaging technology.

The inaugural procedure was performed on June 15 at Mount Sinai Fuster Heart Hospital in New York by interventional cardiologist Dr. Annapoorna S. Kini.

The achievement expands access to a technology designed to help physicians make more informed decisions during coronary interventions.

The OPUSWAVE Imaging System is built around Terumo’s DualView Imaging Catheter, which combines optical frequency-domain imaging (OFDI) and intravascular ultrasound (IVUS) on a single platform.

By integrating both imaging methods into a single catheter, the system provides simultaneous, complementary views of the coronary arteries, allowing physicians to evaluate blood vessels more comprehensively during procedures.

Dual Imaging in a Single Catheter

Traditionally, interventional cardiologists have relied on either IVUS or OFDI, with each technology offering different advantages.

IVUS delivers detailed images of deeper vessel structures, while OFDI provides high-resolution views of the vessel surface.

Terumo said the new platform eliminates the need to choose between the two by combining both capabilities into a single device.

Michael Martinelli, Chief Medical Officer at Terumo Medical Corporation, said the OPUSWAVE Imaging System allows physicians to leverage the strengths of both imaging techniques simultaneously.

According to him, the combined approach offers greater clarity and real-time insight, enabling clinicians to make more informed treatment decisions with increased confidence during complex coronary interventions.

Dr. Kini also highlighted the value of the technology, noting that having both imaging modalities available at the same time provides a more complete understanding of the coronary vessels.

She said the additional information can improve confidence when assessing complex cases and planning treatment strategies.

Designed for Flexibility and Workflow Efficiency

The DualView Imaging Catheter features a 2.6 French (Fr) profile, compatibility with 6 Fr guide catheters and a hydrophilic coating to improve deliverability through blood vessels.

It also offers a 150 mm pullback for both IVUS and OFDI, which Terumo says is the longest single-run pullback currently available for this type of technology.

Physicians can choose among IVUS-only, OFDI-only, or simultaneous dual-imaging modes, allowing them to tailor imaging to individual clinical needs while maintaining workflow efficiency.

The OPUSWAVE system received U.S. Food and Drug Administration (FDA) 510(k) clearance in late 2025 before entering clinical use this year.

Company Expands Its Imaging Portfolio

The first U.S. procedure follows Terumo’s broader efforts to strengthen its cardiovascular imaging business.

During its recent IR Day 2026 presentation, the company identified its dual-sensor system as a key growth platform and outlined plans to expand deployment beyond the United States into Japan and India as part of its long-term imaging strategy.

Terumo Interventional Systems develops minimally invasive technologies for coronary, peripheral and endovascular procedures, with strategic focus areas including transradial access, complex coronary interventions, peripheral artery disease and embolotherapy.