Somerset, N.J. — October 24, 2025 (cGxP.wire) — Terumo Interventional Systems (TIS), a division of Terumo Corporation, announced today that it has received U.S. FDA 510(k) clearance for its OPUSWAVE® Dual Sensor Imaging System, marking a significant milestone in coronary imaging technology. The clearance also covers the accompanying DualView® imaging catheter, which enables simultaneous imaging through both Optical Frequency Domain Imaging (OFDI) and Intravascular Ultrasound (IVUS) — a first-of-its-kind integration designed to improve precision and efficiency in diagnosing and treating coronary artery disease (CAD). This approval represents Terumo’s official imaging debut in the U.S., strengthening its footprint in advanced interventional cardiology and reaffirming its global leadership in the imaging sector. Japan currently leads the world in imaging adoption during percutaneous coronary intervention (PCI) procedures, and Terumo’s success there has set the stage for its expansion into the U.S. cardiovascular device market.
Science Significance
The OPUSWAVE Imaging System represents a breakthrough in multimodal cardiovascular imaging technology. By combining OFDI and IVUS capabilities in one catheter, the device provides interventional cardiologists with a comprehensive view of vessel morphology, plaque characterization, and lesion structure. This integration allows for both high-resolution optical assessment and deep tissue penetration, enabling physicians to tailor PCI procedures with unmatched accuracy. The DualView® imaging catheter features a 150mm pullback length, a 2.6 Fr imaging profile, and 6 Fr guide compatibility, making it suitable for complex and tortuous vessels. Its variable pullback speed of up to 40mm per second supports real-time, high-speed dual imaging without compromising quality or safety. These design advancements help clinicians optimize treatment decisions, particularly in cases involving calcified or bifurcated lesions. According to Dr. Michael J. Martinelli, Chief Medical Officer at Terumo Medical Corporation, “The OPUSWAVE Imaging System provides the flexibility to use both OFDI and IVUS modalities through a single catheter, removing the need to commit to one imaging technology. This innovation enables deeper, more accurate visualization across a range of lesion morphologies.”
Regulatory Significance
The FDA’s 510(k) clearance for the OPUSWAVE system underscores the agency’s confidence in the device’s safety, reliability, and clinical performance. This clearance allows Terumo to immediately commercialize the technology in the United States, expanding access to advanced coronary imaging tools for interventional cardiologists nationwide. 510(k) clearance represents a pivotal regulatory milestone for any device manufacturer, as it validates substantial equivalence to predicate devices while permitting the introduction of next-generation functionality — in this case, the dual-sensor capability integrating OFDI and IVUS. For Terumo, this regulatory achievement marks the company’s first step into the U.S. intravascular imaging space, complementing its already established leadership in guidewires, catheters, and access systems.
Business Significance
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From a business standpoint, this clearance is strategically transformative for Terumo Interventional Systems. The U.S. market for intravascular imaging — estimated at over $1.2 billion annually and growing at double-digit rates — is dominated by single-modality devices. By introducing a dual-modality platform, Terumo positions itself to capture significant market share from competitors in both the OFDI and IVUS segments. Ghada Farah, President of Terumo Interventional Systems, noted, “By combining the advanced imaging capabilities of OFDI and IVUS into a single catheter, the OPUSWAVE Imaging System creates a strong opportunity to shorten procedural time and reduce costs while improving outcomes.” The company’s U.S. launch strategy aligns with its broader global mission to deliver comprehensive endovascular solutions that merge clinical efficacy with economic value. The OPUSWAVE platform also serves as a cornerstone for Terumo’s long-term innovation roadmap, enabling integration with digital platforms and AI-assisted analysis in future iterations. This advancement complements Terumo’s other strategic initiatives in Transradial Access, Complex Coronary Intervention, and Embolotherapy, solidifying its position as a full-spectrum cardiovascular solutions provider.
Patients’ Significance
For patients with coronary artery disease — one of the world’s leading causes of morbidity and mortality — the OPUSWAVE Imaging System offers the promise of more precise, faster, and safer procedures. The ability to visualize both microstructural and macrostructural features of arterial lesions in real time can lead to more accurate stent placement, fewer complications, and potential reductions in procedural duration and contrast exposure. “The OPUSWAVE System allows physicians to maximize imaging efficiency without sacrificing quality when creating treatment plans,” added Farah. These benefits align directly with the growing emphasis on value-based healthcare, where improved clinical outcomes and procedural efficiency drive both patient and institutional success. By reducing the need for multiple imaging tools, the OPUSWAVE platform minimizes procedural disruptions, contributing to better patient experiences and faster recoveries. The system’s hydrophilic coating and small catheter profile also support less invasive interventions, particularly beneficial for patients at higher risk of vascular complications.
Policy Significance
The FDA’s clearance of the OPUSWAVE Imaging System reinforces the regulatory agency’s commitment to fostering innovation in medical imaging and interventional cardiology. It also aligns with broader U.S. healthcare priorities — including expanding access to minimally invasive cardiovascular technologies and reducing overall treatment costs through efficiency gains. In the context of public health, this approval supports the ongoing transition toward precision interventional medicine, where advanced diagnostic tools enable earlier detection and tailored therapeutic strategies. Moreover, it reflects global regulatory trends emphasizing multi-functional medical devices that enhance patient safety, procedural efficiency, and interoperability with hospital digital infrastructure.
Transaction Highlights
Terumo Interventional Systems (TIS) has received FDA 510(k) clearance for its OPUSWAVE® Dual Sensor Imaging System and DualView® imaging catheter, marking the company’s entry into the U.S. intravascular imaging market. The OPUSWAVE system integrates Optical Frequency Domain Imaging (OFDI) and Intravascular Ultrasound (IVUS) into a single catheter, enabling simultaneous, high-resolution visualization of coronary artery disease. Featuring a 150 mm pullback length, 2.6 Fr. profile, and variable pullback speed up to 40 mm/s, the DualView catheter enhances diagnostic precision and procedural efficiency. This innovation is expected to reduce procedural time and cost, while improving workflow and clinical outcomes in image-guided PCI procedures, reinforcing Terumo’s global leadership in interventional cardiology imaging technologies.
Source: Terumo Interventional Systems Press Release
