Terumo's OPUSWAVE® Imaging System Receives FDA 510(k) Clearance to Transform Cardiac Procedures

Terumo Interventional Systems Unveils OPUSWAVE® Dual Sensor Imaging System

On October 24, 2025, Terumo Interventional Systems (TIS) announced an exciting milestone in the field of medical imaging, specifically within interventional cardiology. The company received FDA 510(k) clearance for its latest innovation, the OPUSWAVE® Dual Sensor Imaging System, along with its complementary DualView® imaging catheter. These groundbreaking advancements promise to reshape how physicians approach and manage coronary artery disease (CAD).

A New Era in Cardiac Imaging

The OPUSWAVE Imaging System stands out by integrating Optical Frequency Domain Imaging (OFDI) and intravascular ultrasound (IVUS) into a single catheter. This dual modality offers significant benefits, allowing physicians to conduct simultaneous evaluations during coronary interventions effectively. By providing clearer and more comprehensive views, the OPUSWAVE system is a game changer in the quest for efficient and precise coronary artery treatments.

According to Ghada Farah, President of Terumo Interventional Systems, "The OPUSWAVE Imaging System allows physicians to maximize imaging efficiency without sacrificing quality when it comes to creating treatment plans to achieve the best outcomes for their patients." This system aims to streamline procedures involved in percutaneous coronary interventions (PCIs), reducing both time and costs, making it a vital tool for interventional cardiologists.

Unique Features of the OPUSWAVE Imaging System

Central to the OPUSWAVE system is its DualView imaging catheter, which boasts an impressive maximum pullback length of 150mm. With a slim 2.6 Fr. imaging profile, this advanced catheter is compatible with a 6 Fr. guide and features an innovative hydrophilic coating that enhances its performance. Notably, it provides a variable pullback speed of up to 40mm/second in dual mode, allowing for greater flexibility during procedures.

Dr. Michael J. Martinelli, Chief Medical Officer at Terumo Medical Corporation, highlighted the unique benefits of the OPUSWAVE Imaging System: "This innovative imaging system provides the opportunity for physicians to take advantage of the benefits of both OFDI and IVUS in the assessment and treatment of any lesion morphology. Instead of having to commit to one imaging tool, they now have the flexibility to access both imaging modalities with a single catheter."

Terumo’s Legacy in Medical Innovation

While the OPUSWAVE Imaging System marks Terumo's inaugural entry into the imaging market in the United States, the company is no stranger to medical advancements. In Japan, Terumo has long been a leader in single modality imaging, particularly within PCI procedures. This history positions TIS well as it endeavors to expand its portfolio and pave the way for innovative solutions in cardiovascular care.

PAC interventions are crucial for many patients suffering from CAD, and the OPUSWAVE Imaging System is tailored to provide interventional cardiologists with tools that enhance precision. As the demand for efficient, cost-effective solutions increases, TIS is committed to delivering transformative products that improve patient care outcomes.

Conclusion

The FDA's clearance for the OPUSWAVE® Imaging System and its complementary imaging catheter represents a significant advancement in medical technology. This system not only promises to enhance procedural efficiency but also aims to redefine standards of care in treating coronary artery disease. By merging advanced imaging technology, Terumo Interventional Systems is paving the way for a brighter future in interventional cardiology, ensuring that physicians are equipped with the best tools to improve patient outcomes and provide care that is both innovative and effective. The launch of the OPUSWAVE system marks a collaborative step towards a new era in cardiac imaging and patient management.

For more information about Terumo Interventional Systems and its product offerings, visit their official website at www.terumois.com.