The procedure, performed by Dr. Annapoorna S. Kini, took place on June 15 at Mount Sinai Fuster Heart Hospital in New York. Somerset, New Jersey-based Terumo Interventional says it marks a “significant milestone” for intravascular imaging as it enters the U.S. market.
OpusWave features the DualView imaging catheter, which offers a 150 mm maximum pullback length with a 2.6 Fr imaging profile. The catheter also offers 6 Fr guide compatibility and advanced hydrophilic coating. It has a variable pullback speed of up to 40 mm per second in dual mode.
The platform combines optical frequency domain imaging (OFDI) and intravascular ultrasound (IVUS). It aims to enable simultaneous views so physicians can comprehensively evaluate coronary artery disease (CAD). The company says that bringing both modalities to a single catheter helps physicians assess lesion morphology, plaque composition and stent deployment through a single platform.
Terumo Interventional earned FDA 510(k) clearance for the OpusWave system in October 2025.
Commentary from Terumo Interventional leadership and physicians
Gray Fleming, SVP, sales & marketing, Terumo Interventional Systems – U.S., said:
“The OpusWave imaging system enables physicians to see the full picture. From vessel structure to surface detail, physicians can act with greater certainty. That’s the promise of dual view – brought together into a single, clear answer.”
Dr. Michael J. Martinelli, chief medical officer, Terumo Medical, said:
“In the past, Interventional cardiologists have had to choose between two different imaging approaches. The OpusWave imaging system eliminates that tradeoff by providing both IVUS and OFDI imaging in a single catheter, providing the physician the opportunity to leverage the strengths of each modality simultaneously. This provides the physician with increased clarity and insight for more informed decision–making in real-time, leading to greater confidence when treating the individual patient.”
Dr. Kini added:
“Having both IVUS and OFDI available simultaneously changes how we approach complex cases. Instead of choosing between depth or resolution, we can see both at once – giving us a more complete understanding of the vessel and greater confidence in our decisions.”
