New York cardiologist performs first procedure in US with FDA-cleared imaging tech
Terumo Interventional Systems, a New Jersey-based division of Terumo, announced that its OpusWave Dual Sensor Imaging System has been used to treat a U.S. patient for the very first time.
The system’s DualView Imaging Catheter combines intravascular ultrasound (IVUS) and optical frequency domain imaging (OFDI) into a single platform, providing users with two complementary views of the coronaries at the same time. IVUS-only and OFDI-only imaging options are also available if cardiologists only require a single view.
Cardiologist Annapoorna S. Kini, MD, director of the interventional structural heart disease program at Mount Sinai Fuster Heart Hospital, performed the historic procedure to evaluate a patient with suspected coronary artery disease.
“Having both IVUS and OFDI available simultaneously changes how we approach complex cases,” Kini, who also serves as the director of the hospital’s interventional cardiology fellowship program and Samin K. Sharma Family Foundation Cardiac Catheterization Lab, said in a statement. “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.”
“In the past, Interventional cardiologists have had to choose between two different imaging approaches,” added Michael J. Martinelli, MD, chief medical officer of Terumo Medical Corp. “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.”
FDA cleared imaging tech back in 2025
The OpusWave Dual Sensor Imaging System received U.S. Food and Drug Administration (FDA) clearance in October 2025.
“The OPUSWAVE Imaging System is an ideal technology for interventional cardiologists who perform image-guided PCI,” Martinelli said at the time.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.