The US Food and Drug Administration (FDA) has granted 510(k) clearance to Terumo Interventional Systems’ (TIS) OPUSWAVE dual sensor imaging system, marking the company’s entry into the American imaging market.
The system’s DualView imaging catheter has also received 510(k) clearance from the US regulator.
Designed to provide a comprehensive assessment of coronary artery disease (CAD), the OPUSWAVE system merges intravascular ultrasound (IVUS) and optical frequency domain imaging (OFDI), allowing for concurrent views.
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The imaging catheter is characterised by its extended 150mm pullback capacity and a compact 2.6 French (Fr) profile.
It is designed to be compatible with 6Fr guides and features a hydrophilic coating. Additionally, the catheter also allows for variable pullback speeds, which can reach up to 40mm/s in its dual mode operation.
TIS president Ghada Farah said: “Importantly, the OPUSWAVE imaging system allows physicians to maximise imaging efficiency without sacrificing quality when it comes to creating treatment plans to achieve the best outcomes for their patients.
“By combining the advanced imaging capabilities of OFDI and IVUS into a single catheter, the OPUSWAVE imaging system also creates a strong opportunity to shorten procedural time and costs in treating CAD.”
The portfolio of TIS, a Terumo Corporation division, includes a variety of products tailored for coronary, peripheral, and endovascular treatments.
Terumo Medical Corporation chief medical officer Michael Martinelli said: “The OPUSWAVE imaging system is an ideal technology for interventional cardiologists who perform image-guided PCI.
“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.”
In August 2025, Terumo Corporation agreed to acquire OrganOx, a specialist in organ preservation devices, in a transaction estimated at $1.5bn.
