Terumo Interventional Systems has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its OpusWave dual-sensor imaging system, the company has announced.
The system, which features the DualView imaging catheter, combines optical frequency domain imaging (OFDI) and intravascular ultrasound (IVUS) to enable simultaneous views and the ability to comprehensively evaluate coronary artery disease (CAD).
The clearance marks Terumo’s imaging debut in the US market, having already entered the single-modality imaging space in Japan, Terumo said in a press release.
“Importantly, 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,” said Ghada Farah, president of Terumo Interventional Systems. “By combining the advanced imaging capabilities of OFDI and IVUS into a single catheter, the [system] also creates a strong opportunity to shorten procedural time and costs in treating CAD.”
The DualView catheter offers a 150mm maximum pullback length, a 2.6Fr imaging profile, 6Fr guide compatibility, advanced hydrophilic coating, and a variable pullback speed of up to 40mm/second in dual mode.
“The OpusWave imaging system is an ideal technology for interventional cardiologists who perform image-guided PCI,” said Michael J Martinelli, Terumo chief medical officer. “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.”
