Terumo Interventional Systems announced today that it received FDA 510(k) clearance for its OpusWave dual-sensor imaging system.
OpusWave features the DualView imaging catheter, which received FDA 510(k) clearance alongside the entire system. The platform combines optical frequency domain imaging (OFDI) and intravascular ultrasound (IVUS). It aims to enable simultaneous veiws so physicians can comprehensively evaluate coronary artery disease (CAD).
Terumo said the clearance marks its imaging debut in the U.S. market, adding to its established presence in Japan.
“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, Terumo Interventional Systems. “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.”
Terumo says the DualView imaging catheter makes OpusWave unique. It 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.
This marks the latest positive development for Terumo Interventional. This year, the company also launched a new carotid stent following FDA approval.
“The OpusWave imaging system is an ideal technology for interventional cardiologists who perform image-guided PCI,” said Dr. Michael J. Martinelli, chief medical officer, Terumo Medical Corporation. “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.”
