Terumo's OPUSWAVE Dual Sensor Imaging System Receives FDA 510(k) Clearance for Coronary Artery Disease Treatment
Key Insights
Terumo Interventional Systems (search) received FDA 510(k) clearance for its OPUSWAVE Dual Sensor Imaging System (search), combining OFDI and IVUS technologies into a single catheter for coronary artery disease (search) evaluation.
The DualView imaging catheter (search) features a 150mm maximum pullback length, 2.6 Fr. imaging profile, and variable pullback speed up to 40mm/second in dual mode.
The system offers significant potential to reduce procedural time and costs while providing comprehensive imaging capabilities for interventional cardiologists performing image-guided PCI procedures.
Terumo Interventional Systems (search) (TIS), a division of Terumo Corporation, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its OPUSWAVE® Dual Sensor Imaging System and DualView® imaging catheter. The innovative system combines Optical Frequency Domain Imaging (OFDI) and intravascular ultrasound (IVUS) technologies into a single catheter, enabling simultaneous views for comprehensive evaluation of coronary artery disease (search) (CAD).
Revolutionary Dual-Modality Technology
The OPUSWAVE Imaging System represents a significant advancement in interventional cardiology by integrating two complementary imaging modalities. "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 (search). "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."
Technical Specifications and Clinical Benefits
The DualView imaging catheter (search) offers several advanced technical features that distinguish it in the market. The catheter provides a 150mm maximum pullback length, a 2.6 Fr. imaging profile, and 6 Fr. guide compatibility. Additionally, it features an 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, MD, FACC, FSCAI and 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."
Market Entry and Strategic Positioning
This FDA clearance marks Terumo's imaging debut in the US market, though the company is already a recognized leader in the single modality imaging space in Japan, where adoption of imaging in percutaneous coronary intervention (PCI) procedures is the highest in the world. The entry into the US market represents a significant expansion of Terumo's interventional cardiology portfolio.
Company Background
Terumo Interventional Systems (search) is a market leader in minimally invasive entry site management, lesion access, and therapeutic intervention. The division offers a comprehensive, solution-based product portfolio used in advanced coronary, peripheral and endovascular treatments with strategic initiatives in Transradial Access, Complex Coronary Intervention, Peripheral Artery Disease and Embolotherapy.
Terumo Corporation, founded in Tokyo in 1921, is a global medical innovation company that provides comprehensive solutions in therapeutic procedures, hospital operations, and life sciences across more than 160 countries and regions. The company operates under the Group Mission of "Contributing to Society through Healthcare."