Terumo Interventional Systems, which is part of Terumo Corporation, has been approved by the FDA for its OPUSWAVE Dual Sensor Imaging System, along with its DualView imaging catheter. This approval, known as 510(k) clearance, means the system is now ready for use in the U.S. The OPUSWAVE system uses both Optical Frequency Domain Imaging (OFDI) and intravascular ultrasound (IVUS) to create images at the same time. This lets doctors get a more complete view of coronary artery disease. This is Terumo’s first system that uses two imaging methods together in the U.S. However, the company has long been a leader in single-modality imaging in Japan, where imaging is commonly used during procedures to treat blocked arteries.

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Ghada Farah, President of Terumo Interventional Systems, said the OPUSWAVE system helps doctors get better images without affecting the quality of care. She explained that combining OFDI and IVUS in one catheter can save time, reduce costs, and help doctors plan better treatments for patients with coronary artery disease.

One of the key parts of the OPUSWAVE system is the DualView imaging catheter. It can pull back up to 150 millimeters, has a small size of 2.6 French, is compatible with 6 French guides, has a special coating that makes it easier to move through blood vessels, and can pull back at a speed of up to 40 millimeters per second in dual mode. These features help doctors get clear and efficient images for different types of blockages.

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Michael J. Martinelli, MD, FACC, FSCAI, and Chief Medical Officer of Terumo Medical Corporation, said the OPUSWAVE system is ideal for interventional cardiologists who perform PCI procedures with image guidance. He pointed out that it lets doctors use both OFDI and IVUS in one procedure, so they don’t have to choose between the two. This allows for a more detailed look at complex blockages.

With the FDA approval of the OPUSWAVE system and the DualView catheter, Terumo is looking to grow its presence in the U.S. imaging market. The system gives doctors a flexible and powerful tool to improve patient outcomes. It’s designed to make image-guided coronary procedures more efficient, accurate, and adaptable.

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