FDA OKs Terumo’s Dual Sensor Imaging System and Imaging Catheter

Terumo Interventional Systems (TIS), a division of Terumo Corp., earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its Opuswave dual sensor imaging system. The system features the Dualiew imaging catheter, which also gained an FDA nod.

Opuswave merges optical frequency domain imaging (OFDI) and intravascular ultrasound (IVUS) to allow simultaneous views, giving physicians the ability to comprehensively evaluate coronary artery disease (CAD). Terumo is already a leader in Japan’s single modality imaging space and this marks the company’s imaging debut in the U.S. market.

The DualView imaging catheter has a 150 mm maximum pullback length. It also has a 2.6 Fr imaging profile, 6 Fr guide compatibility, advanced hydrophilic coating, and a variable pullback speed of up to 40 mm/sec in dual mode.

“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 OPUSWAVE Imaging System also creates a strong opportunity to shorten procedural time and costs in treating CAD.”

Michael J. Martinelli, MD, FACC, FSCAI and chief medical officer of Terumo Medical Corporation said Opuswave is ideal for interventional cardiologists who perform image-guided percutaneous coronary intervention (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,” said Dr. Martinelli. “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, Terumo began a $1.5 billion deal to acquire OrganOx, an Oxford-based company specializing in liver perfusion technology