First Intravascular Imaging System Combines Critically Important Imaging Technologies to Optimize Coronary Stent Placement

Intravascular imaging has become a vital tool to optimize coronary stenting procedures, providing key insights into plaque morphology, plaque modification decisions, stent and balloon sizing and landing zone selection, confirmation of treatment optimization and future adverse event risk. A novel intravascular imaging system now combines next-generation DeepOCT images and near infrared spectroscopy (NIRS) with state-of-the-art ease of use to support physicians optimizing coronary stenting in the cardiac catheterization lab.

The HyperVue system from SpectraWAVE, Inc. (Bedford, MA, USA) is the first to combine two critically important imaging technologies, DeepOCT and NIRS, while optimizing for image quality and procedural efficiency in the cath lab. The HyperVue Imaging System is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The NIRS capability of the system is intended for the identification of patients and plaques at increased risk of major adverse cardiac events.

The Starlight Imaging Catheter delivers rapid pullbacks of both imaging modalities in a single, low-profile, no-flush form factor. The physician controls both image acquisition and artificial intelligence-enabled image review from the sterile field, a workflow designed for simplicity when optimizing percutaneous coronary intervention (PCI). SpectraWAVE has received Food and Drug Administration (FDA) 510(k) clearance for the HyperVue intravascular imaging system which has now been used by multiple physicians as part of a first-in-human study.

“This is a landmark day for SpectraWAVE, but more importantly, a critical step towards improving outcomes for patients with coronary artery disease,” said Eman Namati, Ph.D., Chief Executive Officer of SpectraWAVE. “Our proprietary DeepOCT-NIRS imaging system pushes the technological limits of optical coherence tomography - both in image quality and depth -while combining it with spectroscopy for the first time, packaging both into a no-flush catheter with an artificial intelligence-powered user experience. With this regulatory clearance, we are excited to begin the transition to a commercial entity and launch our product.”

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SpectraWAVE, Inc.