SpectraWAVE Gains Regulatory Approval to Integrate Saline Imaging and Advanced AI Features into HyperVue™ Imaging System

Wednesday, September 20, 2023

SpectraWAVE, a prominent player in the field of medical imaging with a primary focus on improving the treatment outcomes for patients dealing with coronary artery disease (CAD), has made a significant announcement regarding the receipt of FDA 510(k) clearance for the expansion of its HyperVue™ Imaging System. This intravascular imaging system seamlessly integrates state-of-the-art DeepOCT™ imaging and near-infrared spectroscopy (NIRS) with an intuitive user interface, revolutionizing the way physicians approach coronary stenting procedures in the cardiac catheterization lab.

The newly cleared product enhancements encompass a range of notable features, including contrast-free saline imaging, artificial intelligence algorithms aimed at assisting in the identification of crucial clinical structures such as calcium and external elastic lamina (EEL), and the introduction of hands-free angiographic co-registration. These innovative additions complement the existing HyperVue toolkit, which already features AI-driven capabilities for lipid, lumen, stent, and sidebranch detection, as well as the Starlight™ Imaging Catheter, designed for a streamlined setup and image acquisition in complex lesion scenarios.

The fusion of DeepOCT and NIRS represents a groundbreaking advancement, delivering vital clinical insights that were previously challenging to obtain. With the inclusion of contrast-free saline imaging and AI-supported image analysis, this product promises to deliver significant value to both seasoned physicians and those new to intravascular imaging.

These recent developments are poised to elevate HyperVue to a new level within the realm of intravascular imaging. Optimal outcomes in stenting procedures, as substantiated by a wealth of clinical studies and analyses, hinge on the ability to obtain high-quality intravascular images and translate that data into actionable clinical decisions. This next-generation intravascular imaging product now serves as the cornerstone of the HyperVue platform, functioning as a diagnostic hub for interventionalists, with the potential addition of Fractional Flow Reserve physiology assessment on the horizon.

Intravascular imaging has evolved into an indispensable tool, enhancing approximately one million coronary stenting procedures conducted annually in the United States. It provides essential insights into plaque morphology, assists in determining plaque modification strategies, aids in sizing stents and balloons, helps select optimal landing zones, confirms treatment efficacy, and assesses the risk of future adverse events.



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