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SpectraWAVE secures 510(k) clearance of HyperVue intravascular imaging system

Press releases may be edited for formatting or style | March 01, 2023 CT X-Ray

Initial cases from the first-in-human study (NCT05241665) have been conducted at the Department of Research Innovation, Angiografia de Occidente in Colombia, South America under the guidance of site Principal Investigators Antonio Dager, M.D., Interventional Cardiologist and Director of the Structural Heart Program, as well as study Principal Investigator Dr. Ali.


About SpectraWAVE, Inc.
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SpectraWAVE, located in Bedford, Mass., is a privately held medical device company founded in 2017 to provide unrivaled optical and computational insights to improve the treatment and outcomes for patients with coronary artery disease (CAD). CAD, the buildup of plaque in the wall of the arteries that supply blood to the heart, affects 18.2 million adults age 20 and older. In CAD patients that undergo percutaneous stent placement, it is estimated that one in five patients experience adverse events within two years. SpectraWAVE’s state of the art HyperVue™ Imaging System combines next generation DeepOCT™ images and near infrared spectroscopy (NIRS) with workflows optimized for the cardiac catheterization 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.

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