Evident Vascular Guidance System
Evident Vascular, Inc.The Evident Vascular Guidance System is a diagnostic ultrasound system used during cardiovascular procedures to provide real-time images of blood vessels. It helps clinicians visualize vascular pathology and guide treatments such as angioplasty and atherectomy, improving accuracy and patient safety.
Intended Use
The Evident Vascular Guidance System (EVGS) is intended for ultrasound examination of intravascular pathology. Intravascular ultrasound is indicated in patients who are candidates for transluminal interventional procedures such as angioplasty and atherectomy. The Peripheral Imaging Catheters generate ultrasound images and are intended for ultrasound examination of peripheral vascular pathology only.
Technology
The system consists of a workstation, catheter interface module, tablet-based user interface, and single-use intravascular ultrasound catheters; it enables real-time imaging of the peripheral vasculature and can be configured as a mobile cart or integrated into a laboratory. It uses touch-screen controls and optional voice commands. The imaging modality and intended use align with standard IVUS technologies.
Performance
Performance, biocompatibility, electrical safety, electromagnetic compatibility, and acoustic output testing were conducted according to FDA and international standards. Benchtop testing, biocompatibility assessment, software/verification validation, usability (human factors), and cybersecurity testing were all completed and passed. No clinical performance testing was performed.
Predicate Devices
No predicate devices specified
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