AVVIGO+ Multi-Modality Guidance System
Boston ScientificThe AVVIGO+ Multi-Modality Guidance System helps physicians perform advanced intravascular and intracardiac ultrasound imaging and physiological assessments during cardiovascular procedures. It offers features like automated stent assessment and side branch display, supporting better clinical decision-making for patients undergoing vascular and cardiac interventions.
Intended Use
The system is intended for ultrasound examinations of intravascular pathology in patients who are candidates for transluminal interventional procedures such as angioplasty and atherectomy, and to compute and display physiological parameters from the cardiovascular system.
Technology
The system combines a display interface, specialized catheters with miniaturized ultrasound probes, physiological assessment hardware (pressure wire and FFR Link), and new software features such as Automated Stent Assessment, Side Branch Display, and IVUSConnect. The system includes updated hardware (Frame Grabber) and maintains the same fundamental technology as the predicate device.
Performance
The system underwent non-clinical performance evaluation, including verification and validation testing for safety and effectiveness according to leading standards (IEC 60601-1, IEC 60601-2-37, IEC 62304, etc.). Automated Stent Assessment algorithm demonstrated a mean absolute error of 13.1% for stent expansion and 0.74 mm² for minimum lumen area. No clinical studies were used; equivalence was supported by non-clinical data.
Predicate Devices
No predicate devices specified
Ready to Sharpen Your Edge?
Subscribe to join 11k+ peers who rely on RadAISlice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.