OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System
Abbott MedicalThe OPTIS Mobile Next Imaging System and OPTIS Integrated Next Imaging System by Abbott Medical are advanced OCT imaging systems designed for use in cardiovascular catheterization labs. Paired with compatible Dragonfly imaging catheters, these devices provide detailed imaging of coronary arteries and physiological measurements to help physicians assess coronary lesions and determine the need for intervention.
Intended Use
The OPTIS Next Imaging System with compatible Dragonfly imaging catheters is intended for imaging coronary arteries in patients who are candidates for transluminal interventional procedures in vessels 2.0 to 3.5 mm in diameter, and for computing and displaying physiological parameters to aid clinical decision making.
Technology
The system includes a cart-mounted or integrated PC, imaging engine, and power supply, paired with Dragonfly OCT imaging catheters. It performs OCT imaging and measures physiological parameters including resting full-cycle ratio (RFR) and fractional flow reserve (FFR). Software enhancements include automated morphology assessment (calcium and External Elastic Lamina), live angiography display, and improved user workflows. Hardware updates include GPU, CPU, memory, and cybersecurity improvements.
Performance
Verification and validation testing, including software verification, human factors usability study, hardware and packaging testing, were completed to demonstrate safety and effectiveness. No new clinical testing was done, but clinical literature analysis supported labeling changes related to resting full-cycle ratio (RFR). The device modifications did not raise new safety or effectiveness questions compared to the predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
2/16/2021
3 months - 2
FDA Approval
6/8/2021
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.