Intra-Operative Positioning System (IOPS®)
Centerline Biomedical, Inc.The Intra-Operative Positioning System (IOPS®) is a surgical navigation tool that helps clinicians navigate catheters and guidewires during endovascular procedures. It uses pre-acquired 3D vascular imaging data combined with real-time electromagnetic tracking to display precise tip positioning, serving as an adjunct to fluoroscopy. This technology enhances procedural accuracy without making direct diagnoses.
Intended Use
The IOPS is intended for evaluation of vascular anatomy via 3D modeling from previously acquired scan data, and for real-time tip positioning and navigation using sensor-equipped catheters and guidewires during endovascular interventions in peripheral, aortic and aortic side branch vasculature. It is used as an adjunct to fluoroscopy and does not make a diagnosis.
Technology
The IOPS consists of a surgical navigation system employing electromagnetic tracking technology that displays the position and orientation of sensor-equipped catheters and guidewires in real time. It maps the patient's vascular system using previously acquired CT scan data, registering sensor location to the vascular map to guide navigation, displayed on a monitor. Associated accessories include guidewires, catheters, fiducial tracking pads, and guidewire handles.
Performance
The device was supported by software verification and design validation testing, including usability studies for cannulation targeting in peripheral, aortic and aortic side branch vasculature. No new hardware changes were made, so no additional electrical, mechanical or thermal safety testing was required. No clinical or animal testing was conducted. The performance testing confirmed safety and equivalence to predicate devices.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/13/2024
2 months - 2
FDA Approval
3/6/2025
Other devices from Centerline Biomedical, Inc.
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