Indications for Use

The IOPS (Intra-Operative Positioning System) is intended for the evaluation of vascular anatomy as captured using 3D modeling from previously acquired scan data. It is intended for real-time tip positioning and navigation using sensor-equipped, compatible catheters and guidewires used in endovascular interventions in the descending aorta. The system is indicated for use as an adjunct to fluoroscopy. The IOPS does not make a diagnosis.