Vascular Navigation PAD 2.0; Navigation Software Vascular PAD

Vascular Navigation PAD 2.0 is software that provides image guidance during endovascular procedures for peripheral artery disease (PAD) in the lower limbs by overlaying vessel anatomy onto live fluoroscopic images. It helps physicians navigate guidewires, catheters, stents, and other endovascular devices during minimally invasive vascular interventions, intended for use in adults in the operating room.

The device performs 2D-2D image registration (synchronization), modality detection to differentiate fluoroscopic from angiographic images, image stitching with manual adjustment, marking functionality, and roadmapping (overlay alignment) with semi-automated registration. It does not use artificial intelligence or machine learning and lacks 3D-2D fusion, measurement functions, or automatic motion detection available in the predicate device.

Not stated in this summary. The document references Brainlab internal processes for product design and development but does not cite specific ISO, IEC, ASTM, or other consensus standards.

Both the subject device and predicate (EndoNaut) provide 2D-2D image registration to overlay previously captured vessel anatomy onto live fluoroscopic images for positioning endovascular devices in lower-limb procedures. The subject device achieves the same clinical function with similar performance characteristics: roadmapping accuracy of 1.57 ± 0.85 mm versus the predicate's acceptable error. Differences—such as the subject device lacking 3D-2D fusion and automatic motion detection—are not material because these features are not required for the claimed PAD indication and do not introduce additional safety risks. Both devices use identical operating systems, similar hardware platforms, comparable stitching and registration algorithms, and share identical input/output data types.