Brainlab company is pleased to announce that their Vascular Navigation PAD software used for mobile C-arms has received FDA 510(k) clearance for the US market

03/02/2026

Brainlab company is pleased to announce that their Vascular Navigation PAD software used for mobile C-arms has received FDA 510(k) clearance for the US market. This advancement allows for the treatment of peripheral artery disease (PAD) with reduction in radiation and contrast agent, enhancing safety for physicians and patients.

Vascular Navigation PAD software enables:

• Reduce radiation, protect your staff. The reduction of radiation per procedure is especially important for physicians and staff, who perform multiple procedures every day and have an increased risk of health issues due to radiation exposure. It also lowers radiation-induced complication risks for your PAD patients.

• Minimize contrast agent,lower patient risks. Patients with PAD often have comorbidities that impair kidney function, making them more vulnerable to the harmful effects of nephrotoxic contrast agents. Reducing the number of DSA images required for device navigation means you can minimize contrast agent volume, reducing the risk to kidney health.

• Reuse your roadmap, simplify navigation․ Marking the stenosis or areas of interest on a single, reusable roadmap allows you to access the complete anatomy at a glance. Re-approach locations at any time without repeated DSAs.

With Vascular Navigation PAD, physicians can create roadmaps of the entire vessel tree of the lower extremities and iliac arteries. By leveraging advanced image fusion, they can reuse the same roadmap throughout the endovascular revascularization procedure, potentially eliminating the need for repeated digital subtraction angiography images (DSAs) even when the C-arm or patient is moved—resolving a key inefficiency of mobile C-arms.

Additionally, our Digital O.R. features are now available in a mobile setup. The Elements Viewer enables access to Pre-OP CT-A anytime during the procedure from anywhere in the O.R., improving precision and efficiency․