ViTAA Medical today announced that the Food and Drug Administration (FDA) has granted 510(k) clearance for AiORTA Plan, which the company describes as a “fully automated, hyper-precise aortic surgery planning solution”.
The tool aims to automate key preoperative measurements and streamline aortic case preparation by generating a complete aortic plan in minutes in a web-based system, producing automated aneurysm segmentation, centerline extraction, precise diameter and angulation measurements, and instant volumetric modeling.
The other elements of ViTAA’s broader AiORTA platform—which also includes AiORTA Maps and AiORTA Watch—are currently in multicenter clinical studies. Maps is a diagnostic aid that aims to produce patient-specific vessel strength analysis, while Watch looks to provide longitudinal monitoring for early complication detection.
“Regulatory clearance of AiORTA Plan validates our approach of combining automation with precision medicine,” said Randy Moore (Calgary, Canada), a vascular surgeon and chief medical officer at ViTAA Medical. “As we continue our international clinical studies for AiORTA Maps and AiORTA Watch, we’re focused on delivering solutions that help physicians see beyond outdated size guidelines and gain insights into vessel behavior that can inform decision-making throughout the patient journey.”
“This FDA clearance is a foundational milestone for ViTAA,” said Mitchel Benovoy, ViTAA Medical CEO. “AiORTA Plan brings hyper-precision, efficiency, and extreme speed to the front line of the aortic workflow. It’s the first step in our platform strategy: from pre-operative planning with AiORTA Plan to critical vessel-integrity insights and outcome predictions with AiORTA Maps, and long-term postoperative endoleak surveillance and risk stratification with AiORTA Watch—both currently in clinical studies. Our vision is end-to-end, patient-specific vascular care at every stage of the disease.”
Frank J. Veith (New York, USA), who performed the first endovascular aneurysm repair (EVAR) of an abdominal aortic aneurysm (AAA) in the U.S. three decades ago, hailed the approval as a milestone. “This is an important advance,” he said. “AiORTA Plan can streamline how physicians prepare for complex aortic procedures, and as the broader AiORTA platform matures with Maps and Watch in clinical evaluation, it has the potential to transform individualized care by providing critical insight.”
