ViTAA Medical’s aortic surgery planning tool has gained clearance from the US Food and Drug Administration (FDA), representing the first milestone in the company’s aim to bring a full spectrum aortic care platform to market.
ViTAA’s AiORTA Plan is an AI-based tool that is designed to assist physicians in their preparations for complex aortic procedures.
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Using AI to automatically generate key preoperative measurements for aortic surgical cases, such as aneurysm segmentation, centreline generation, and volumetric analysis protocols, the cloud-based tool aims to improve precision and reproducibility in aortic surgical interventions and reduce manual planning work.
Based in Canada, ViTAA said that AiORTA Plan will be joined by AiORTA Maps and AiORTA Watch in future to create a full-suite AiORTA vascular care platform.
AiORTA Maps applies AI to CT scans to provide surgeons with vessel-integrity insights such as thrombus burden, relating to the size and distribution of intraluminal thrombus (ILT), and outcome predictions.
When data collection with the tool is complete, it creates a region-by-region index called the regional aortic weakness (RAW) Score. Validated by ViTAA on the basis of 15 years of research and more than 200 aortic tissue samples, it aims to help clinicians identify vulnerable areas of the aorta with greater precision.
ViTAA added that once Maps is on the market, critical wall weakness indications will be integrated into Plan.
Maps is currently involved in a prospective registry study (NCT05004051) wherein it is being used to collect imaging and clinical data on patients with aortic aneurysm disease undergoing monitoring, and on pre and post-endovascular repair patients, according to an entry on Clinicaltrials.gov. According to Vitaa’s website, research using Maps is also currently being undertaken at 40 US sites.
The final component of Vitaa’s AiORTA platform is Watch, a tool that is being developed to provide real-time monitoring of aortic health.
AiORTA Plan’s FDA clearance validates the company’s approach of combining automation with precision medicine, according to its CMO Dr Randy Moore.
Moore said: “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studies for AiORTA Maps and AiORTA Watch, we’re focused on delivering solutions that help physicians see beyond outdated size guidelines and gain insights into vessel behaviour that can inform decision-making throughout the patient journey.”
