Dive Brief:

• Abbott has received 510(k) clearance and a CE mark for a system that uses artificial intelligence to support coronary imaging.
• The device, Ultreon 3.0, combines optical coherence tomography, or OCT, with AI to help doctors assess the plaque blocking blood vessels and inform the selection and placement of stents. Abbott announced the regulatory authorizations last week.
• Ultreon 3.0 builds on the previous version of the device, introducing features to improve clarity, speed and clinical insight.

Dive Insight:

OCT uses infrared light to generate high-resolution images of the vessel wall. Compared to angiography guidance, the technique resulted in a larger minimum stent area in an Abbott-sponsored trial but had no significant effect on target vessel failure at two years. OCT plays an essential role in evaluating the need for lesion preparation and choosing the appropriate stent size, according to clinical guidelines. 

Abbott has incorporated AI into OCT to enhance the technique, receiving a CE mark for Ultreon 1.0 in 2021 and continuing to develop the technology over the following years. The work recently led to 510(k) clearance from the Food and Drug Administration and a CE mark for the third version of the device. 

Ultreon 3.0 “accelerates the path to more confident clinician decision making” by delivering more clarity, speed and clinical insight, Evan Shlofmitz, director of interventional cardiology at St. Francis Hospital and Health Center, said in a statement. As the idea “time is muscle” indicates, how quickly physicians resolve blocked coronary arteries influences health outcomes. 

Abbott’s updated platform uses a high-speed infrared light-based imaging technique to quickly capture cross-sectional views of the coronary artery. The one-second OCT pullback technique delivers higher-resolution readings than intravascular ultrasound with low or zero contrast, Abbott said. Contrast is associated with kidney injury in some patients.   

Other claimed benefits of Ultreon 3.0 include post-procedure assessments to ensure the stent improved blood flow in the artery, plus enhanced AI-automated insights intended to simplify the physician’s workflow.

The device joins a portfolio of vascular technologies that generated 9.5% sales growth on a comparable basis in the first quarter.