Abbott Receives FDA Clearance for Ultreon 3.0 AI-Powered Coronary Imaging Platform
核心洞察
Abbott (搜索) has received FDA clearance and CE Mark for Ultreon 3.0 (搜索), the first advanced optical coherence tomography system in the U.S. and Europe that integrates high-resolution coronary plaque images with AI-automated insights.
The AI-powered imaging platform provides real-time guidance during percutaneous coronary intervention procedures, helping physicians accurately size and position stents for improved patient outcomes.
The system features one-second OCT pullback technology with higher resolution than intravascular ultrasound and uses minimal contrast, benefiting patients with kidney disease who represent approximately 25% of coronary artery disease patients.
Abbott (搜索) announced it has received U.S. Food and Drug Administration clearance and CE Mark for its next-generation Ultreon 3.0 (搜索) Software, marking the first advanced optical coherence tomography system in the U.S. and Europe to integrate high-resolution coronary plaque images with AI-automated insights. The platform represents a significant advancement in coronary imaging technology designed to support better patient outcomes and reduce procedural risks.
AI-Powered Precision for Complex Coronary Interventions
Ultreon 3.0 (搜索) is an artificial intelligence-powered imaging platform that uses optical coherence tomography to provide doctors with real-time planning guidance during minimally invasive procedures to open blocked heart arteries, known as percutaneous coronary intervention (PCI). The technology enables physicians to visualize the detailed structure of arterial blockages while incorporating AI to assess plaque types, helping doctors choose optimal stent location and sizing to improve blood flow.
"Ultreon 3.0 (搜索) represents a pivotal step forward in how we treat and ultimately care for our patients. This next-generation platform, combining imaging and AI, doesn't just improve upon existing technology — it leapfrogs it," said Evan Shlofmitz, D.O., interventional cardiologist and director of interventional cardiology at St. Francis Hospital and Health Center (搜索) in Roslyn, NY. "By delivering greater clarity, speed, and clinical insight, Ultreon 3.0 accelerates the path to more confident clinician decision making and transformative patient care."
Enhanced Imaging Capabilities and Clinical Benefits
The next-generation software features a one-second OCT pullback, utilizing high-speed infrared light-based imaging to quickly capture detailed cross-sectional views of coronary arteries. This technology offers higher resolution readings than intravascular ultrasound (IVUS) while using low or zero contrast, which may benefit patients with kidney disease who represent approximately 25% of people with coronary artery disease.
The AI and software capabilities of Ultreon 3.0 (搜索) provide several clinical advantages, including clear understanding of blockage size, shape, and location for optimal stent placement, post-procedure assessment to ensure improved arterial blood flow, streamlined setup with enhanced AI-automated insights, and efficient procedure planning specifically tailored for patients with complex coronary disease.
"Abbott (搜索)'s Ultreon 3.0 (搜索) offers a single, AI-driven platform that quickly and easily captures the images physicians need to fully understand the size and angle of the blockage, and create an actionable plan to help the patient," said David M. Leistner, interventional cardiologist at the Clinic for Cardiology and Angiology, Charité Campus Benjamin-Franklin (搜索) in Berlin, Germany. "Every second and every decision matters when treating patients who have blockages in their coronary arteries, and Ultreon 3.0 enables faster, more informed clinical choices that can have a real impact on patients."
Addressing Complex PCI Market Needs
Complex PCI is a specialized procedure used to treat severe coronary artery disease, involving treatment of challenging lesions or plaques that have built up in patients' coronary arteries. Some patients require multiple stents to address these lesions. More than 600,000 people in the U.S. and more than 885,000 in Europe undergo PCI procedures each year.
Built on the success of Ultreon 2.0, the new platform introduces enhanced AI capabilities to provide a simple, fast, and precise solution for complex coronary PCIs. According to Ethan Korngold, M.D., chief medical officer at Abbott (搜索)'s vascular business, "Complemented by our leading coronary portfolio, Ultreon 3.0 (搜索) makes OCT imaging more intuitive and powerful for physicians, reimagining imaging into a tool for precision-guided intervention before and after procedures."
The platform offers a fully integrated workflow designed to support faster, more precise procedures while advancing clinical precision and supporting more consistent care delivery across healthcare systems.