FDA clears next-generation image system to guide cardiac interventions
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Key takeaways:
- The FDA granted 510(k) clearance to a new image-guided system for use during interventional CV procedures.
- The system is designed to provide optimized imaging regardless of patient size.
GE HealthCare announced it received FDA 510(k) clearance of its next-generation image-guided system, designed to optimize imaging at the right dose regardless of patient size, for use during interventional CV procedures.
The new system (Allia IGS Pulse) is designed to provide a workspace to meet the operator’s specific needs and features a monopolar X-ray tube used to capture images for interventional procedures, according to a company press release.
Image: Adobe Stock
Noise from the new X-ray tube does not exceed that of normal conversation and its small footprint is engineered to allow steep angulation for improved viewability of coronary artery anatomy, according to the release.
The system also features the company’s next-generation artificial intelligence-based automation platform (AutoRight PLUS), designed to optimize seven parameters in real time, including Focal Spot Shape, and remove the need for manual adjustment during procedures, according to the release.
“As an operator of the Allia IGS Pulse system, I felt a significant and real improvement in the imaging quality, as well as a significant reduction of this noise in my daily procedures which gave me great confidence and comfort in the operating room,” Nicolas Dumonteil, MD, interventional cardiologist at Clinique Pasteur, Toulouse, France, said in the release. “The system is also quite adaptable and versatile to all of my daily situations and procedures — from percutaneous coronary interventions (PCIs) to other complex and structural ones.”
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