FDA clears GE HealthCare’s Allia IGS Pulse next generation of image-guided systems

GE HealthCare has gained FDA 510(k) clearance of the Allia IGS Pulse - the latest addition to the company’s image guided system (IGS) offerings - featuring the first monopolar x-ray tube used for interventional procedures providing exceptional image quality and optimized dose management regardless of patient size and including large and bariatric patients with a BMI of greater than 30.

Allia IGS Pulse

Allia IGS Pulse features a new imaging chain engineered to provide exceptional imaging at the right dose for visible impact in complex cardiology interventions regardless of patient size. According to a survey of interventionalists, nearly 50% of interventional procedures are performed at working positions where clinicians have poor access to user interface functions and display. Designed to address these challenges, the new Allia IGS Pulse provides a personalised workspace that meets the operator’s specific needs and preferences.

As part of its new image chain, the system features the first monopolar x-ray tube used to capture images for interventional procedures. This new tube is powerful, yet quieter than normal conversation to optimize the operating environment during a procedure. The small footprint of the new tube also helps clinicians reach steep angulation for better understanding of coronary artery anatomy, even with the 30cm detector configurations. The latest version of MyIQ technology incorporated into the system allows clinicians to select their favourite image look from four different image styles with just one click for a tailored experience at no additional dose.

In the treatment of complex cardiovascular diseases, image quality and optimised dose management regardless of patient size are also important to clinicians. With Allia IGS Pulse, interventionalists are able to get exceptional image quality for large and bariatric patients with a BMI of greater than 30. The system’s reduced pulse width and unmatched X-ray peak power helps to decrease motion blur for better visualization of moving elements such as vessels and devices. To relieve clinicians and technologists of the complex task of optimizing image quality and dose during procedures, Allia IGS Pulse takes AutoRight, the company’s intelligent image chain leveraging AI, a step further with AutoRight PLUS - the next generation of the automation platform.

With AutoRight PLUS, the system now optimises seven parameters in real time, including Focal Spot Shape. By removing the burden of manual adjustment during procedures, clinicians can stay focused on the procedure and treatment of their patients. To further optimize dose along the image chain, a unique suite of tools is also available to help support dose efficiency, dose reduction and dose awareness.