Royal Philips has received US Food and Drug Administration (FDA) 510(k) clearance for its X11-4t transoesophageal echocardiography (TEE) ultrasound transducer, a move that the company says will open up 3D TEE imaging to previously unaddressed patients.
TEE provides detailed images of the heart and its internal structures, though currently there are some patients including paediatric patients as small as 5 kg, adults at risk of complications, as well as complex cases such as ICU patients, where the transducer probe for 3D TEE was too large for use.
“In many of our smallest patients undergoing complex intracardiac procedures like valve repairs, 3D TEE will give us a new and much needed perioperative tool. For example, the X11-4t can help us visualise atrioventricular valves en-face. In many cases, this is a view that is difficult to achieve with traditional 2D TEE. 3D TEE will also be a more effective tool to communicate with the surgeons and will enable us to give good “surgeon views” of intracardiac structures,” said Brian Soriano (University of Washington, Washington, USA).
“As a pioneer and leading innovator in cardiac ultrasound, our 3D ultrasound technology plays a critical role in many cardiac procedures. But it was frustrating to know that there were still some patients who couldn’t benefit from this hugely beneficial approach to image the heart, and as a result, would often require a different, more invasive, treatment approach,” said David Handler, VP and general manager for Global Cardiology Ultrasound at Philips. “That’s why we’ve developed a new, even smaller mini 3D TEE transducer that can be used to help physicians serve a wider range of patients, from small children to fragile adults. With this innovation we can help reduce the need for general anaesthesia and lower the risk of complications, meaning patients may recover faster from procedures and can be discharged sooner.”
“With its excellent image quality and small footprint, the X11-4t transducer has the potential to reduce the complications of prolonged transoesophageal imaging which can occur during our most difficult structural heart procedures. The transducer’s small size may also be better tolerated by patients during shorter procedures performed under conscious sedation and thus, provide additional high-quality imaging to improve procedural outcomes without the need for general anesthesia,” said Rebecca Hahn (Columbia University Irving Medical Center, New York, USA).
