MetaMedical™ Solutions Inc

Philips TEE transducer secures 510(k) clearance from FDA

Philips has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its latest transoesophageal echocardiography (TEE) transducer, designed to help improve cardiac care for more patients.

The Philips X11-4t Mini 3D TEE transducer, which is 35% smaller than its predecessors, is set to transform the diagnosis and treatment of structural heart disease with its high-quality 3D imaging capabilities.

The technology provides cardiologists with detailed heart images, surpassing the capabilities of 2D imaging. This is particularly crucial in life-saving situations and for guiding minimally invasive heart surgeries.

Previously, certain patient groups, including small paediatric patients, adults with potential complications, and complex ICU cases, could not benefit from 3D TEE due to the size of the transducer probe.

The new X11-4t Mini 3D TEE transducer addresses this gap, with its reduced size and pill-shaped design enhancing patient tolerance. A significant 87% of clinical respondents believe the transducer will contribute to improved patient comfort.

It is also designed to integrate seamlessly with existing Philips EPIQ cardiac ultrasound systems, requiring minimal additional training for echocardiographers.

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Philips global cardiology ultrasound vice-president and general manager David Handler said: “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.

“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.”

X11-4t is compatible with Philips’ premium cardiology ultrasound portfolio, including the EPIQ CVx and EchoNavigator image-guided therapy solution, facilitating personalised cardiac care.

The Philips X11-4t ultrasound transducer is expected to be commercially available in 2024 and is currently awaiting CE mark approval in Europe.

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