The FDA clearance will allow the use of the Philips’ new X11-4t Mini 3D TEE transducer to serve more patients with enhanced cardiac care including paediatric patients, ICU patients, and older adults
Philips’ X11- 4t Mini 3D TEE transducer gets FDA nod. (Credit: Koninklijke Philips N.V.)
Royal Philips has received the US Food and Drug Administration (FDA) 510(k) clearance for its X11-4t Mini 3D transoesophageal echocardiography (TEE) ultrasound transducer.
The Philips Mini TEE ultrasound transducer is a cardiovascular ultrasound technology designed for early diagnosis of structural heart disease.
The FDA clearance will allow the use of Philips’ new X11-4t Mini 3D TEE transducer to serve more patients with enhanced cardiac care and overall comfort.
It has been authorised to be used on paediatric patients as small as 5kg, adults who are at complications risk, and complex cases like intensive care unit (ICU) patients.
These patients were previously unaddressed as the transducer probe for 3D TEE was considered too large for them, according to Philips.
TEE is said to support cardiologists by offering highly detailed images of the heart and its internal structures.
The quality of a 3D TEE image in structural heart disease can be lifesaving and the 3D visuals are superior to 2D counterparts in terms of clarity and perspective, the Dutch health technology firm said.
Additionally, the device can be used for minimally invasive heart surgeries and procedures like the treatment of damaged heart valves and congenital heart problems.
Philips global cardiology ultrasound VP 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.”
The new X11-4t is said to have a pill-shaped design and a 35% smaller size. It also allows clinical staff to treat a larger patient population with the same hand control, procedure navigation techniques, and workflow that they are accustomed to with Philips EPIQ cardiac ultrasound devices.
The new transducer can be used with Philips’ high-end cardiology ultrasound portfolio, which includes the EPIQ CVx and the EchoNavigator image-guided therapy solution.
Philips’ new X11-4t ultrasound transducer is expected to be commercially available in 2024. It is awaiting CE mark in Europe.