Philips
(NYSE: PHG)
announced today that the FDA granted 510(k) clearance to its latest TEE transducer technology.
The Dutch medtech giant designed its transesophageal echocardiography (TEE) ultrasound transducer to help in the early diagnosis of structural heart disease. TEE helps cardiologists by providing highly detailed images of the heart and its internal structures.
Additionally, TEE can help in minimally invasive heart surgeries and procedures. That includes the treatment of damaged heart valves and congenital heart defects.
Philips said the latest TEE system, its X11-4t Mini 3D transducer, opens up the treatment option to a much wider population. Previously, pediatric patients, adults at risk of complications and other complex cases couldn’t access the treatment because 3D TEE proved too large. The new Mini transducer allows previously unaddressed patients to access TEE.
According to Philips, the new transducer registers at 35% smaller than previous versions with a pill-shaped design. It aims to enhance the patient experience, including patient comfort.
“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 GM 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 anesthesia and lower the risk of complications, meaning patients may recover faster from procedures and can be discharged sooner.”