Miniaturized transesophageal echocardiography transducer gains FDA 510(k) clearance
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Key takeaways:
- A next-generation miniaturized transesophageal echocardiography transducer has received FDA 510(k).
- The device is designed to expand the patient population eligible for transesophageal echocardiography.
Philips announced it received FDA 510(k) clearance of its next-generation, miniaturized, transesophageal echocardiography transducer which can be used in very small patients and complex ICU cases.
With its 35% smaller size and pill shape, the device (X11-4t Mini 3D TEE transducer) is designed to improve patient comfort, according to a company press release.
The device requires minimal additional training, as it is designed with the same hand control, procedure navigation techniques and workflow as the company’s prior cardiac ultrasound systems (EPIQ CVx and EchoNavigator), according to the release.
“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 visualize 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,” Brian Soriano, MD, pediatric cardiologist at Seattle Children’s, said in the release.
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