New Philips Mini TEE ultrasound transducer helps improve cardiac care for more patients
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The FDA 510(k) clearance of Philips' X11-4t Mini 3D TEE transducer represents a significant advancement in the field of cardiac imaging. The ability to provide high-quality 3D images for a broader patient demographic, including pediatric and high-risk adult patients, could potentially lead to better procedural outcomes and reduced reliance on general anesthesia. This innovation aligns with current trends towards minimally invasive procedures, which aim to decrease patient recovery time and hospital stays.
The introduction of this technology could have a positive impact on Philips' market position within the cardiac ultrasound sector. By expanding the usability of their TEE transducer to previously inaccessible patient groups, Philips may capture a larger market share, potentially increasing their revenue streams. As minimally invasive procedures continue to gain traction, the demand for advanced imaging technologies like the X11-4t is expected to rise, offering Philips a competitive edge.
From an economic perspective, the adoption of Philips' X11-4t Mini 3D TEE transducer could lead to cost savings within the healthcare system. By reducing the need for general anesthesia and associated risks, there may be a decrease in perioperative costs and postoperative care expenses. Furthermore, the potential for faster patient recovery and shorter hospital stays could result in reduced healthcare resource utilization, contributing to overall efficiency gains.
These economic implications might also influence insurance providers and healthcare facilities when considering the cost-benefit analysis of incorporating such technology into their standard care protocols. The long-term impact on healthcare costs will depend on the rate of adoption and the extent to which this technology can replace more invasive procedures.
Market trends indicate a growing emphasis on patient comfort and procedure efficiency, which the X11-4t Mini 3D TEE transducer directly addresses with its reduced size and compatibility with existing Philips ultrasound systems. This suggests that the product could be well-received by clinicians seeking to enhance their practice with state-of-the-art technology that doesn't require extensive retraining.
Analyzing the competitive landscape, Philips' innovation may prompt responses from other industry players, potentially accelerating the development of similar technologies. It will be important to monitor how this product's introduction affects Philips' stock value and market dynamics, especially regarding partnerships, product adoption rates and potential entry into new markets pending CE mark approval in Europe.
January 31, 2023
- Latest innovation has the potential to reduce anesthesia during minimally invasive procedures [1]
- As a pioneer and leading innovator in cardiac ultrasound, Philips has developed the smaller X11- 4t Mini 3D TEE transducer to serve more patients with this valuable imaging tool, from pediatric patients to older adults and everyone in between
Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced that its latest TEE transducer, designed to serve more patients with improved overall comfort, has received FDA 510(k) clearance.
Cardiovascular ultrasound has played a key role in the evolution of early diagnosis of structural heart disease, led by a technology pioneered by Philips: the ‘transesophageal echocardiography’ (TEE) ultrasound transducer. TEE helps cardiologists by providing highly detailed images of the heart and its internal structures. In structural heart disease, the quality of a 3D TEE image can help save lives. The clarity and perspective that come with 3D images exceed 2D alternatives. TEE is also a valuable tool for minimally invasive heart surgeries and procedures, transforming the treatment of damaged heart valves and congenital heart defects [2].
However, there were some patients who still couldn’t benefit from this advanced technology, including pediatric patients as small as 5 kg, adults at risk of complications [3], as well as complex cases such as ICU patients [4], where the transducer probe for 3D TEE was too large. Until now. Announced today, Philips’ new X11-4t Mini 3D TEE transducer is shifting that balance and opening 3D TEE imaging to previously unaddressed patients [5].
“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” said Dr. Brian Soriano, Pediatric Cardiologist (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 anesthesia [6] and lower the risk of complications, meaning patients may recover faster from procedures and can be discharged sooner.”
Early clinical users who’ve had the opportunity to carry out procedures with the new transducer have recognized its value. “With its excellent image quality and small footprint, the X11-4t transducer has the potential to reduce the complications of prolonged transesophageal 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 Dr. Rebecca Hahn, Professor of Medicine at Columbia University Irving Medical Center (New York, USA) and Director of Interventional Echocardiography at the Columbia Structural Heart & Valve Center (New York, USA).
Improved patient comfort, with seamless workflow integration for clinicians
Developed to be easily tolerated by patients due to its
The new transducer is compatible with Philips’ premium cardiology ultrasound portfolio including the EPIQ CVx and EchoNavigator image-guided therapy solution, allowing clinicians to deliver personalized, efficient, and clinically smart cardiac care to help improve outcomes and the patient experience. It also joins a portfolio that includes another significant innovation – VeriSight Pro – the first 3D intracardiac echocardiography catheter to miniaturize the same 3D imaging technology that powers TEE.
Transforming echocardiography with AI
More than 100 cardiac measurements are routinely performed as part of every echocardiography exam, taking up
The Philips X11-4t ultrasound transducer is scheduled for commercial availability in 2024 and is pending CE mark in Europe.
[1]
[2] Transesophageal Echocardiography | American Heart Association
[3] Schmidt S, Dieks JK, Quintel M, Moerer O. Critical Care Echocardiography as a Routine Procedure for the Detection and Early Treatment of Cardiac Pathologies. Diagnostics (Basel). 2020;10(9):671. Published 2020 Sep 4. [4] Freitas-Ferraz AB, Bernier M, Vaillancourt R, et al. Safety of Transesophageal Echocardiography to Guide Structural Cardiac Interventions. J Am Coll Cardiol. 2020;75(25):3164-3173.
[5] When compared to the X8-2t including comparison with tip width of X8-2t.
[5] Signify Ultrasound Transducers & Catheters World Market Report – 2021 Edition.
[7] Assessment based on feedback from a demo study, of 30 clinical respondents, when comparing to the X8-2t
[8] Guidelines for performing a comprehensive transthoracic echocardiographic examination (TEE) in adults. Recommendations from the American Society of Echocardiography, 2019.
For further information, please contact:
Kathy O’Reilly
Philips Global External Relations
Tel.: +1 978-221-8919
E-Mail: kathy.oreilly@philips.com
About Royal Philips
Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving people's health and well-being through meaningful innovation. Philips’ patient- and people-centric innovation leverages advanced technology and deep clinical and consumer insights to deliver personal health solutions for consumers and professional health solutions for healthcare providers and their patients in the hospital and the home. Headquartered in the Netherlands, the company is a leader in diagnostic imaging, ultrasound, image-guided therapy, monitoring and enterprise informatics, as well as in personal health. Philips generated 2023 sales of EUR 18.2 billion and employs approximately 69,700 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter.
Attachments
- Clinician using Mini TEE 3D Transducer on pediatric patient
- 3D View of young pediatric patient heart view
- 3D view of adult left atrial appendage
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