| Developers: | Philips Healthcare |
| Date of the premiere of the system: | February 2017 |
| Last Release Date: | September 2020 |
| Branches: | Pharmaceuticals, Medicine, Healthcare |
Content |
2024: System announcement for vascular surgeons with 3D imaging
On February 27, 2024, Philips announced the next generation Azurion system for minimally invasive angiographic studies and interventions. This is a multifunctional table for vascular surgeons with 3D imaging.
Philips says minimally invasive procedures performed with intervention systems such as Azurion are a key part of stroke diagnosis and treatment, where every minute is important to preserve a patient's quality of life. In addition, such medical complexes are used to precisely plan and perform complex neurovascular procedures, such as therapy for brain aneurysms and birth defects.
The new Azurion system features improved 2D- and 3D imaging and flexibility in positioning the X-ray detector. This improves the effectiveness of surgical procedures, improves the quality of care for patients and reduces the overall cost of treatment. Thanks to improved controls, doctors do not need to leave the sterile field. Automatic rotation of the beam is implemented to obtain correctly oriented images at any angle of inclination and rotation.
In addition to expanding functionality, Philips maximized the uptime of angiography equipment by introducing artificial intelligence and machine learning tools. Such tools are used to monitor the state of the system and identify potential problems that may lead to breakdown or downtime. In particular, AI algorithms predict probable component failures in at least 7 days, which allows you to take the necessary measures in advance to maintain equipment or replace unreliable elements at a convenient time and without interrupting the workflow.[1]
2023
A defect in which the angiograph irradiates the patient
On August 21, 2023, Philips announced the detection of a defect in its systems for performing angiographic procedures. Complexes designed to contrast blood vessels can reportedly irradiate patients.
The defect affects the Philips Allura Xper, Allura Centron, Azurion and MultiDiagonal-Eleva systems, which are also supplied to the European market. The official notice says the issue is related to foot switches that control fluoroscopy, exposure and other functions. These are, in particular, lighting control, switching between X-ray planes, creating single images, etc.
Due to the defect, the switch pedal can remain in the active position even after the medical officer removes her leg. This results in excessive radiation to which the patient is exposed. Philips highlights several causes that can lead to a defect. In particular, the problem arises from the accumulation of dense or sticky deposits on the switch that impede its normal operation. As a preventive measure, it is recommended to carry out regular cleaning in this case.
In addition, incorrect operation of foot switches can be observed when using protective covers of inappropriate size or their incorrect placement. Another reason is the displacement of the mounting screw in the switch design. Plus, in some cases, at the production stage, an additional screw could accidentally get into the switch body, which can also interfere with the normal functioning of the angiograph pedals. There is no information on cases of harm to the health of patients due to the use of defective equipment as of mid-August 2023.[2]
Philips warned of suddenly breaking angiographs
In mid-June 2023, Philips issued an urgent safety notice for its Allura and Azurion image-pointing therapy systems, which can be customized with a FlexMove carriage.
The FlexMove device allows you to park the rack in the waiting position and then move it to the desired position during the procedure. FlexMove allows you to move the rack longitudinally and transversely along guides that are mounted on the ceiling.
The notification warns of a problem that may occur due to forces applied during C-arc movement for Allura and Azurion devices. As a result, Philips' image-pointing therapy systems may cause FlexMove carriage to weaken or break, and cracks may appear in it.
In the event that the FlexMove rail attachment bolts loosen or break, cracks appear and a number of problems may arise. These include stopping C-Arc transverse movements due to false collision detection or due to additional friction. The problem can also cause manual movement to be disabled due to additional friction. In the following cases, uncharacteristic noise, unstable suspension and falling C-Arc may also occur.
Loss of C-Arc mechanical movements during the procedure may result in delay or interruption of the procedure. While the likelihood of serious injury or death for patients remains unlikely, Philips said it cannot be ruled out. Breaking or falling a C-Arc can lead to injuries of varying severity. This issue affects all Azurion and Allura Xper systems installed with the FlexMove option.
Philips as of June 2023 received 14 complaints related to 11 systems that reported loose or broken bolts. In three cases, users found cracks. None of these cases involved a breakdown or fall of the C-Arc assembly and the company received no reports of harm to patients or strangers.
Philips engineers plan to inspect all affected systems, check the presence of cracks and the reliability of bolts. The company intends to replace all weakened and broken bolts. In the event that it is not possible to replace loose or broken bolts during the inspection, or if cracks are found during the inspection, Philips intends to plan to replace the damaged bolts or the entire carriage.
According to Massdevice, after these actions from Philips, the systems can be safely continued to be used for at least one year. Philips said its technicians continue to work on a permanent solution to the problem.[3]
2021: Integration with Spectrum 7500 CT
In November 2021, Philips introduced the world's first device that combines CT imaging and angiography. To do this, the Dutch manufacturer integrated a Spectral 7500 computed tomograph with an Azurion angiograph with FlexArm.
As reported in the press release, the idea of this project is to combine two key methods of medical imaging and provide access to them in one operating room - it is not necessary to move the patient from one office to another. If necessary, each system can work autonomously, and the second will be moved to the "parking space." CT scans require one scan to more accurately plan minimally invasive procedures.
Continuous spectral CT technology provides improved detection, delineation and quantification of lesions, allowing better planning of minimally invasive procedures and more accurate surgical interventions, the developers said. In oncology, spectral CT also demonstrated higher sensitivity in the detection of malignancies.
 | We are very happy to bring these technologies together and integrate, as this will help us look at the treatment of a number of diseases through the prism of completely new innovative ways, potentially offering new treatment opportunities and improving patient care, "said Barry Katzen, founder and chief medical officer of the Miami Institute of Cardiovascular Diseases at Baptist's Health Hospital. |  |
This institute, as well as the Mayo Clinic, were among the first to be able to simultaneously use the Spectral 7500 scanner with an Azurion angiograph with FlexArm in one operating room.
Philips explained that the total cost of a comprehensive angioCT solution will not consist of the prices of two devices, since such a system is equipped with special technologies and programs. At the same time, the manufacturer did not disclose the market price of such a product.[4]
2020
Azurion Lung Edition Announcement
In late September 2020, Philips Healthcare released the Azurion Lung Edition imaging system designed to diagnose and treat lung cancer. The novelty is a 3D imaging and navigation platform that should speed up and facilitate interventions in lung cancer by combining CT-like 3D images obtained by examination with real-time X-ray inspection and other tools to support procedures on the lungs under visual control.
The Azurion Lung Edition system uses cone beam computed tomography equipment and is designed specifically for bronchoscopy procedures, allowing clinicians to perform minimally invasive endobronchial biopsy and ablation of lesions during the same procedure, the developers said.
Early diagnosis and rapid treatment are critical to ensuring the best outcomes and quality of life in lung cancer patients, with each week of delay resulting in a 5% increase in mortality. Cone-beam CT is considered the gold standard for both diagnosis and treatment of lung cancer in the same room and even during the same procedure. By speeding up diagnosis and treatment, Azurion Lung Edition helps transform lung cancer treatment, significantly improves intervention outcomes and reduces costs.
| | Minimally invasive procedures with visual control are becoming available in new areas of medicine thanks to such Azurion Lung Edition systems, - said the chief physician of Philips for visual therapy, Dr. Atul Gupta. - As lung cancer is increasingly detected in the early stages, new minimally invasive treatment strategies, such as ablation, can significantly improve therapy outcomes.[5] | |
Next generation Azurion platform announcement
In early September 2020, Philips Healthcare introduced a new generation of its Azurion platform to perform minimally invasive angiographic research and interventions. According to the manufacturer, the new version of Azurion combines applications for imaging, evaluation of physiological characteristics and hemodynamic indicators.
According to Philips, the platform allows you to control the position of gentry directly from the doctor's workplace, as well as monitor all compatible applications from the touch screen during procedures. Azurion's intuitive interface optimizes workflow and enables a wide range of minimally invasive procedures. The firmware platform also allows new functionality and Philips applications to be added to the system as they are developed.
Among other things, Philips has included a SmartCT 3D imaging app in the platform. This tool recreates 3D images similar to CT results and can be used in neurological, oncological and cardiovascular procedures. The new version of Azurion also includes the IntraSight tool, the Instant Free Wave Index (iFR) measurement function, the Fractional Flow Reserve (FFR) estimation function, the Intravascular Ultrasound Instrument (IVUS), and for joint recording of various indicators.
Azurion's other new features include fully automated patient position control, cybersecurity tools, high-definition imaging capabilities, and remote maintenance and preventive inspection services. The platform is now available in three versions: Azurion 3, Azurion 5 and Azurion 7.[6]
2019
Integration with Microsoft HoloLens 2 for augmented reality
In late February 2019, Philips Healthcare introduced augmented reality apps developed in collaboration with Microsoft for minimally invasive therapies. The applications are designed for the Philips Azurion medical vascular research platform and work using the Microsoft HoloLens 2 mixed reality helmet. This technology will allow owners of the HoloLens 2 headset to access a virtual screen displaying data from the Azurion system in real time.
Microsoft unveiled the new concept alongside the HoloLens 2 augmented reality headset at MWC 2019 in Barcelona. HoloLens is an autonomous holographic computer that allows doctors to interact with 3D digital objects.
The Philips and Microsoft augmented reality concept created for HoloLens 2 turns images that typically appear on large 2D screens into a three-dimensional holographic projection. The platform allows you to integrate data from several sources in such a way that it can be easily understood and interpreted. In addition, the new system gives the doctor the ability to monitor the operation of the Azurion platform using voice recognition, tracking eye movements and gestures.
The augmented reality concept for medicine, as demonstrated by Philips and Microsoft, is used to collect additional clinical data to develop future commercial augmented reality technologies for use in medical imaging procedures.
The partners also note that the shift from open surgery to minimally invasive, visually supervised procedures has led to improved treatment outcomes and reduced costs, not least by dramatically reducing the length of a patient's hospital stay after the procedure. Philips and Microsoft are confident that the potential for using augmented reality in healthcare and, in particular, in minimally invasive surgery is unusually wide.[7]
Azurion 7 C20 announcement with FlexArm support
In late January 2019, Philips Healthcare unveiled an updated version of its Azurion visual-controlled angiography platform.
The Azurion 7 C20 system with FlexArm is equipped with tools that allow doctors to visualize the entire patient in both 2D and 3D. The system moves along eight different axes thanks to the Philips Axsys controller. This makes it possible to reduce the movement of the patient during procedures. When a doctor moves the system, it automatically assesses its movement relative to the patient, providing more consistent imaging and allowing the specialist to focus on treatment.
FlexArm positioning flexibility allows the medical team to sit around the patient in the most convenient way so as not to interfere with each other and perform the operation more efficiently. The C-arm range of movements (270 degrees) allows for any necessary angle without forcing doctors to move the patient's desk.
Simulation trials conducted by clinicians demonstrated the system's ability to significantly reduce patient displacement during the procedure as well as reduce the need for staff and equipment movements. All of this improves access in minimally invasive procedures, including radial access through the patient's wrist, reduces the risk of unintended dropping of probes and catheters, and significantly reduces the duration of the procedure. In general, the use of the new system allows a 27% reduction in the preliminary stage of patient positioning.
According to the company, the system is ideal for hybrid operating rooms, in which doctors perform both surgical and endovascular procedures. The system allows different medical teams of specialists to work in the same operating room.[8]
2018: Presentation in Russia
On May 18, 2018, Philips introduced the Azurion angiographic system in Russia. Philips technologies implemented in the Azurion system will allow doctors to provide care to more patients and perform more complex procedures, doing so consistently and with fewer errors, the company said.
| | "The launch of the innovative angiographic system Azurion on the Russian market will help in solving the urgent problems of domestic health care in the field of interventional radiology," comments Andrei Marulin, head of the Intervention X-Ray department at Philips. "I am sure that this system will increase the convenience in the work of Russian specialists, will be easy to manage, and most importantly, it will allow you to receive high quality images with a reduced beam load." | |
Philips Azurion uses many new components developed in conjunction with clinical specialists and contributing to higher reliability and speed of diagnostic tasks. Thanks to the TSM Pro sensor control module, physicians have the ability to select, zoom in and pan X-ray images without moving away from the operating table, as well as view series of images and control collimation. The FlexVision Pro widescreen monitor, implemented in the Azurion system, helps to fully control all programs in the X-ray operation without leaving the sterile zone during the procedure.
The Azurion angiographic system allows you to significantly save time by simultaneously performing two tasks at once - in the remote control and operating room. For example, while a fluoroscopy or X-ray is being performed, the X-ray radiator in the remote can quickly view previously obtained images of the same patient, prepare the next study, or fill in the protocol of the previous patient. Quantitative analysis of images can also be carried out in the remote control without interrupting work in the operating room.
Thanks to the new MRC200 + X-ray tube, doctors can conduct longer studies, as well as obtain high-quality images in deep projections even in patients of large build. Moreover, the X-ray tube is equipped with a SpectraBeam filtration system, which helps to maintain high image quality at low radiation doses. The Azurion system enables doctors to see how their actions will affect the image and prepare for the next step without applying fluoroscopy. Zero Dose Positioning allows you to move, adjust the height and adjust the field of view based on the last image received.
2017: Announcement of a solution based on Volcano technologies
In February 2017, the Dutch company Philips Healthcare announced an X-ray installation for cardiovascular diagnostics Azurion. The manufacturer calls the release of this product its most significant event in recent years.
The Azurion angiographic system, used for interventional radiology, allows doctors to see the smallest changes in the vascular bed thanks to high-quality and accurate imaging.
The product was created using the technologies of the American company Volcano, one of the leaders in the field of intravascular research and interventional vascular surgery. Philips closed its $1.2 billion acquisition in the first quarter of 2014.
Azurion uses modified equipment from similar Philips Allura and Allura Clarity systems. In addition, the C-type frame, flat-panel digital detectors and the Philips MRC X-ray tube have been modernized. The manufacturer has optimized installation control by "sewing" some controls into displays, so the system can use fewer monitors.
In addition to hardware innovations, Azurion contains a lot of software improvements compared to other Philips angiographic systems. Thus, surgical software was completely rewritten and a new operating system called ConnectOS appeared, providing closer integration of data coming in real time from all systems of the intervention laboratory or hybrid operating system.
The new technologies implemented at Azurion work together, allowing doctors and researchers to simultaneously perform various tasks, saving time and improving the quality of patient care. As of February 2017, the system is being tested in 20 clinics.[9]
Notes
- ↑ Philips launches new Azurion neuro biplane system at #ECR2024 to speed up and improve minimally invasive diagnosis and treatment of neurovascular patients
- ↑ Philips warns on potential unintended radiation with imaging systems
- ↑ Philips warns on potential breakage issue with Allura, Azurion systems
- ↑ Philips collaborates with leading institutes to bring its breakthrough spectral CT imaging into the interventional suite
- ↑ Philips launches lung cancer diagnosis, treatment platform
- ↑ Philips unveils new version of Azurion
- ↑ Augmented reality surgical technology unveiled by Philips and Microsoft
- ↑ Philips debuts upgrade to Azurion angiography platform
- ↑ Philips launches new Azurion interventional platform
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