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Philips initiates trial to test X-ray dose technology for CAD
Philips initiates trial to test X-ray dose technology for CAD

Yahoo

time21-05-2025

  • Health
  • Yahoo

Philips initiates trial to test X-ray dose technology for CAD

Philips has initiated the randomised RADIQAL trial to assess its new ultra-low X-ray dose technology in treating coronary artery disease (CAD). According to the company, CAD is the most frequent type of heart disease worldwide. Percutaneous coronary intervention (PCI) is used to treat it, comprising a minimally invasive treatment by opening the blocked coronary arteries. Philips noted that its Azurion image-guided therapy system, which utilises live X-ray imaging during PCI, will be central to the RADIQAL trial. The multicentre trial aims to compare radiation exposure, quality of the image, and procedural performance between the company's ultra-low dose technology and the current ClarityIQ technology. These technologies are integrated into the Azurion system. It is set to enrol 824 subjects across six hospitals in the US, the Czech Republic and Spain, with the first subject enrolled at Aarhus University Hospital in Denmark. Featuring ultra-low dose protocol, the new technology aims to minimise X-ray exposure by 50% against the lowest setting on current Azurion systems with ClarityIQ. It has secured CE marking, indicating compliance with the European Union Medical Device Regulation (EU-MDR) regulatory framework. Philips image-guided therapy devices medical and clinical head Dr Darshan Doshi said: 'Reducing radiation exposure while maintaining or improving image-quality is one of the most important innovation goals in interventional cardiology.' The study will involve subject screening, baseline evaluation, randomisation, and treatment with either the Azurion system with Xres5 or control (ClarityIQ) technology. Subjects will be randomised in the intervention or control group in a 1:1 ratio. The coronary procedure will follow institutional standards, with image processing based on randomisation outcomes. Operators can switch to the standard of care imaging if necessary. In EU trial sites, primary staff will wear electronic dosimeters to log radiation exposure. Post-procedure, subject characteristics and procedure data will be recorded in an electronic case report form (eCRF), and imaging runs will be uploaded to the cloud following de-identification. The study will conclude after the coronary procedure, without altering standard treatment or follow-up of the patient. Before the RADIQAL trial, the company launched the VeriSight Pro 3D intracardiac echocardiography (ICE) catheter in Europe. "Philips initiates trial to test X-ray dose technology for CAD" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data

Philips launches RADIQAL study to generate real-world evidence for new ultra-low X-ray dose technology in coronary procedures
Philips launches RADIQAL study to generate real-world evidence for new ultra-low X-ray dose technology in coronary procedures

Yahoo

time20-05-2025

  • Health
  • Yahoo

Philips launches RADIQAL study to generate real-world evidence for new ultra-low X-ray dose technology in coronary procedures

Philips RADIQAL trial May 20, 2025 Prospective, randomized, unblinded, comparative, international, multi-center clinical investigation 824 patients across 6 hospitals in Spain, Czech Republic, Denmark and the US Primary objective is to demonstrate that the new technology can reduce overall patient radiation dose without affecting coronary procedure performance. Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced the launch of the RADIQAL (Radiation Dose and Image Quality Trial) trial. This multicenter, randomized study, sponsored by Philips will enroll 824 coronary artery disease patients across 6 hospitals in Spain, Czech Republic and the US. The first patient in the study was enrolled at Aarhus University Hospital, Denmark. 'The ability to reduce radiation exposure without compromising procedural performance is a key priority in interventional cardiology,' said Dr. Javier Escaned, Professor of Cardiology at Hospital Clínico San Carlos and principal investigator. 'It is also important to achieve high-quality angiograms when using diluted contrast media as part of ultra-low contrast procedures. RADIQAL is designed to generate robust, real-world evidence on whether Philips' new ultra-low X-ray dose technology can reduce radiation exposure for patients and staff without affecting the quality of coronary procedures.' Coronary artery disease (CAD) is the most frequent type of heart disease affecting millions of people worldwide. It is caused by chronic inflammation of the coronary arteries, which may lead to a gradual obstruction or sudden occlusion of blood flow to the heart muscle. Percutaneous coronary intervention (PCI) is a widely used image-guided, minimally invasive procedure to open blocked coronary arteries and treat CAD. Philips Azurion is an image-guided therapy system which is used for live X-ray imaging during such procedures. The RADIQAL trial evaluates radiation exposure, image quality and procedural performance between Philips' new ultra-low dose technology and existing ClarityIQ technology, both integrated into the Azurion image-guided therapy system. The new technology features an ultra-low dose protocol for coronary procedures, reducing X-ray exposure by 50% compared to even the lowest setting currently available on our Azurion systems with ClarityIQ. This technology has obtained CE marking and as such is cleared under the EU MDR regulatory framework*. 'Reducing radiation exposure while maintaining or improving image-quality is one of the most important innovation goals in interventional cardiology,' said Dr. Darshan Doshi, Head of Medical & Clinical at Philips Image-Guided Therapy Devices and Interventional Cardiologist at the Massachusetts General Hospital in Boston, USA. 'Interventional cardiologists rely on low-dose, high-quality imaging for confident decision-making throughout multiple procedures each day. Also for patients, especially those with high BMI or with complex conditions requiring repeat interventions, minimizing radiation exposure is increasingly critical.' * Not cleared as a medical device in FDA-regulated countries. Enrollment in the US has not started. For further information, please contact: Joost MalthaPhilips Global External Relations Tel.: +31 6 10 55 8116E-Mail: 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 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 2024 sales of EUR 18 billion and employs approximately 67,200 employees with sales and services in more than 100 countries. News about Philips can be found at Attachment Philips RADIQAL trial

Philips launches RADIQAL study to generate real-world evidence for new ultra-low X-ray dose technology in coronary procedures
Philips launches RADIQAL study to generate real-world evidence for new ultra-low X-ray dose technology in coronary procedures

Hamilton Spectator

time20-05-2025

  • Health
  • Hamilton Spectator

Philips launches RADIQAL study to generate real-world evidence for new ultra-low X-ray dose technology in coronary procedures

May 20, 2025 Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced the launch of the RADIQAL (Radiation Dose and Image Quality Trial) trial. This multicenter, randomized study, sponsored by Philips will enroll 824 coronary artery disease patients across 6 hospitals in Spain, Czech Republic and the US. The first patient in the study was enrolled at Aarhus University Hospital, Denmark. 'The ability to reduce radiation exposure without compromising procedural performance is a key priority in interventional cardiology,' said Dr. Javier Escaned, Professor of Cardiology at Hospital Clínico San Carlos and principal investigator. 'It is also important to achieve high-quality angiograms when using diluted contrast media as part of ultra-low contrast procedures. RADIQAL is designed to generate robust, real-world evidence on whether Philips' new ultra-low X-ray dose technology can reduce radiation exposure for patients and staff without affecting the quality of coronary procedures.' Coronary artery disease (CAD) is the most frequent type of heart disease affecting millions of people worldwide. It is caused by chronic inflammation of the coronary arteries, which may lead to a gradual obstruction or sudden occlusion of blood flow to the heart muscle. Percutaneous coronary intervention (PCI) is a widely used image-guided, minimally invasive procedure to open blocked coronary arteries and treat CAD. Philips Azurion is an image-guided therapy system which is used for live X-ray imaging during such procedures. The RADIQAL trial evaluates radiation exposure, image quality and procedural performance between Philips' new ultra-low dose technology and existing ClarityIQ technology, both integrated into the Azurion image-guided therapy system. The new technology features an ultra-low dose protocol for coronary procedures, reducing X-ray exposure by 50% compared to even the lowest setting currently available on our Azurion systems with ClarityIQ. This technology has obtained CE marking and as such is cleared under the EU MDR regulatory framework*. 'Reducing radiation exposure while maintaining or improving image-quality is one of the most important innovation goals in interventional cardiology,' said Dr. Darshan Doshi, Head of Medical & Clinical at Philips Image-Guided Therapy Devices and Interventional Cardiologist at the Massachusetts General Hospital in Boston, USA. 'Interventional cardiologists rely on low-dose, high-quality imaging for confident decision-making throughout multiple procedures each day. Also for patients, especially those with high BMI or with complex conditions requiring repeat interventions, minimizing radiation exposure is increasingly critical.' * Not cleared as a medical device in FDA-regulated countries. Enrollment in the US has not started. For further information, please contact: Joost Maltha Philips Global External Relations Tel.: +31 6 10 55 8116 E-Mail: 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 2024 sales of EUR 18 billion and employs approximately 67,200 employees with sales and services in more than 100 countries. News about Philips can be found at . Attachment

Philips launches RADIQAL study to generate real-world evidence for new ultra-low X-ray dose technology in coronary procedures
Philips launches RADIQAL study to generate real-world evidence for new ultra-low X-ray dose technology in coronary procedures

Yahoo

time20-05-2025

  • Health
  • Yahoo

Philips launches RADIQAL study to generate real-world evidence for new ultra-low X-ray dose technology in coronary procedures

Philips RADIQAL trial May 20, 2025 Prospective, randomized, unblinded, comparative, international, multi-center clinical investigation 824 patients across 6 hospitals in Spain, Czech Republic, Denmark and the US Primary objective is to demonstrate that the new technology can reduce overall patient radiation dose without affecting coronary procedure performance. Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced the launch of the RADIQAL (Radiation Dose and Image Quality Trial) trial. This multicenter, randomized study, sponsored by Philips will enroll 824 coronary artery disease patients across 6 hospitals in Spain, Czech Republic and the US. The first patient in the study was enrolled at Aarhus University Hospital, Denmark. 'The ability to reduce radiation exposure without compromising procedural performance is a key priority in interventional cardiology,' said Dr. Javier Escaned, Professor of Cardiology at Hospital Clínico San Carlos and principal investigator. 'It is also important to achieve high-quality angiograms when using diluted contrast media as part of ultra-low contrast procedures. RADIQAL is designed to generate robust, real-world evidence on whether Philips' new ultra-low X-ray dose technology can reduce radiation exposure for patients and staff without affecting the quality of coronary procedures.' Coronary artery disease (CAD) is the most frequent type of heart disease affecting millions of people worldwide. It is caused by chronic inflammation of the coronary arteries, which may lead to a gradual obstruction or sudden occlusion of blood flow to the heart muscle. Percutaneous coronary intervention (PCI) is a widely used image-guided, minimally invasive procedure to open blocked coronary arteries and treat CAD. Philips Azurion is an image-guided therapy system which is used for live X-ray imaging during such procedures. The RADIQAL trial evaluates radiation exposure, image quality and procedural performance between Philips' new ultra-low dose technology and existing ClarityIQ technology, both integrated into the Azurion image-guided therapy system. The new technology features an ultra-low dose protocol for coronary procedures, reducing X-ray exposure by 50% compared to even the lowest setting currently available on our Azurion systems with ClarityIQ. This technology has obtained CE marking and as such is cleared under the EU MDR regulatory framework*. 'Reducing radiation exposure while maintaining or improving image-quality is one of the most important innovation goals in interventional cardiology,' said Dr. Darshan Doshi, Head of Medical & Clinical at Philips Image-Guided Therapy Devices and Interventional Cardiologist at the Massachusetts General Hospital in Boston, USA. 'Interventional cardiologists rely on low-dose, high-quality imaging for confident decision-making throughout multiple procedures each day. Also for patients, especially those with high BMI or with complex conditions requiring repeat interventions, minimizing radiation exposure is increasingly critical.' * Not cleared as a medical device in FDA-regulated countries. Enrollment in the US has not started. For further information, please contact: Joost MalthaPhilips Global External Relations Tel.: +31 6 10 55 8116E-Mail: 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 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 2024 sales of EUR 18 billion and employs approximately 67,200 employees with sales and services in more than 100 countries. News about Philips can be found at Attachment Philips RADIQAL trialError in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data

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