Philips Launches RADIQAL Study to Generate Real-World Evidence for New Ultra-Low X-Ray Dose Technology in Coronary Procedures
Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, has 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, Denmark, and the US.
The RADIQAL trial aims to demonstrate that Philips’ new ultra-low X-ray dose technology can reduce overall patient radiation dose without affecting coronary procedure performance. The technology, integrated into the Azurion image-guided therapy system, features an ultra-low dose protocol that reduces X-ray exposure by 50% compared to the existing ClarityIQ technology.
“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. “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 worldwide. 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 used for live X-ray imaging during such procedures.
The new technology has obtained CE marking and is cleared under the EU MDR regulatory framework. However, it is not cleared as a medical device in FDA-regulated countries, and enrollment in the US has not started.
“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.”
For further information, please contact: Joost Maltha, Philips Global External Relations, Tel.: +31 6 10 55 8116, E-Mail: joost.maltha@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.
