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MAASTRICHT, Netherlands, June 18, 2024 /PRNewswire/ -- Pie Medical Imaging, a global leader in cardiac imaging, announced the completion of enrollment in FASTIII, a multi-center randomized clinical trial, which investigates the use of angiography-based vessel fractional flow reserve (CAAS vFFR) in patients undergoing coronary revascularization procedures. vFFR can assess whether a coronary artery narrowing is functionally significant and may require revascularization. Continue Reading CAAS vFFR Software FASTIII is the largest non-inferiority trial running (having enrolled 2228 patients), in which an angiographically derived vFFR guided strategy is compared to a FFR guided strategy to guide coronary revascularization. The primary endpoint is a composite of all-cause death, any myocardial infarction, or any revascularization at 1-year post randomization. Following the tremendous efforts of the principal investigator, Dr Joost Daemen (cardiologist at Thoraxcenter at the Erasmus University Medical Center, Rotterdam, The Netherlands), over 35 participating centers and ECRI (sponsor of the trial), the patient enrollment has concluded. "The FASTIII trial is aimed to establish the role of vFFR to coronary revascularization in patients with intermediate coronary artery lesions. An important milestone was reached Friday, May 31st, 2024, when the last patient was enrolled", said Joost Daemen Principal Investigator of the trial. "The next phase will consist of close follow-up of all patients who generously agreed to participate in the important trial . We hope to present our findings by the end of 2025". Additionally, "PMI is committed to providing clinicians and patients with long-term coronary data to inform their treatment decisions, " said René Guillaume, Managing Director at Pie Medical Imaging. " Our prior studies have shown diagnostic accuracy and reproducibility of vFFR calculation". FASTIII will establish its role in routine clinical practice. The trial is funded by research grants from Pie Medical Imaging (Maastricht, The Netherlands) and Siemens Healthineers (Erlangen, Germany). The study is sponsored by ECRI (European Cardiovascular Research Institute, Rotterdam-the Netherlands). Cardialysis (Rotterdam, The Netherlands) is responsible for trial services including trial management and Core Laboratory activities. About Pie Medical Imaging Pie Medical Imaging BV is a world leader in analysis and visualization of cardiovascular images. In Maastricht (The Netherlands), it hosts the global sales for the CAAS and 3mensio product lines. PMI and 3mensio Medical Imaging part of the Esaote Group, leader in the biomedical equipment sector. More information about PMI is available at Photo - Logo - SOURCE Pie Medical Imaging (PMI)

MAASTRICHT, Netherlands, Jan. 20, 2023 /PRNewswire/ -- Pie Medical Imaging, a global leader in cardiac imaging, announced the 500th patient inclusion in the FAST III, a multi-center randomized clinical trial, which investigates the use of angiography-based vessel fractional flow reserve (CAAS vFFR) in patients undergoing coronary revascularization procedures. In this trial, a CAAS vFFR guided strategy is compared to a FFR guided strategy to guide coronary revascularization. The primary endpoint is a composite of all-cause death, any myocardial infarction, or any revascularization at 1-year post-randomization. Continue Reading CAAS vFFR Software Pie Medical Imaging Logo The trial, led by Dr. Joost Daemen (cardiologist at the Thoraxcenter at the Erasmus University Medical Center, Rotterdam, The Netherlands), is an investigator initiated international, multi-center randomized, non-inferiority trial. 500 patients are enrolled by hospitals with great expertise in coronary physiology at 25 sites across Europe in The Netherlands, Germany, Spain, Ireland, United Kingdom, Italy, and France. A total of 35 sites will be recruited with the final aim to include 2,228 patients by the end of the year. CAAS vFFR (Pie Medical Imaging, Maastricht, The Netherlands) is an angio-based FFR software suite to enable physiological assessment of intermediate coronary stenosis without the need of a pressure wire and adenosine. The vFFR value can be calculated with solely two angiographic projections and the aortic root pressure. This vFFR has a high correlation and diagnostic accuracy compared with wire based invasive FFR and NHPR measurements and the vFFR results are proven to be highly reproducible. "The FAST III trial, together with several other studies currently being performed with CAAS vFFR, will increase the scientific body of evidence showing that the CAAS vFFR software is an excellent alternative to invasive wire-based physiological measurements," said Rene Guillaume, Managing Director PMI. The trial is funded by research grants from Pie Medical Imaging (Maastricht, the Netherlands) and Siemens Healthineers (Erlangen, Germany). The study is sponsored by ECRI (European Cardiovascular Research Institute, Rotterdam-the Netherlands). Cardialysis (Rotterdam, The Netherlands) is responsible for trial services including trials management and Core Laboratory activities. About Pie Medical Imaging Pie Medical Imaging BV is a world leader in analysis and visualization of cardiovascular images. In Maastricht (The Netherlands), it hosts the global sales for the CAAS and 3mensio product lines. PMI and 3mensio Medical Imaging are part of the Esaote Group, leader in the biomedical equipment sector. More information about PMI is available at . Photo - Logo - SOURCE Pie Medical Imaging (PMI)

ECRI, a patient safety-focused nonprofit, recently issued an alert warning hospitals about the cybersecurity risks associated with the use of third-party analytics tools. When providers install this software on their websites and patient portals, they may be exposing patient data, ECRI warned. This exposed patient data may be misused to tailor advertisements based on consumers’ medical conditions. These inappropriately targeted advertisements could push unproven treatments and lead patients away from seeking appropriate care, according to the alert. Exposing patients’ sensitive information could also result in fines, legal action and patient distrust of providers, the alert pointed out. Hospitals are not very cognizant of the dangers associated with the use of third-party web analytic tools, Chad Waters, senior cybersecurity engineer for ECRI’s device evaluation group, told MedCity News. He said that most provider websites have multiple web analytic and tracking tools installed. “This particular issue illustrates that healthcare organizations should realize that there is more to privacy than HIPAA regulations,” Waters declared. “Analytic tools can infer sensitive health information from a user’s browsing activities on a provider’s site regardless of whether or not it is protected health information. Providers should consider their role in protecting patient privacy in that broader scope.” Some common examples of third-party analytics software used by providers include Google Analytics, Adobe Analytics and Meta Pixel. These tools are usually free and can give providers insight into the way consumers use their websites, but the tech companies who provide this software can also use patient data to profile Internet users as they browse. This is not the first time concerns have been raised about providers’ use of Meta Pixel. ECRI’s alert referenced a June report from The Markup, which said that the tool exposed appointment scheduling information to Meta when providers used it within their Epic MyChart patient portals. Additionally, Advocate Aurora Health, a health system based in Wisconsin and Illinois, recently disclosed a data breach that involved Meta Pixel. In a statement the health system posted last month, it said it had disabled the software. But a patient affected by Advocate Aurora Health’s breach has sued the health system in a class-action lawsuit. In his complaint, he claimed his private information was shared with Meta in a breach that could have affected three million patients. ECRI’s alert encouraged hospitals to scrutinize their use of analytics tools more closely, as well as establish policies and best practices when deploying these tools. “It is important to understand that many of these tools are free because their revenue model is dependent on building profiles of Internet users,” Waters said. “There are web analytic tools that do not use that model. Hospitals should review usage policies and be cautious on where these tools are deployed.”