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Philips introduces integrated Interventional Hemodynamic System with Patient Monitor IntelliVue X3 to improve workflow and patient focus during image-guided procedures at ACC.21

May 14, 2021

Continuous monitoring provides informed, timely clinical decision making and comprehensive, gap-free patient records in the cath lab and beyond

Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced the integration of its Interventional Hemodynamic System and market-leading portable Patient Monitor IntelliVue X3, providing advanced hemodynamic (blood flow) measurements at the tableside in the cath lab and continuous monitoring of key vital signs throughout the patient journey [1]. The integration provides the opportunity for monitoring during image-guided procedures on the Philips Image Guided Therapy System – Azurion, improving workflow with comprehensive patient records that support timely clinical decision-making during interventional cardiology procedures and beyond. The solution will be introduced at ACC.21, the American College of Cardiology’s 70th Annual Scientific Session and Expo, taking place virtually on May 15-17.

Health systems strive to deliver consistent quality patient care while optimizing the interventional room to treat more patients and accelerate care of the critically ill. Uninterrupted patient monitoring, as patients are moved from holding areas to the interventional room and then on to recovery areas, can help to improve clinical decision making and the timely detection of potential adverse events at every stage of the patient journey. Incorporating a 12-lead diagnostic ECG, the monitor removes the need to re-cable the patient or reconnect monitoring, and can help lead to reduced procedural preparation time, enhanced staff efficiency and ultimately an enhanced patient experience.

“Philips Interventional Hemodynamic System with Patient Monitor IntelliVue X3 is a unique combination made possible by our strengths in patient monitoring and image-guided therapy,” said Ronald Tabaksblat, General Manager Image Guided Therapy Systems at Philips. “Bringing advanced hemodynamic measurements to the tableside as an integrated part of our Azurion image-guided therapy system, it helps allow clinicians to assess the condition of the patient in real time during an intervention, without leaving the sterile field. It also streamlines workflows, providing continuous monitoring of the patient during every step of their care path, enhancing patient safety and confidence.”

The IntelliVue X3 patient monitor can be connected to the patient from anywhere in the hospital, after which it stays with them throughout the interventional procedure, providing continuous monitoring and registration of their vital signs in the IntelliVue IT solution.

After connecting the IntelliVue X3 to its docking station at the tableside of the Azurion system, clinical staff can monitor all of the patient’s vital signs including pulse oximetry end-tidal CO2, perform hemodynamic analyses and 12-lead ECG acquisitions, and relay results and waveforms from the lab’s control room to the Azurion tableside display. From the tableside the interventionalists can assess the data using the Azurion tableside Touch Screen Module, allowing them to remain focused on their patients. The system brings the latest physiological techniques to the interventional lab, including iFR (instant wave-Free Ratio) measurements, a hyperemia-free technique unique to Philips that provides valuable functional information regarding the severity of lesions in the coronary arteries.

Philips Interventional Hemodynamic System with Patient Monitor IntelliVue X3 integrates with Azurion, the company’s next-generation image-guided therapy system that allows clinicians to easily and confidently perform procedures with a unique user experience, helping to optimize lab performance and provide superior care. At ACC.21 Philips will showcase its solutions for the diagnosis and treatment of Structural Heart Disease, which aim to remove the barriers associated with complex procedures by helping to deliver clinical confidence where it is needed most – at the point of treatment. Philips’ cardiac care solutions help strengthen clinical confidence, build efficiency throughout the care pathway, and enhance care experiences. For more information visit www.philips.com/acc.

[1] Philips Interventional Hemodynamic System with Patient Monitor IntelliVue X3 is available in the majority of markets worldwide. Philips’ continuous patient monitoring solution is available for sale in markets across Europe, Middle East and APAC, with further expansion planned later this year. It is not available for sale in the U.S.

For further information, please contact:

Mark Groves
Philips Global Press Office
Tel: +31 631 639 916
Email: mark.groves@philips.com

Anna Hogrebe
Philips Global Press Office
Tel.: +1 416 270 6757
Email: anna.hogrebe@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, and enabling better outcomes across the health continuum – from healthy living and prevention, to diagnosis, treatment and home care. Philips leverages advanced technology and deep clinical and consumer insights to deliver integrated solutions. Headquartered in the Netherlands, the company is a leader in diagnostic imaging, image-guided therapy, patient monitoring and health informatics, as well as in consumer health and home care. Philips generated 2020 sales of EUR 17.3 billion and employs approximately 77,000 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter.

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PRA Health Sciences pioneers connecting clinical trial patients with their real-world data with Synoma

Pharmaceutical, biotech and other research sponsors can now connect their clinical studies to longitudinal real-world data – speeding up drug development and aligning with the 21st Century Cures Act.

RALEIGH, N.C., May 13, 2021 (GLOBE NEWSWIRE) — PRA Health Sciences, Inc. (NASDAQ: PRAH) announced today an innovative tokenization solution using Synoma®, PRA’s proprietary technology that allows for the generation of enhanced evidence for drug development. PRA’s solution makes it possible to connect clinical trial data and secondary data sets with privacy at the forefront. Today, three large pharmaceutical companies, along with several other pharmaceutical and biotech companies of all sizes, are using Synoma to link data and conduct analyses across their drug development portfolios.

“Data of all types is widely available from dozens of sources. The missing link, however, is the ability to connect clinical trial data to the insights from real-world data – enabling researchers to understand what is happening outside and after a study in a way that protects privacy,” said Kent Thoelke, Executive Vice President and Chief Scientific Officer, PRA Health Sciences. “Tokenization and linking is the approach researchers can use to glean the greatest insights into drug safety and effectiveness over time.”

PRA can partner with a variety of tokens to multiple sources of information – making it possible to incorporate broader sets of real-world data and revolutionize evidence generation and insights as envisioned by the 21st Century Cures Act.

“Tokenization of siloed patient data sets will be a game-changer for clinical researchers and drug developers,” said Jane Quigley, Senior Vice President, Digital Health, PRA Health Sciences. “Through our acquisition of Symphony Health and partnership with other data sources, we have enabled scientists and research teams to more intelligently evaluate a wider set of data to inform clinical trial protocols, leverage real-world data as eSource, conduct advanced feasibility, speed enrollment and, ultimately, bring novel and differentiated therapies to market faster.”

Contact us to learn more about how Synoma can be applied to clinical studies.

About PRA Health Sciences

PRA Health Sciences is one of the world’s leading global contract research organizations by revenue, providing outsourced clinical development and data solution services to the biotechnology and pharmaceutical industries. PRA’s global clinical development platform includes more than 75 offices across North America, Europe, Asia, Latin America, Africa, Australia and the Middle East and more than 19,000 employees worldwide. Since 2000, PRA has participated in approximately 4,000 clinical trials worldwide. In addition, PRA has participated in the pivotal or supportive trials that led to U.S. Food and Drug Administration or international regulatory approval of more than 95 drugs. To learn more about PRA, please visit www.prahs.com.

INVESTOR INQUIRIES: InvestorRelations@prahs.com

MEDIA INQUIRIES: Laurie Hurst, Sr. Director, Communications and Public Relations

hurstlaurie@prahs.com | +1 (919) 786-8435

Align Technology Supports the United Kingdom’s General Dental Council (GDC) Statement on Direct-to-Consumer Orthodontics which Highlights Patient Safety Issues

Updated GDC Policy Statement Affirms Requirement and Importance of a Physical Examination for Orthodontic Treatment and for Patients to Know the Full Name of the Dental Professional Responsible for their Orthodontic Treatment

BIRMINGHAM, United Kingdom and TEMPE, Ariz., May 13, 2021 (GLOBE NEWSWIRE) — Align Technology, Inc. (Nasdaq: ALGN), a leading global medical device company that designs, manufactures, and sells the Invisalign system of clear aligners, iTero intraoral scanners, and exocad CAD/CAM software for digital orthodontics and restorative dentistry, today announced its support for an updated policy statement issued by the General Dental Council (GDC), the UK-wide statutory regulator of general dentist practitioners and dental care professionals.

In the updated statement [LINK: https://www.gdc-uk.org/news-blogs/news/detail/2021/05/13/statement-on-direct-to-consumer-orthodontics-and-supporting-information], the GDC affirms that orthodontic treatment must be based on a full assessment of a patient’s oral health that includes a physical, clinical examination prior to commencement of treatment. The statement also highlighted the critical importance of direct interaction between a patient and practitioner, for patients to know the full name of the dental professional responsible for their treatment and to be able to make direct contact with the doctor treating them.

“We applaud the GDC for its important role in regulating dental care, guarding the standards for responsible dentistry in the UK, and for providing resources to help dentists support their patients and make informed decisions about dental care,” said Julie Coletti, Align Technology senior vice president, chief legal and regulatory officer. “We know that orthodontic treatment should always be prescribed and delivered by a doctor who is best qualified to assess and plan clinical treatments based on an in-person exam.”

About Align Technology, Inc.

Align Technology designs, manufactures and offers the Invisalign system, the most advanced clear aligner system in the world, iTero intraoral scanners and services, and exocad CAD/CAM software. These technology building blocks enable enhanced digital orthodontic and restorative workflows to improve patient outcomes and practice efficiencies for over 200 thousand doctor customers and is key to accessing Align’s 500 million consumer market opportunity worldwide. Align has helped doctors treat over 10.2 million patients with the Invisalign system and is driving the evolution in digital dentistry through the Align Digital Platform, our integrated suite of unique, proprietary technologies and services delivered as a seamless, end-to-end solution for patients and consumers, orthodontists and GP dentists, and lab/partners. Visit www.aligntech.com for more information.

For additional information about the Invisalign system or to find an Invisalign doctor in your area, please visit www.invisalign.com. For additional information about the iTero digital scanning system, please visit www.itero.com. For additional information about exocad dental CAD/CAM offerings and a list of exocad reseller partners, please visit www.exocad.com.

Align Technology Zeno Group
Madelyn Homick Sarah Johnson
(408) 470-1180 (828) 551-4201
mhomick@aligntech.com sarah.johnson@zenogroup.com