Philips’ Image-guided Navigation Increases Safety During Coronary Interventions and Reduces the Use of Contrast Media by an Average of 28.8%

Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced late-breaking data from the DCR4Contrast (Dynamic Coronary Roadmap for Contrast Reduction) trial, the largest ever randomized controlled multicenter clinical trial to investigate the ability of Philips Dynamic Coronary Roadmap (DCR) to reduce the total iodinated contrast media volumes administered during percutaneous coronary intervention (PCI) procedures, compared to PCI performed without DCR guidance. The results were presented today at the European Association of Percutaneous Cardiovascular Interventions (EuroPCR) 2023 course and will also be presented later this week at the Society for Cardiovascular Angiography & Interventions (SCAI) 2023 scientific sessions.

The number of high-risk patients undergoing PCI procedures worldwide has increased significantly [2]. Iodine contrast media is used to visualize the coronary arteries during PCI procedures, but it can potentially harm the kidneys, risking the development of contrast-induced acute kidney injury (CI-AKI) after the procedure. The study found that Dynamic Coronary Roadmap reduced the total iodine contrast volume per procedure on average by 28.8% (95% Confidence Interval: 18.9%, 38.2%), and reduced the number of angiograms per procedure on average by three runs based on a procedure with an average of 11 runs or 26.3% reduction (95% Confidence Interval: 16.8%, 35.1%) [1].

“Enabling physicians to decrease contrast administration during procedures with tools like DCR could make a significant contribution to both the safety and quality of PCI.”

Prof. Javier Escaned, MD, Head of the Interventional Cardiology Section at Hospital Clinico San Carlos, Madrid Spain who presented the results today during a late-breaking session at the annual meeting for the EuroPCR 2023 (May 16-19, Paris, France).

“At Philips, we are committed to championing technologies that improve the patient’s experience, improve their safety and expand access to procedures to new patient groups. Dynamic Coronary Roadmap helps achieve these goals by structurally reducing the amount of contrast agent required for PCI procedures,” said Dr. Atul Gupta, Chief Medical Officer for Image Guided Therapy at Philips.

Multi-center, prospective, unblinded, stratified, 1:1 randomized controlled trial

The DCR4Contrast trial ran from November 2019 to February 2023 across hospitals in the U.S., Europe and Israel. In total, 371 patients were randomized and stratified within both ad hoc and planned PCI, according to the number of vessels to be treated. Patients in the DCR group underwent PCI procedures where DCR was used to guide coronary wires, balloons, stents and other PCI diagnostic or therapeutic devices. Patients assigned to the control group underwent PCI without DCR support, following the current standard of care [1].

On Thursday, May 18 Professor John C. Messenger, MD, University of Colorado School of Medicine and Director of the Cardiac Catheterization Laboratories and Cardiovascular ICU at the University of Colorado Hospital will present the data at the Society for Cardiovascular Angiography & Interventions (SCAI): “These results are very exciting,” Professor Messenger commented. “They confirm that Philips Dynamic Coronary Roadmap can be applied to all PCIs and has the potential to increase overall PCI safety by mitigating one of the few preventable contributors (iodinated contrast media use) to contrast-induced acute kidney injury following PCI.” More information on Professor Messenger’s presentation at SCAI can be found here.

Philips’ Dynamic Coronary Roadmap software is a real-time visualization innovation that removes the need for additional contrast media injections by overlaying the angiogram onto real-time motion-compensated 2D fluoroscopic imaging to provide interventionalists with continuous visual feedback on the positioning of guide wires and catheters. Complementing this technology, the Philips IntraSight precision guidance system streamlines lesion assessment, simplifies vessel sizing, enables precise therapy delivery and also supports the operator in their goal to reduce contrast volumes.

[1] Study reference number DHF287327
[2] Waldo SW, Gokhale M, O’Donnell CI, Plomondon ME, Valle JA, Armstrong EJ, Schofield R, Fihn SD, Maddox TM. Temporal Trends in Coronary Angiography and Percutaneous Coronary Intervention: Insights From the VA Clinical Assessment, Reporting, and Tracking Program. JACC Cardiovasc Interv 2018;11:879–888.

Medical Device News Magazine
Medical Device News Magazine provides our readership with breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

More News!

LumiGuide, powered by Fiber Optic RealShape (FORS) technology, enables doctors to navigate through blood vessels using light, instead of X- ray. “[It’s] one of the most exciting changes that we’ve seen with imaging certainly throughout my career,” said Andres Schanzer, Vascular Surgeon, at UMass Memorial Medical Center, Worcester, MA, USA.
Carestream Health notes twenty-seven of the patents were awarded by the U.S. Patent and Trademark Office; an additional 43 patents were received in European and Asian countries.
According to an Insightec study, patients experienced significant reductions in upper limb tremor, tremor-related disability, and quality of life. The most common intraprocedural adverse events included dizziness, headache, nausea, and vomiting, which all resolved. Post-procedural adverse events included paraesthesia and gait disturbance, which were often transient or resolved within 12 months.
Chris Landon, Business Leader Image Guided Therapy Devices at Philips: “IVUS is a technology that has demonstrated an ability to both support safer procedures for patients and procedural staff alike including reductions in radiation exposure. As the global leader in IVUS solutions, we are grateful for the rigorous multidisciplinary approach to developing expert consensus on the value of IVUS and we look forward to working with all stakeholders to standardize the use of IVUS and reduce the barriers preventing utilization.”
"We are delighted to see our 3D solution CE-marked and available on the European market," says Ulrik Harrysson, CEO at SyntheticMR AB. "SyMRI 3D represents the next generation of quantitative MRI, offering unprecedented resolution and accuracy in brain imaging, revolutionizing the landscape of medical diagnostics."

By using this website you agree to accept Medical Device News Magazine Privacy Policy

Exit mobile version