Coronary suite

Coronary suite

Transforming complex PCI procedures into confident care

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    Complex PCI cases are becoming more common, leading to a higher risk of adverse events.1

    Procedural guidance and vessel preparation tailored to the patient’s needs may help you overcome some of the challenges of complex PCI and achieve better outcomes.

     

    Philips Coronary suite offers a range of specialty coronary diagnostic and therapy tools that enable safe and effective treatment.

     

    With an outstanding user experience and clinical excellence, we provide you with the solutions that allow you to treat complex PCI more confidently.

    See clearly. Treat optimally.

    See clearly treat optimally

    Philips is focused on helping physicians improve outcomes for complex PCI procedures
     

    • Stay focused on your patient and the task at hand with enhanced user controls and simplified workflow
    • Easily access all modalities needed for treating complex PCI through an intuitive touch screen
    • Innovate your procedures with best-in-class diagnostic tools like Dynamic coronary roadmapping, iFR, IVUS and co-registration
    • Built for today’s lab and ready for tomorrow, Coronary suite is a foundational platform designed to meet the evolving needs of the lab

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    Explore Coronary suite benefits

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    Stay focused on your patient and the task at hand with the outstanding user experience of Coronary suite


    According to Healthcare Information and Management Systems Society, “The User Experience in healthcare is an increasingly important topic due to the increasing array of systems, devices, patients and providers that interact to diagnose, treat and manage disease".

    "Improving the user experience for clinicians is of utmost importance due to its impact on patient care as well as physician and clinician satisfaction."2

    Award-winning design of Azurion

    Azurion achievement
    This design is really the right direction to move forward, so sophisticated!

    Y. Kashima, Executive Director and Vice President, Sapporo Heart Center, Japan

    Interventional Hemodynamic system

    88%
    of the users believe
    the system can be
    confidently used by

    all staff members
    with minimal
    training

    Philips Intervenional Hemodynamic system brings advanced hemodynamic measurements into the interventional lab to support clinical decision making.
    Interventional hemodynamic system
    88% of the users believe the system can be confidently used by all staff members with minimal training
    Philips Intervenional Hemodynamic system brings advanced hemodynamic measurements into the interventional lab to support clinical decision making.

    At Philips we designed the Azurion image guided therapy platform by partnering with clinicians and hospitals all over the world. Usability studies by an independent agency demonstrated excellent usability scores and recognized the system’s efficiency improvement features. With a System Usability Score (SUS) of 87 and 5 prestigious design awards, the Azurion platform has been recognized for providing an

    outstanding user experience.

    Easily navigate even the most complex cases with IntraSight

    IntraSight
    Play
    IntraSight provides a simple, intuitive interface that minimizes learning curves and increases workflow confidence. Streamline procedures with automated workflows for both iFR and IVUS co-registration3. The all new demonstration mode for IntraSight facilitates faster training without using a catheter or wire.

    Fast, plug-and-play digital IVUS only offered by Philips

    Plug and play
    The plug-and-play simplicity of the Eagle Eye Platinum digital IVUS catheter provides a fast, easy approach for IVUS guided PTCA. There is no motor drive, no moving parts, and no pullback device required. Additionally, you don’t have to worry about flushing or priming the transducer before a procedure. Eagle Eye Platinum is the #1 choice of physicians for intravascular imaging4.

    Discover what improved lab performance can do for you


    Save time and money on complex PCI procedures with the unique workflow and treatment strategies offered by our Coronary suite, proven to reduce costs and procedure time, while increasing workflow flexibility in the cath lab.

    Philips’ iFR reduces procedural costs and time versus FFR8,9

    Reduced costs per patient8

    DEFINE FLAIR and iFR Swedeheart found that on average, compared to FFR, iFR resulted in:
    Cost reduction
    The FlexVision Pro is fantastic! I can control everything from table side without sterility breaks.”

    Improve workflow for radial access with FlexArm

    FlexVision pro
    Play

    The Azurion with FlexArm enables off-center coronary imaging to perform radial access without moving the patient or pivoting the table. This can save time and enhance visualization for complex PCI procedures that may require multiple access points. An independent user study showed 91% reduction in table positioning movements, from 19.4 to 1.8 on average, in procedures that include table pivots, such as radial access procedures, compared to the Philips Azurion 7 C20 system.
    The evidence-based iFR modality enables you to quickly assess ischemia in as few as five heartbeats. Cost effectiveness analysis of DEFINE FLAIR demonstrates a per patient annual cost reduction of $896 for the U.S. system when using iFR compared to FFR. An iFR-guided strategy resulted in 10% reduction in procedural time.8,9

    Ability to treat one more patient per day, today or in the future with Azurion7

    Ability to treat one more patient per day
    This is just one of the many improvements in lab performance achieved by the Interventional Vascular Department at St. Antonius Hospital after installing the Azurion interventional X-ray system. Its flexible workspots and Instant Parallel Working support multidisciplinary teams in working faster and more efficiently leading to 17% reduction in procedure time.

    Seamless integration of IntraSight to improve cath lab workflow

    Seamless integration
    Play
    The IntraSight interventional applications platform has an all new touch screen control module (TSM) that offers more control within the sterile field. Run an entire case from tableside without breaking scrub as you quickly navigate, annotate and measure to your exact specifications. Increase case efficiency, save time and reduce errors with streamlined data flow and case management.

    Explore specialty coronary tools to help you provide superior care


    At Philips, we shifted from focusing on the technology in the cath lab, to innovating the interventional procedure to improve outcomes for patients with specific diseases. The Coronary suite empowers you to decide, guide, treat and confirm during PCI procedures and to have a positive impact on your patient's lives.

    Decide not just whether to treat, but where to treat

    Decide not just whether to treat
    Play

    Combine iFR and IVUS data with the angiogram for optimal treatment outcomes using Philips’ exclusive iFR and IVUS Co-registration3 technology. iFR Co-registration maps iFR values directly onto the angiogram, allowing you to see precisely which parts of a vessel are causing ischemia. Before a stent is even placed, use virtual stenting to easily get a length measurement.

     

    IVUS Co-registration maps the 3D vessel anatomy to the angiogram to understand precisely where the disease begins and ends for accurate stent sizing and placement, helping to avoid geographic miss.

    Proven outcomes. Superior value

    Arrow

    iFR Swedeheart reported that with no hyperemic agent, you can achieve a  95.7% reduction in patient discomfort using an iFR-guided strategy

    DEFINE FLAIR reported a 90% reduction in patient discomfort

     Scales
    iFR is the leading hyperemia-free physiologic index for measuring pressure in diagnostic and interventional PCI procedures. Only offered by Philips, iFR is an evidence-based methodology that improves outcomes, saves time, and reduces patient discomfort.10,11,12 Only iFR has clinically validated outcome data in the largest physiology studies ever conducted.8,9 No other resting index has patient outcome data to support it's use.

    Real-time guidance designed to improve efficiency of coronary procedures

    Real-time guidance
    Play
    Dynamic Coronary Roadmap, a Philips-exclusive technology, creates a motion-compensated, real-time view of coronary arteries. A highlighted coronary angiogram is superimposed on a live 2D fluoroscopic image, creating a colored roadmap that adjusts automatically, providing continuous visual feedback on positioning of wires and catheters.

    High safety. Low radiation

    High safety
    In routine coronary procedures,16 ClarityIQ technology may reduce patient radiation dose (as total dose-area product) by 67%18 for the total procedure without affecting the procedural performance (fluoroscopy time and number of exposure images) as compared to equivalent procedures on an Allura Xper system, as demonstrated in one single-center study.18

    Prepare to succeed in complex PC

    Prepare to succeed in complex PCI
    Certain patient and lesion types are at greater risk for poor vessel compliance and inadequate stent expansion. Plaque modification to improve vessel compliance helps enable full stent expansion, which is related to a reduction in future restenosis and thrombosis.13 Prepare the vessel with ELCA14 coronary laser atherectomy and Angiosculpt PTCA15 scoring balloon. AngioSculpt PTCA scoring balloon is the only specialty scoring device indicated for ISR and complex type C lesions. ELCA coronary laser helps to cross occluded arteries and modify the most challenging morphologies with a safe and easy to use system.

    Key products of Coronary suite

    Azurion system

    Azurion

     

    Experience the new world of interventional cardiac and vascular performance with the Azurion 7 Series with 12'' flat detector.

    IntraSight

    IntraSight

     

    The IntraSight applications platform is where imaging, physiology, co-registration3 and software all come together to clearly identify coronary and peripheral artery disease, and allow for more optimized treatment plans.

    iFR clinical outcomes

    iFR clinical outcomes

     

    iFR is the gold standard among resting indices backed by patient outcomes that reduces costs, procedural time and patient discomfort9,10,11 while providing advance guidance with co-registration.

    Integrated cardiology solutions

    Integrated cardiology solutions

     

    Explore an integrated cardiology ecosystem of data and devices working together to help you provide efficient and effective cardiac care in the most appropriate setting.

    References

    1. Witzenbichler B et al. Relationship Between Intravascular Ultrasound Guidance and Clinical Outcomes After Drug-Eluting Stents: The ADAPT-DES Study. Circulation 2014 Jan: 129,4;463-470. 

    2. www.himss.org/user-experience-ux-healthcare-it

    3. Co-registration tools available within IntraSight 7 configuration via SyncVision.

    4. Millenium Research Group, US Marketrack internal sales data on file

    5. Results obtained during usability study performed in December 2016. The study involved 33 participants. Participants were spread evenly over technologist/nurses and physicians. To evaluate benefits of the multi-user capabilities of the new system design and user satisfaction, its novel design was tested by participants that had relevant working experience in the interventional lab and who had not previously used the new system. 

    6. Results obtained during user tests performed in 2017/2018 by Philips Healthcare and Use-Lab GmbH, an independent company. The tests involved 17 physicians from Europe and the USA, who performed simulated procedures in a simulated OR environment.

    7. Results are specifific to the institution where they were obtained and may not reflflect the results achievable at other institutions. Results obtained by the Interventional Vascular Department at St. Antonius Hospital. 

    8. Patel M. “Cost-effectiveness of instantaneous wave-Free Ratio (iFR) compared with Fractional Flow Reserve (FFR) to guide coronary revascularization decision making.” Late-breaking Clinical Trial presentation at ACC on March 10, 2018. 

    9. Davies JE, et al., Use of the Instantaneous Wave-free Ration or Fractional Flow Reserve in PCI. N Engl J Med. 2017 May 11;376(19):1824-1834. 

    10. Davies JE, et al., DEFINE-FLAIR: A Multi- Centre, Prospective, International, Randomized, Blinded Comparison of Clinical Outcomes and Cost Effifficiencies of iFR and FFR Decision-Making for Physiological Guided Coronary Revascularization. New England Journal of Medicine, epub March 18, 2017. 

    11. Gotberg M, et al., Instantaneous Wave-Free Ratio Versus Fractional Flow Reserve Guided Intervention (IFR-SWEDEHEART): A Multicenter, Prospective, Registry-Based Randomized Clinical Trial. New England Journal of Medicine, epub March 18, 2017. 

    12 Patel M. “Cost-effectiveness of instantaneous wave-Free Ratio (iFR) compared with Fractional Flow Reserve (FFR) to guide coronary revascularization decision-making.” Late-breaking Clinical Trial presentation at ACC on March 10, 2018. 

    13. Virmani R, Farb A, Burke AP. Coronary angioplasty from the perspective of atherosclerotic plaque: Morphologic predictors of immediate success and restenosis. Am Heart J. 1994;127:163–79. 

    14. The Excimer laser coronary atherectomy catheters (ELCA) are used in conjunction with the Spectranetics CVX-300 Excimer laser system and are intended for use in patients with a variety of blockages in single or multivessel coronary artery disease. ELCA is usually used in conjunction with other therapies, such as balloon angioplasty or stenting. The use of ELCA may be unsafe in some patients or in treating certain types of blockages. The ELCA X-80 catheter should not be used in patients with weakened heart muscles (ejection fraction <30%) or in cases of acute heart attacks. Rarely a patient undergoing ELCA may require urgent surgical treatment for a complication; therefore, patients who are not candidates for coronary bypass graft surgery should not undergo treatment with ELCA. Ask your doctor if you are a candidate for ELCA. Potential adverse events ssociated with procedures used to treat coronary artery disease may include: a tear, rupture, damage to the artery; a sudden, temporary or ongoing re-closure of the treated artery; blood clot or obstruction of the artery by plaque debris. Other complications may occur. Rare but serious potential adverse events include: the need for urgent additional procedures or surgery due to bleeding, vascular damage, loss of blood flow or other complications; and irregular heartbeat, heart attack or death. This information is not intended to replace a discussion with your healthcare provider on the benefits and risks of this procedure to you.  The AngioSculpt scoring balloon catheter is indicated for use in the treatment of hemodynamically signifificant coronary artery stenosis, including in-stent restenosis, for the purpose of improving myocardial perfusion.

    15. The AngioSculpt catheter should not be used for coronary artery lesions unsuitable for treatment by percutaneous revascularization, and coronary artery spasm in the absence of a significant stenosis. Possible adverse effects include, but are not limited to: death; heart Attack (acute myocardial infarction); total occlusion of the treated artery; coronary artery dissection, perforation, rupture, or injury; pericardial tamponade; no/slow reflflow of treated vessel; emergency coronary artery bypass (CABG); emergency percutaneous coronary intervention; CVA/ stroke; pseudoaneurysm; restenosis of the dilated vessel; unstable chest pain (angina); thromboembolism or retained device components; irregular heart rhythm (arrhythmias, including life-threatening ventricular fibrillation); severe low (hypotension)/high (hypertension) blood pressure; coronary artery spasm; hemorrhage or hematoma; need for blood transfusion; surgical repair or vascular access site; creation of a pathway for blood flflow between the artery and the vein in the groin (arteriovenous fifistula); drug reactions, allergic reactions to x-ray dye (contrast medium); and infection. This information is not intended to replace a discussion with your healthcare provider on the benefits and risks of this procedure to you. 

    16. Routine coronary interventions comprise of fluoroscopy and exposure usage. 

    17. 95% CI of 53%, 77% for all diagnostic and interventional coronary procedures. The results of the application of dose reduction techniques will vary depending on the clinical task, patient size, anatomical location and clinical practice. The interventional cardiologist assisted by a physicist as necessary has to determine the appropriate settings for each specific clinical task. 

    18. Results based on total dose area product from a single center prospective controlled randomized study (University Hospital Ghent, Belgium) on 122 patients (42 for Allura Xper and 80 for AlluraClarity) undergoing coronary procedures. Of the 122 patients, 102 (83.6%) had a diagnostic procedure without intervention and 51 (41.8%) resulted in a diagnosis of no coronary disease. Patient radiation exposure was quantified using cumulative dose area product as collected from Radiation Dose Structured Reports and/or Allura Reports. Baseline dose was maintained by confifiguring both systems to power up with the lowest dose settings as default and default procedure settings for cardio were used. Exam duration and fluoro time was consistent between the systems and an increase in number of exposure images and runs with the AlluraClarity was attributed to the biplane configuration compared to the monoplane configuration of the Allura Xper.

    ELCA

    The Excimer laser coronary atherectomy catheters (ELCA) are used in conjunction with the Spectranetics CVX-300 Excimer laser system and are intended for use in patients with a variety of blockages in single or multivessel coronary artery disease. ELCA is usually used in conjunction with other therapies, such as balloon angioplasty or stenting. The use of ELCA may be unsafe in some patients or in treating certain types of blockages. The ELCA X-80 catheter should not be used in patients with weakened heart muscles (ejection fraction <30%) or in cases of acute heart attacks. Rarely a patient undergoing ELCA may require urgent surgical treatment for a complication; therefore, patients who are not candidates for coronary bypass graft surgery should not undergo treatment with ELCA. Ask your doctor if you are a candidate for ELCA. Potential adverse events associated with procedures used to treat coronary artery disease may include: a tear, rupture, damage to the artery; a sudden, temporary or ongoing re-closure of the treated artery; blood clot or obstruction of the artery by plaque debris. Other complications may occur. Rare but serious potential adverse events include: the need for urgent additional procedures or surgery due to bleeding, vascular damage, loss of blood flflow or other complications; and irregular heartbeat, heart attack or death. This information is not intended to replace a discussion with your healthcare provider on the benefits and risks of this procedure to you.

     

    AngioSculpt PTCA

    The AngioSculpt scoring balloon catheter is indicated for use in the treatment of hemodynamically significant coronary artery stenosis, including in-stent restenosis, for the purpose of improving myocardial perfusion. The AngioSculpt catheter should not be used for coronary artery lesions unsuitable for treatment by percutaneous revascularization, and coronary artery spasm in the absence of a signifificant stenosis. Possible adverse effffects include, but are not limited to: death; heart Attack (acute myocardial infarction); total occlusion of the treated artery; coronary artery dissection, perforation, rupture, or injury; pericardial tamponade; no/slow reflow of treated vessel; emergency coronary artery bypass (CABG); emergency percutaneous coronary intervention; CVA/ stroke; pseudoaneurysm; restenosis of the dilated vessel; unstable chest pain (angina); thromboembolism or retained device components; irregular heart rhythm (arrhythmias, including life-threatening ventricular fifibrillation); severe low (hypotension)/high (hypertension) blood pressure; coronary artery spasm; hemorrhage or hematoma; need for blood transfusion; surgical repair or vascular access site; creation of a pathway for blood flow between the artery and the vein in the groin (arteriovenous fistula); drug reactions, allergic reactions to x-ray dye (contrast medium); and infection.

     

    This information is not intended to replace a discussion with your healthcare provider on the benefits and risks of this procedure to you.

     

    Prescription Use Statement

    Caution: Federal law restricts this device to sale by or on the order of a physician

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