Highlighted products for this procedure

Azurion 7 C12 with FlexVision

Azurion

Compact system design

Lab integration with single touch screen control of IntraSight, hemodynamic monitoring and other Philips' applications

Instant Parallel Working, perform tasks such as 2D-QA during fluoroscopy or exposure

With the Azurion image-guided therapy platform, your medical teams can benefit from a seamless user experience and the simplicity of touch screen control that can improve cath lab workflow. Table side control saves you from going to the control room to access applications. Smart solutions, like ClarityIQ and Zero Dose Positioning, provide efficient dose management. This response helps to support a growing demand for enhanced patient and employee safety.
Azurion 7 C20 with FlexArm

IntraSight interventional applications platform

Philips IntraSight offers you a comprehensive suite of clinically proven1-5 imaging, physiology and co-registration6 tools on a modern, secure platform that will help you simplify complex interventions, speed routine procedures and improve lab efficiencies. These best-in-class interventional tools ultimately allow you to go beyond the angiogram and complete your view of the target vessel so you can make fast, informed clinical decisions. IntraSight is built on a modern, scalable platform that will be ready to provide you with new innovations and tools as they become available in the future. IntraSight can be integrated in any cath lab with or with Azurion
Hemo with IntelliVue X3 workstation

Philips Hemo system with IntelliVue X3 & Xper Information Management

Philips introduces the Interventional Hemodynamic system (Philips Hemo system) which brings advanced hemodynamic measurements to the cath lab. Integrated with the market leading Philips IntelliVue X3 patient monitor, this unique combination enables continuous patient monitoring throughout the cath lab. By connecting the IntelliVue X3 in the cath lab with the Philips Hemo system, you can continuously monitor a patient.

Xper IM is designed to enable more efficient cath lab workflows with hemo monitoring and data management. It streamlines workflows in physician reporting, billing, registry reporting and inventory management.

IntraSight has made an immediate impact in our lab. It’s so simple and intuitive to use that it took us no time at all to get used to it. It has made using physiology and imaging even quicker and easier which is a great advance for us and for our patients.”

Dr. Rasha Al-Lamee

Imperial College London, Hammersmith Hospital

Operational availability icon

135

more hours of operational availability
135 more hours in average of operational availability per year.12 Gain time to treat more patients in your interventional suite.
Improve usability icon

91%

agree that the new touch screen module improves usability
91% of Azurion users think the enhanced touch screen module technology increases the ease of use when switching between compatible applications (e.g., X-ray, IFR/FFR, IVUS, hemo, etc.) during interventions compared to their current system.13 
Cost reduction icon

$ 896

dollars saved
Philips iFR provides $896 cost saving compared to FFR.3

    See clearly. Treat optimally.

    dynamic coronary roadmap

    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.

    StentBoost live

    StentBoost Live
    StentBoost Live quickly helps you verify positioning before and after deploying balloons, stents, and intra-coronary devices to display under deployment and confirm full expansion. And it’s all done in real-time, so you no longer need to wait for new images before you reposition.

    IntelliSpace cardiovascular

    IntelliSpace Cardiovascular
    ISCV is designed to streamline workflow throughout the cardiovascular care continuum. Providing a single point of access anytime and virtually anywhere to support informed decision-making. It can be viewed and controlled from the FlexSpot and FlexVision Pro of Azurion, allowing for easy intra-procedural check of pre-operative information.

    Intravascular ultrasound (IVUS) modality

    Intravascular Ultrasound (IVUS)
    Optimize patient outcomes by using a standardized IVUS criteria. Compared to angiography-guided PCI alone, in all comer patients, ULTIMATE shows that IVUS-guided PCI significantly reduces clinically driven target lesion revascularization (TLR). This benefit was sustained over three years. Only 1.6% target vessel failure (TVF) at 12 months and 4.2% TVF at 3 years when optimal IVUS-guided PCI criteria was met.

    iFR (physiology) modality

    iFR modality
    iFR is the leading hyperemia-free physiologic index for measuring pressure in diagnostic and interventional procedures that is recognized by key cardiovascular societies8,9 Only iFR has clinically validated patient outcome data in the largest physiology studies ever.2,10 iFR Co-registration maps the physiologic measurements, directly onto the angiogram enabling more complete procedural guidance.
    ELCA coronary laser atherectomy catheter

    ELCA coronary laser atherectomy catheter

    Designed to cross, prepare and treat the most complex coronary lesions. This non-mechanical atherectomy catheter can be delivered over any .014” wire and can de-bulk and modify plaque of multiple morphologies and is approved for the broadest range of coronary indications in atherectomy.
    AngioSculpt

    AngioSculpt RX PTCA scoring balloon catheter

    Significantly alters the landscape for treating CAD, offering the advanced performance that only an innovative clinical solution can provide. The AngioSculpt RX PTCA scoring balloon catheter is the only specialty scoring device indicated for ISR and complex type-C lesions.
    OmniWire pressure guide wire

    OmniWire pressure guide wire

    World’s first solid core pressure guide wire. With an all new workhorse design, only Philips OmniWire pressure guide wire combines confidence in wire performance with proven iFR outcomes and iFR Co-registration, making it easy to benefit from physiology throughout the case.2,10,11

    Do you want to know more?

    IVUS expert ipad

    Become an IVUS expert


    Advance your IVUS imaging skills with interactive workflows and detailed image interpretation practice. The Philips Coronary IVUS Tutor app is free to download in the App Store or Google Play.
    Cardio app

    Practice using IVUS in cases


    Experience the interactive educational app CardioEx which now features new cases on Philips IVUS, physiology and co-registration. Cardio Ex app is free to download in the App Store or Google Play.
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    How would you improve coronary procedures?

     

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    News and blogs on image-guided therapy

    Disclaimers

    Product availability is subject to country regulatory clearance. Please contact your local sales representative to check the availability in your country.

     

    ELCA important safety information 

    Indications: The laser catheters are intended for use either as a stand-alone modality or in conjunction with percutaneous transluminal coronary balloon angioplasty (PTCA) in patients who are acceptable candidates for coronary artery bypass graft (CABG) surgery. The following indications for use, contraindications and warnings have been established through multicenter clinical trials. The Philips CVX-300 Excimer laser system and the multi-fiber laser catheter models are safe and effective for the following indications: occluded saphenous vein bypass grafts, ostial lesions, long lesions (greater than 20mm in length), moderately calcified stenosis, total occlusions traversable by a guidewire, lesions which previously failed balloon angioplasty, restenosis in 316L stainless steel stents, prior to the administration of intravascular brachytherapy. These lesions must be traversable by a guidewire and composed of atherosclerotic plaque and/or calcified material. The lesions should be well defined by angiography. 

    Contraindications: Lesion is in an unprotected left main artery. Lesion is beyond acute bends or is in a location within the coronary anatomy where the catheter cannot traverse. Guidewire cannot be passed through the lesion. Lesion is located within a bifurcation. Patient is not an acceptable candidate for bypass graft surgery. 

    Potential adverse events: Use of the Philips CVX-300 Excimer laser system may contribute to the following complications: dissection of the arterial wall, perforation, acute reclosure, embolization, aneurysm formation, spasm, coronary artery bypass graft surgery, thrombus, myocardial infarction, arrhythmia, filling defects, death. No long term adverse effects of ELCA are known at this time. 

    Risks: The primary endpoint defined in the laser angioplasty of restenosis stents (LARS) randomized trial was the absence of major adverse cardiac events (MACE) at 6 months: Death; myocardial infarction; coronary artery bypass surgery. Procedural complications include: any dissection, acute thrombus, haziness, no reflow, arrhythmia, acute vessel closure, occlusion of side branch, occlusion non-target, coronary spasm, coronary embolism, coronary perforation, laser/stent damage, balloon/stent damage, and other serious. 

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

     

    AngioSculpt RX PTCA scoring balloon catheter

    Indications

    The AngioSculpt scoring balloon catheter is indicated for use in the treatment of hemodynamically significant coronary artery stenosis, including in-stent restenosis and complex type C lesions, for the purpose of improving myocardial perfusion.

    Contraindications

    The AngioSculpt catheter should not be used for the following: Coronary artery lesions unsuitable for treatment by percutaneous revascularization. Coronary artery spasm in the absence of a significant stenosis.

    Warnings

    Administer appropriate antiplatelet, anticoagulant and coronary vasodilator therapy, consistent with institutional practice for coronary stent procedures, during and after the procedure. This device is intended for single (one) use only. Do not desterilize and/or reuse, as this can potentially result in compromised device performance and increased risk of inappropriate desterilization and cross contamination. For use in de novo or in-stent restenosis (ISR) lesions, the inflated diameter size of the balloon should approximate the vessel diameter size just proximal and distal to the stenosis, in order to reduce potential vessel damage. When used to pre-dilate the lesion prior to pre-planned stenting, the catheter should be one size smaller than the estimated vessel diameter (e.g., a 2.5 mm diameter device should be used in a vessel estimated to have a 3.0 mm diameter). PTCA in patients who are not acceptable candidates for coronary artery bypass graft surgery requires careful consideration, including possible hemodynamic support during PTCA, as treatment of this patient population carries special risk. When the catheter is exposed to the vascular system, it should be manipulated while under high-quality fluoroscopic observation. Do not advance or retract the catheter unless the balloon is fully deflated under vacuum. If resistance is met during manipulation, determine the cause of the resistance before proceeding. Do not exceed the rated burst pressure (RBP) during balloon inflation. The RBP is based on results of in-vitro testing. At least 99.9% of the balloons (with 95% confidence) will not burst at or below their RBP. Use of a pressure monitoring device is recommended to prevent over-pressurization. PTCA should only be performed at hospitals where emergency coronary artery bypass graft surgery can be quickly performed in the event of a potential cardiovascular injury or life-threatening complication. Use only the recommended balloon inflation medium. Never use air or any gaseous medium to inflate the balloon. Use the device prior to the expiration date specified on the package.

    Precautions

    Take extra care when using the Angio Sculpt catheter to treat a lesion distal to a freshly deployed stent. This precaution is particularly applicable to a drug-eluting stent so as to minimize the risk of damage to the stent coating. Prior to angioplasty, examine the catheter to verify functionality, catheter integrity and to ensure that its size and length are suitable for the specific procedure for which it is to be used. Only physicians trained in the performance of percutaneous transluminal coronary angioplasty should use the Angio Sculpt catheter. Do not rotate the catheter shaft in excess of 180 degrees when the tip is constrained. Do not rotate the catheter lure hub in excess of five (5) turns during use. Do not advance or retract the Angio Sculpt catheter over the floppy portion of the guidewire. Catheter manipulation, including advancement and retraction, should be performed by grasping the catheter shaft. If unusual resistance is felt when the catheter is being manipulated or if it is suspected that the guidewire has become kinked, carefully remove the entire catheter system (Angio Sculpt catheter and steerable guidewire) as a unit. If fluoroscopic guidance indicates that the Angio Sculpt catheter has advanced beyond the end of the guidewire, withdraw the catheter and reload the wire before advancing again.

    Possible adverse effects

    Possible adverse effects include, but are not limited to, the following: Death; Heart Attack (acute myocardial infarction); Total occlusion of the treated coronary 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 angina; Thromboembolism or retained device components; Irregular heart rhythm (arrhythmias, including life-threatening ventricular arrhythmias); Severe low (hypotension)/high (hypertension) blood pressure; Coronary artery spasm; Hemorrhage or hematoma; Need for blood transfusion; Surgical repair of 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); Infection.

    Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.

     

    References

    1. Davies JE, et al., DEFINE-FLAIR: A Multi- Centre, Prospective, International, Randomized, Blinded Comparison of Clinical Outcomes and Cost Efficiencies of iFR and FFR Decision-Making for Physiological Guided Coronary Revascularization. New England Journal of Medicine, epub March 18, 2017.
    2. Gotberg M, et al., iFR-SWEDEHEART Investigators. Instantaneous Wave-free Ratio versus Fractional Flow Reserve to Guide PCI. N Engl J Med. 2017 May 11;376(19):1813-1823.
    3. Patel M. “Cost-effectiveness of nstantaneous 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, 2018.4. A.
    4. Maehara, M. Matsumura, Z.A. Ali, G.S. Mintz, G.W. Stone. IVUS-guided versus OCT-guided coronary stent implantation. J Am Coll Cardiol Img, 10 (2017), pp. 1487- 1503.
    5. Choi K, et al. Impact of Intravascular Ultrasound-Guided Percutaneous Coronary Intervention on Long-Term Clinical Outcomes in Patients Undergoing Complex Procedures. JACC: Cardiovascular Interventions. Mar 2019, 4281; DOI: 10.1016/j.jcin.2019.01.227.
    6. Co-registration tools available within IntraSight 7 configuration via SyncVision.
    7. Zhang J et al. The ULTIMATE trial. Journal of the American College of Cardiology (2018), doi.org/10.1016/j.jacc.2018.09.013.
    8. Patel M, et al., ACC/AATS/AHA/ASE/ASNC/SCAI/SCCT/STS 2017 8. 2018 ESC/EACTS Guidelines on myocardial revascularization: The task force on myocardial revascularization of the European society of cardiology (ESC) and European association for cardio-thoracic surgery (EACTS). Eur Heart J. 2018;00:1-96.
    9. Lofti A, et al. Focused update of expert consensus statement: Use of invasive assessments of coronary physiology and structure: A position statement of the society of cardiac angiography and interventions. Catheter Cardiovasc Interv. 2018;1–12.
    10. Davies JE, et al., Use of the Instantaneous Wave-free Ratio or Fractional Flow Reserve in PCI. N Engl J Med. 2017 May 11;376(19):1824-1834.
    11. Comparisons to Verrata Plus. Data/report internally on file or internal company’s data on file. Verification Report, D000410086/A.
    12. Data shown is in average, based on the comparison between remotely connected and non-remotely connected systems. Data sample from 2018 for Allura FD and Azurion (n=9955)
    13. Results obtained during a Usability Evaluation in the period of May and June 2019. The tests involved 23 clinicians (16 physicians and 7 technologists) from Europe who performed procedures using Azurion 2.1 image-guided therapy system in a cardiac workflow and non-cardiac workflow in a simulated interventional lab environment.

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