Philips OmniWire
Pressure guide wire
A new wire from tip to tail
iFR is the only clinically-proven resting index2,3
iFR - A marker for assessing resting state based on large-scale evidence.
The DEFINE FLAIR and iFR Swedeheart studies, involving over 4,500 cases from large-scale clinical data, demonstrated that iFR is non-inferior to FFR for predicting 1-year outcomes. This was proven in two studies.2,3
A bar chart illustrates the results of the DEFINE FLAIR and iFR Swedeheart studies, comparing patient groups (DEFER, FAME, FAME 2, iFR Swedeheart, DEFINE FLAIR) with corresponding patient counts (n=325, n=509, n=1,220, n=2,037, n=2,492).
iFR cutoff value based on large-scale clinical data: 0.892,3
Two large-scale clinical studies demonstrated that an iFR cutoff value of 0.89 predicts favorable outcomes, establishing iFR as a standalone assessment tool.2,3
A horizontal slider visualizes the iFR range from 0.60 to 1.00, with key points marked: 'Treat' around 0.70 and 'Defer' at 0.89, indicating the cutoff value.
Guideline Recommendations for iFR
The 2018 Japanese Circulation Society Guidelines for the Diagnosis and Treatment of Chronic Coronary Artery Disease recommend iFR with Class IA for identifying coronary artery stenosis causing myocardial ischemia and for guiding PCI decisions, alongside FFR.4
The 2018 Japanese Circulation Society Guidelines for Revascularization in Stable Coronary Artery Disease recommend iFR with Class IA for cases of moderate stenosis where ischemia is not proven by non-invasive tests, and PCI is being considered for lesions other than the main culprit lesion.5
The 2018 European Society of Cardiology (ESC) Guidelines recommend using FFR or iFR (iwFR) to assess the hemodynamic significance of moderate stenoses when evidence of ischemia is not obtained, assigning Class IA.6
The document features an "iFR Class IA" logo.
From hypotube to large diameter solid core
Large diameter solid core structure
Traditional pressure wires use a hollow hypotube to protect the inner conductor or optical fiber. This necessitates a smaller, off-center core. OmniWire deviates from the hypotube structure, adopting a large, solid core design similar to conventional guidewires, eliminating internal gaps.2
Wire Cross-sections:
- Traditional pressure wire cross-section: Depicts a hollow hypotube containing a conductor, with a small core positioned off-center.
- OmniWire proximal cross-section: Shows a large, solid core with no internal gaps, surrounded by a polymer layer.
- General guidewire proximal cross-section: Similar to OmniWire, it shows a large, solid core without internal gaps, enclosed by a polymer layer.
Impact on wire performance and durability
Increasing the core diameter generally enhances torque performance and pushability. A solid structure, free of internal gaps, is expected to improve kink resistance and durability.2
Performance Attributes:
- Torque performance [arrow symbol]
- Pushability [arrow symbol]
- Kink resistance [arrow symbol]
- Durability [arrow symbol]
Note: These are conceptual diagrams and do not represent exact scale.
Workhorse design changes everything
Product Concept
OmniWire draws inspiration from the structure of general guidewires, leading to the development of its large diameter solid core design. It incorporates various materials and structures optimized for the handling and electrical stability of pressure wires, aiming to facilitate efficient procedures.
OmniWire Components:
- Protective sensor housing: Reduces sensor exposure and enhances protection, with automated manufacturing.
- Stainless steel shaping ribbon: Made of stainless steel for easier shaping. Tip load is 0.53g (internal testing).
- Distal core: Nitinol: Features Nitinol (nickel-titanium alloy) for high shape memory.
- Proximal core: Cobalt alloy: Enhances pushability due to the large diameter solid core.
- Integrated conductive band: Achieves integrated conductivity by eliminating multi-part assembly, using conductive ink.
- All-plastic torque device: Developed based on physician feedback to protect the OmniWire.
- Push-on connector: Ergonomically designed for easy wire attachment and detachment.
OmniWire will bring you to a new physiology stage
Advancing Physiology with New Systems
OmniWire is compatible with the new console systems, IntraSight and SyncVision. IntraSight enhances workflow efficiency, while SyncVision supports PCI strategy by mapping pressure gradients onto angiographic images.
System Integration Examples:
- IntraSight system display showing a pullback curve with iFR values, indicating a distal iFR of 0.80 and an estimated iFR of 0.96.
- SyncVision system display overlaying pressure gradient mapping onto an angiographic image, with lesion length measurement and estimated post-treatment values.
Product Information
Catalog Number: 89185
Product Name: OmniWire Pressure Guidewire
FPC Adapter
Remarks: Length: 185cm, Tip Shape: Straight. Core and s5 series require the Pimmette adapter. Direct connection is possible with the IntraSight imaging system, eliminating the need for an adapter.
Product Specifications
A diagram illustrates the OmniWire's structure, showing the distal end with a pressure sensor, hydrophobic coating, and radiopaque section, and the proximal end featuring a conductive band, torque device, and connector.
- Distal end components: Pressure sensor, hydrophobic coating, radiopaque section.
- Proximal end components: Conductive band, torque device, connector.
- Measurements: 3 cm Flexible length, 40 cm Hydrophobic coating, 185 cm Overall length.
For details, please refer to the medical device instructions for use.
Website: www.philips.com/OmniWire
References
1. Data on File.
2. 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.
3. 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.
4. Japanese Circulation Society et al.: Guidelines for the Diagnosis and Treatment of Chronic Coronary Artery Disease (2018 Revision) http://www.j-circ.or.jp/guideline/pdf/JCS2018_yamagishi_tamaki.pdf (Accessed April 2019)
5. Japanese Circulation Society et al.: Guidelines for Revascularization in Stable Coronary Artery Disease (2018 Revision) http://www.j-circ.or.jp/guideline/pdf/JCS2018_nakamura_yaku.pdf (Accessed April 2019)
6. 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.
Manufacturer and Distributor
Manufacturer/Distributor: Philips Japan, Ltd.
Address: 2-13-37 Konan, Minato-ku, Tokyo 108-8507, Philips Building
Customer Service: 0120-556-494 / 03-3740-3213
Hours: 9:00 AM - 8:00 PM (Closed on weekends, public holidays, and year-end/New Year holidays)
Website: www.philips.co.jp/healthcare
Specifications are subject to change without notice for improvement. Please consult your sales representative or Customer Service for details. Product names and other proper nouns are trademarks or registered trademarks of Koninklijke Philips N.V. or other companies.
© 2020 Philips Japan, Ltd.
Product Registration:
- OmniWire Pressure Guidewire, Medical Device Approval Number: 30200BZX00112000
- SyncVision System, Medical Device Certification Number: 230ACBZX00008000
- IntraSight Imaging System, Medical Device Certification Number: 301AFBZX00033000
