Combining Imaging and Physiology into one ultra-low-profile catheter
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Latest Market Updates
Both IVUS and FFR are now Class 1a recommendations in Europe and the US
Zed Medical is developing a novel dual-mode catheter that combines physiology and ultrasound to offer optimal coronary interventional guidance with exceptional ease of use.
Eliminate the need to choose between FFR and IVUS
The only dual-mode FFR & IVUS tool to improve clinical decision making, workflow, and costs
Percuataneous Coronary Intervention (PCI) Tools
Angiogram
Procedural Guidance
Angiograms have been the standard of care in interventional cardiology for many years, but they have limitations. Since they provide only a two-dimensional image, they offer limited insight into vessel patency. Key details, such as tissue morphology and the presence of calcium, are not easily discernible. Additionally, angiograms do not clearly indicate the extent of blood flow restrictions
Defer or Intervene? Which lesion?
During diagnostic angiograms, physiology measurements help evaluate the severity of coronary artery lesions. By assessing pressure differences across a lesion, Fractional Flow Reserve (FFR) determines whether intervention is needed, guiding precise treatment decisions. This technology is crucial in enhancing the outcomes of coronary interventions by allowing physicians to focus on clinically significant lesions and avoid unnecessary or inappropriate procedures
Interventional Optimization
IVUS is an essential imaging technique used in percutaneous coronary interventions (PCI). It delivers real-time ultrasound images from inside the artery, offering critical information about vessel structure, plaque distribution, calcium changes, and the sizing, placement, and expansion of stents. This detailed imaging of soft tissues helps tailor procedures to achieve the best possible patient outcomes by providing an accurate understanding of coronary anatomy and lesion characteristics.
In the US, FFR is used in about 19% of interventions and IVUS in 23.5%, with fewer than 3% utilizing both due to cost, time, and complexity.
The Zed Platform
System Overview
Eliminate the need to choose between FFR and IVUS
Catheter
- Long rail ultra-low-profile catheter.
- Next generation 20/30MHz phased array IVUS.
- Integrated pressure sensing.
Console
- “Plug and play” always “on”.
- Bed rail interface/touch screen.
- Future ready AI/ML guidance
The Zed Medical platform is built on three groundbreaking proprietary components:
A world-first programmable, disposable ultrasound ASIC (Application-Specific Integrated Circuit).
A highly deliverable, patent-protected, ultra-low-profile catheter for acquiring both FFR and IVUS data.
An advanced bedside console that seamlessly controls and displays IVUS and FFR information while automatically capturing angiography images for AI/ML-based image fusion.
Global Market Landscape
The global market for FFR and IVUS technologies is poised for substantial growth.
Market Size
Total Addressable Market (2029)
These factors collectively promote the adoption of these technologies to enhance patient care.
The Opportunity for Zed Medical
Market Trends and Future Directions
Both IVUS and FFR are now Class 1a recommendations in Europe and the US
Read More
Economic Benefits
Using FFR and IVUS will streamline decision making and reduce time.
Centers for Medicare and Medicaid Services (CMS) increased cash amount (+$2,258) to the reimbursement for IVUS and FRR during diagnostic procedures *
ESC updated IVUS/OCT guidelines to 1A – August 2024.
ACC/AHA/SCAI updated guidelines on February 28th, 2025 for IVUS to be a Class 1A.
Physician eligible for both IVUS and FFR CPT reimbursements with single device.
Clinical Benefits
The proven reduction in MACE rates and mortality with FFR or IVUS will be further enhanced when both are routinely used together.
Advancements in Artificial Intelligence (AI) and Machine Learning (ML) are enhancing the interpretation of IVUS images, enabling clinicians to more effectively assess complex coronary lesions.
* CMS reimbursement +$2,258 for IVUS/FFR during Diagnostic Angiograms. There more than are three times as many Diagnostic Angiograms as PCI Interventions.