The CathWorks FFRangio™ System quickly and precisely delivers the objective FFR guidance needed to optimize PCI therapy decisions for every patient.
Current PCI
Challenges
30% of patients indicated for stents by estimated visual assessment do not need to be treated with stents when evaluated with Fractional Flow Reserve1.
Estimated Visual Assessment
Intraprocedural PCI (percutaneous coronary intervention) decisions using conventional coronary angiography are still principally made via an estimated visual assessment today.
Advancing PCI Guidance and Decision-Making
The FAME study1 showed that coronary stent usage could be reduced by about one-third if PCI decisions are based on FFR (Fractional Flow Reserve) measurements instead of on angiography alone (2.7 vs. 1.9, P<0.001). The FAME study went on to show that these patients do better and have less complications.
Conventional FFR Issues
FFR provides objective data that is clearly beneficial in PCI decision-making. However, conventional wire-delivered FFR is still used in fewer than 20% of procedures because it requires an additional intervention, is associated with increased clinical risks, additional radiation exposure, and increased procedural costs.
THE SOLUTION
The CathWorks FFRangio™ Solution
CathWorks FFRangio System is the non-invasive FFR platform that quickly and precisely delivers objective multi-vessel physiologic measurements to cost-effectively optimize and confirm intraprocedural PCI therapy decisions.
- Improve PCI decision-making
Intraprocedural FFR improves PCI decision-making and outcomes for patients with multi-vessel coronary artery disease (CAD).The FAME trial1 randomized 1,005 patients to FFR-guided angiography with a ≤.80 FFR cutoff point vs. estimated visual assessment (angiography) alone as a basis to determine treatment (PCI or no PCI). Highlights include:
- 30% of patients indicated for stents with estimated visual assessment did not need to receive stents when evaluated with FFR.
- The number of stents used was greater by about one-third when the PCI decision was based on angiography alone versus FFR (2.7 vs. 1.9, P<0.001).
- One-year MACE (Major Adverse Cardiac Event) was higher in the visual angiography assessment arm compared to the FFR assessment arm (18.3% vs. 13.2%, P<0.02).
- Average cost-per-procedure for patients evaluated with FFR was reduced by 11.2% compared to angiography-only.
- Reduce risks and costs associated with estimated visual estimate
System reduces PCI-decision risks and costs associated with estimated visual assessment.- Reduces the risk of untreated asymptomatic blockage that is undetectable via estimated visual estimate.
- Reduces the procedural risks associated with unnecessary stent placement.
- Reduces the use of Heparin associated with unnecessary PCI procedures.
- Reduces overall cost of care associated with unnecessary coronary interventions.
- Make FFR practical for every case
CathWorks FFRangio System makes FFR-guided PCI decision-making practical for every case.- Delivers intraprocedural imaging, computation, and 3D multi-vessel modeling to quantify stenosis, optimize PCI decisions, and confirm end-of-case revascularization.
- CathWorks FFRangio provides objective FFR measurement without the risks associated with invasive FFR wires including additional interventions and pharmacologic administration.
- Uses existing cath lab imaging and angiography equipment – compatible with all major angiography systems.
- Introduces no additional SKUs or device-related procedure costs.
- Eliminates direct and indirect FFR wire costs.
1. No additional intervention required to obtain objective FFRangio measurement.
2. No direct or indirect wire or additional drug costs to perform FFRangio.
3. No need for vasodilator (Adenosine) administration.
4. No additional radiographic images needed with FFRangio.
5. No additional interventions (wire) required to perform FFRangio. - Confirm revascularization intraprocedurally
CathWorks FFRangio System enables objective intraprocedural confirmation of revascularization.- Makes objective and fast post-PCI physiological measurement a routine part of coronary angiography.
- Enables physicians to confirm revascularization and procedure efficacy across the entire coronary tree.
HOW IT WORKS
CathWorks System Technology
The CathWorks System works in combination with the angiography system in your cath lab to provide objective, non-invasive FFR data for PCI decision-making.
Intraprocedural
The CathWorks FFRangio System provides objective FFR data for PCI decision-making during the angiography procedure.
Connects
The CathWorks System connects directly to the angiography system in your Cath Lab and objective intraprocedural data is displayed on the FFR 3D Dashboard.
Compatible
The CathWorks System platform is compatible with most angiography systems including the four leading systems in the market today.
Digitizes
The CathWorks FFRangio System digitizes and computes angiography images to provide objective data for PCI decision-making.
Multi-vessel
The CathWorks System provides multi-vessel data so you can evaluate the entire coronary tree in one color-coded 3D image.
Confirms
The CathWorks FFRangio System enables you to confirm revascularization and procedural efficacy post-PCI.
REGULATORY STATUS
- United States FDA: CathWorks FFRangio received US FDA 510(K) clearance in December 2018.
- European Union / CE: CathWorks FFRangio has a CE Mark.
- Japan PMDA: CathWorks has a pending PMDA submission from early 2019.
- Israel: CathWorks FFRangio has Amar approval.
1. Tonino PAL, et al. Fractional Flow Reserve versus Angiography for Guiding Percutaneous Coronary Intervention. N Engl J Med. January 15, 2009; 360:213-224.