01/ The Unmet Need02/ Why EGF Matters03/ The OptiMap™ System04/ Seamless Workflow Integration05/ Indications for Use06/ References
The OptiMap Solution

The OptiMap Solution

See What Matters
Cortex aims to improve AF ablation outcomes with Electrographic FlowTM Mapping, helping physicians See What Matters and leading to a focused ablation strategy with the least amount of ablative tissue destruction.
01/

The Unmet Need

Current AF Classifications do not reflect pathophysiology

Understanding the pathophysiology of AF is critical for effective treatment

AF pathophysiology is complex resulting in heterogenous clinical disease

One-size-fits-all and anatomic approaches have failed due to disease heterogeneity

Key to improving AF ablation outcomes is to treat the underlying AF disease pathophysiology

02/

Why EGF Matters

While pulmonary vein isolation (PVI) appears sufficient to treat some patients with persistent AF, a pressing need exists for technologies that can identify AF sources in patients who present for redo procedures with all pulmonary veins already isolated—an increasingly encountered clinical situation.

Electrographic Flow™ (EGF) mapping with the OptiMap™ System enables the full spatiotemporal reconstruction of atrial electrical wavefront propagation to identify active AF sources1 and estimates the consistency of observed wavefront patterns. Details of the pre-processing steps and algorithms have been published.2

EGF sources appear clinically relevant and their presence post-ablation correlates with high rates of AF recurrence.3,4

EGF mapping can detect these extra-PV sources of AF by organizing the chaotic endocardial electrograms to show the time-dependent activity of these drivers/triggers in the right and left atria, representing anatomically feasible targets for ablation.5

In a prospective, single-center study of 70 consecutive patients with persistent AF, EGF-guided ablation offers a more targeted and patient-specific ablation strategy beyond PVI: PVI + EGF-guided ablation resulted in lower AF recurrence rates (25.6%) compared with PVI-only (62.5%) or PVI + LINES (53.3%)[p=0.02].6

In the FLOW-AF randomized controlled trial of 85 patients with persistent or long-standing persistent AF, ablating EGF sources improved one-year freedom from AF by 51% on an absolute basis.7

03/

The OptiMap™ System

First and only 510(k) cleared AF mapping system with randomized controlled trial results demonstrating a statistically significant improvement in freedom from AF at 12 months post-ablation among patients treated with PVI + EGF-guided ablation v. PVI-only.7

EGF algorithms to detect the presence of functional mechanisms of AF enable stratification into distinct EGF phenotypes that may be useful in predicting procedural outcomes, and perhaps in predicting ablation strategy.7

As shown in the FLOW-AF study, EGF mapping is safe and effective for the evaluation and treatment of patients with non-paroxysmal AF.7

Current studies are limited by small number of non-randomized patients and technical limitations related to the use of the FIRMap basket mapping catheter. Larger studies are warranted to assess the results in a greater number of patients and assess if EGF-based ablation improves freedom fromAF/AT/AFL.

04/

Seamless Workflow Integration

The OptiMap™ System can be used with any commercially available 3-dimensional electroanatomic mapping/navigation system and can be used with any commercially available ablation catheters following their approved indications for use.

05/

Indications for Use

OptiMap™ System

The OptiMap™ System is used to analyze electrogram (EGM) signals and display results in a visual format for evaluation by a physician in order to assist in the diagnosis of complex cardiac arrhythmias.

The OptiMap™ Catheter

For use in cardiac electrophysiology procedures to assist in the diagnosis of arrhythmias that may be difficult to identify using conventional mapping systems alone (i.e., linear mapping catheters). The OptiMap™ Catheter may also be used for delivery of externally generated pacing stimuli.

06/

References

  1. Bellmann B, Lin T, Ruppersberg P, Zettwitz M, Guttmann S, Tscholl V, Nagel P, Roser M, Landmesser U, Rillig A. Identification of active atrial fibrillation sources and their discrimination from passive rotors using electrographic flow mapping. Clin Res Cardiol 2018;107(11):1021-1032.
  2. Haines DE, Kong MH, Ruppersberg P, Haeusser P, Avitall B, Szili-Torok T, Verma A. Electrographic flow mapping for atrial fibrillation: theoretical basis and preliminary observations. Journal of Interventional Cardiac Electrophysiology 2023;66(4):1015-1028.
  3. Szili-Torok T, Kis Z, Bhagwandien R, Wijchers S, Yap SC, Hoogendijk M, Dumas N, Haeusser P, Geczy T, Kong MH, Ruppersberg P. Functional electrographic flow patterns in patients with persistent AF predict outcome of catheter ablation.  J Cardiovasc Electrophsiol 2021;32(8):2148-58.
  4. Spitzer SG, Langbein A, Kong MH, Ruppersberg P, Rillig A, Szili-Torok T. Dependency of outcome on electrographic flow mapping parameters.  Heart Rhythm 2021;18(8):S225-6.
  5. Haines DE, Kong MH, Ruppersberg P, Spitzer SG, Noelker G, Rillig A, Szili-Torok T. Analysis of behavior of atrial fibrillation sources with electrographic flow mapping.  Heart Rhythm 2021;18(9):1626-7.
  6. Gagyi R, Bhagwandien R, Yap SC, Hoogendijk M, Wijchers S, Szili-Torok T. Electrographic flow mapping guided catheter ablation offers advantages for patients with persistent atrial fibrillation. Pacing Clinical Electrophysiol 2023;1-11.
  7. Reddy VY,  Langbein A, Petru J, Szili-Torok T, Funasako M, Dinshaw L, Wijchers S, Rillig A, Spitzer SG, Bhagwandien R, Metzner A, Kong MH, Neuzil P. A Randomized Trial of Electrographic Flow-Guided Redo Ablation for Nonparoxysmal Atrial Fibrillation (FLOW-AF). Accepted for publication in JACC EP 2024.