The Pipeline

Despite FDA clearance, FIRM ablation’s impact still unknown

Haley David and Rory Lubner, Technology Insights

Earlier this month, Topera Medical announced FDA 510(k) clearance of its FIRMap catheter, a diagnostic mapping catheter that helps target the source of a patient’s arrhythmia. This catheter, in combination with the company’s FDA-cleared RhythmView 3D Mapping Workstation, represents an innovative service for highly progressive electrophysiology (EP) programs across the country.

The diagnostic basket catheter and mapping system are key components of a progressive EP procedure known as FIRM ablation. During the procedure, the mapping catheter and system allow electrophysiologists (EPs) to view specific areas in the heart—or “rotors”—which may cause an arrhythmia to occur. FIRM ablation strives to pinpoint these underlying mechanisms sustaining complex arrhythmias, most notably atrial fibrillation (AF). 

Reducing procedure times, re-ablation rates the key to success

Currently, AF ablation is a challenging opportunity given its significant barriers to entry, lengthy procedure times, and frequent re-ablation rates. While a host of different technologies in development aim to treat this complex—and costly—AF patient population more effectively, several disease management gaps still exist.

FIRM ablation looks to fill these treatment gaps through two potentially game-changing considerations:

  1. Decreasing procedure times: Current ablation techniques require full pulmonary vein isolation (PVI), which requires a highly skilled EP and takes anywhere from two to six hours. By identifying the specific sources of arrhythmia, FIRM ablation may mitigate the need for full PVI and therefore significantly decrease ablation procedure times.

  2. Reducing re-ablation rates: Today’s ablation techniques likewise remain plagued by high arrhythmia recurrence rates, many of which result in hospital readmissions and additional ablation procedures. By targeting these arrhythmia “rotors,” FIRM improves an EP’s ability to ablate the arrhythmia’s source. It may therefore improve procedure outcomes and reduce re-ablation rates.

Ultimately, FIRM’s impact is still unknown, and adoption has been slow. While it represents an exciting innovation, FIRM remains reserved for highly progressive, specialized EP programs. Should the technology eliminate the need for PVI in the future, it could potentially replace the traditional mapping systems and ablation techniques in today’s EP labs.

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