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Clinical and regulatory considerations for novel electrophysiology mapping systems: Lessons from FIRM
Author(s) -
Wann Daniel,
Waks Jonathan W.,
Kramer Daniel B.
Publication year - 2018
Publication title -
pacing and clinical electrophysiology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.686
H-Index - 101
eISSN - 1540-8159
pISSN - 0147-8389
DOI - 10.1111/pace.13509
Subject(s) - medicine , transformational leadership , catheter ablation , atrial fibrillation , clinical practice , medical physics , intensive care medicine , cardiology , public relations , family medicine , political science
Atrial fibrillation (AF) presents a growing clinical and public health burden for which better rhythm control therapies are needed. Focal impulse and rotor mapping (FIRM), currently marketed as a part of the Topera Rotor Mapping system (Abbott Laboratories, Austin, TX, USA), represents a potentially transformational approach to guide the invasive treatment of AF. However, many years after its initial marketing clearance, the clinical utility of this technology remains uncertain. In this article, we review the scientific rationale for this novel approach to AF ablation, evaluate the current clinical evidence for FIRM‐guided ablation, and characterize its premarket regulatory assessment. Lessons for clinicians considering adoption of newly marketed mapping systems are presented.