Medtronic’s Affera System: A Breakthrough in Electrophysiology with FDA Approval for All-in-One Pulsed Field Ablation

FDA Approval:
The U.S. Food and Drug Administration (FDA) has approved Medtronic's Affera mapping and ablation system with the Sphere-9 catheter for the treatment of persistent atrial fibrillation (AFib) and cavotricuspid isthmus-dependent atrial flutter.

All-in-One System:
The Affera system is an all-in-one electrophysiology offering capable of both pulsed field ablation (PFA) and radiofrequency (RF) ablation, providing more treatment options for operators.

Sphere-9 Catheter:
The Sphere-9 catheter features a 9 mm lattice tip designed for wide-area circumferential ablations, offering both PFA and RF energy capabilities.

Clinical Trial Data:
The FDA approval was based on data from the SPHERE PER-AF clinical trial, which showed that the Affera system was non-inferior to conventional treatment options for persistent AFib.

Market Impact:
The approval positions Medtronic as the first company to offer two FDA-approved PFA systems for AFib treatment, potentially impacting the market share of competitors like Boston Scientific and Johnson & Johnson.

Acquisition Background:
Medtronic acquired Affera in August 2022 for approximately $925 million, enhancing its capabilities in treating cardiac arrhythmias.

Market Competition:
Analysts predict that Affera could significantly impact point-by-point ablation procedures, traditionally dominated by Johnson & Johnson and Abbott, and potentially lead to price pressure and market share shifts.