Medtronic's Novel All-in-One AFib Mapping and Ablation System Receives FDA Approval

Medtronic has obtainedReceived approval from the U.S. Food and Drug Administration (FDA) for its newThe Affera Mapping and Ablation System is equipped with the Sphere-9 catheter, an integrated electrophysiology product capable of performing both pulsed field ablation (PFA) and radiofrequency (RF) ablation. The system has been approved for the treatment of...Persistent Atrial Fibrillation (AFib) and tricuspid isthmus-dependent atrial flutter. It previously received CE Mark approval in March 2023.

Medtronic is now the first company to offer two FDA-approved PFA systems for the treatment of AFib. The company's PulseSelect PFA system was approved in January 2023.February receives FDA approval.

The core of the system, the Sphere-9 catheter, includes a 9 mm lattice tip designed to provide large-area circumferential ablation.It can deliver pulsed field or radiofrequency energy, a feature that gives operators more treatment options at their fingertips compared to other commercially available PFA products.

"The importance of this innovative technology should be emphasized;"Affera is a game-changer for treating AFib and atrial flutter."Vivek Reddy, MD, Director of the Cardiac Arrhythmia Service at Mount Sinai Health System in New York City and a renowned leader in the field of ablation technology, said in a statement. 'The Affera system provides physicians with a safe, effective, and efficient solution to address this common and increasingly serious heart condition, requiring optimized solutions for patients. The learning curve for experienced physicians is short, and the possibilities for treating AFib are limitless.'"

"At Medtronic, we have a 75-year tradition of being guided by our mission and commitment to bring disruptive innovations to market that meet unmet patient needs," added Rebeca Seidel, President of Medtronic's Cardiac Ablation Solutions business. "With the approval of Affera, we are excited to bring clinicians a novel mapping and ablation solution designed to make AFib treatment safer, more effective, and more efficient."

Affera System Associated with Positive Patient Data

The FDA's decision was primarily based on data from the SPHERE PER-AF clinical trial, which compared the Affera mapping and ablation system and Sphere-9 catheter for the treatment of persistent AFib with other commercially available treatment options. The study confirmed that when patients exhibited resistance to antiarrhythmic drugs for persistent AFib, the Affera and Sphere-9 technologies were not inferior to the "standard of conventional care."

Preliminary results of SPHERE PER-AF have been announced at the 2024 Annual Scientific Sessions of the Heart Rhythm Society held in Boston and simultaneously published inNature MedicineAbove. [1]

Medtronic Announces After Acquiring Affera for Approximately $925M in 2022

This announcement has been in the making for Medtronic for many years. The company acquired Affera in August 2022, a healthcare technology firm based in Massachusetts that focuses on treating arrhythmias. The deal was reported to be worth $925 million, though neither company disclosed the final figure. The two companies were already familiar with each other; prior to this deal, Medtronic owned 3% of Affera.

"This acquisition enhances and accelerates our ability to leverage innovative technologies to treat millions of patients with arrhythmias worldwide," said Doron Harlev, founder of Affera and current Vice President of Engineering for Cardiac Ablation Solutions, at the time. "Our team designed the Affera platform with the needs of both physicians and patients in mind, aiming to advance the field of electrophysiology while supporting safe and efficient cardiac ablation procedures."

Reference:

1. Elad Anter, Moussa Mansour, Devi G. Nair, et al. Dual-energy lattice-tip ablation system for persistent atrial fibrillation: a randomized trial. Nature Medicine. May 17, 2024.