FDA Approves Medtronic's Affera System for Atrial Fibrillation Ablation
Key Insights
The FDA has approved Medtronic's Affera system (search), an all-in-one mapping and ablation solution, for treating atrial fibrillation (search) (AFib (search)).
The approval was based on the SPHERE PER-AF trial, which demonstrated the Affera system (search)'s non-inferiority to standard care in persistent AFib (search) patients.
Medtronic acquired Affera (search) in 2022 for approximately $925 million, integrating the innovative technology into its cardiac ablation solutions.
Medtronic has received FDA approval for its Affera system (search), a novel all-in-one mapping and ablation solution designed for the treatment of atrial fibrillation (search) (AFib (search)). This approval marks a significant advancement in cardiac electrophysiology, offering a new approach to improve the safety and efficacy of AFib ablation procedures.
The approval was primarily based on data from the SPHERE PER-AF clinical trial (NCT05120193), a study that compared the Affera system (search) and Sphere-9 catheter to conventional treatment options in patients with persistent AFib (search) resistant to anti-arrhythmic drugs. The results, presented at the Heart Rhythm Society 2024 annual meeting and published in Nature Medicine, demonstrated that the Affera system was non-inferior to the standard of care in this patient population.
SPHERE PER-AF Trial Details
The SPHERE PER-AF trial enrolled patients with persistent AFib (search) who had not responded to anti-arrhythmic medications. The study evaluated the Affera system (search)'s ability to map and ablate the areas of the heart responsible for the arrhythmia, using the Sphere-9 catheter. The primary endpoint was a composite of freedom from atrial fibrillation (search), atrial flutter, or atrial tachycardia at one year, without the use of antiarrhythmic drugs. The trial also assessed safety outcomes, including major adverse events related to the procedure.
Devi G. Nair, MD, a cardiologist with St. Bernards Healthcare and co-author of SPHERE PER-AF, highlighted the potential benefits of the Affera system (search) in a video interview with Cardiovascular Business, emphasizing its positive safety profile and potential for faster procedures.
Medtronic's Acquisition of Affera
Medtronic's acquisition of Affera (search) in August 2022 for approximately $925 million underscores the company's commitment to innovation in cardiac rhythm management. "At Medtronic, we have a 75-year tradition of bringing disruptive innovation to market, guided by our mission and commitment to address the unmet needs of patients," said Rebeca Seidel, president of Medtronic’s cardiac ablation solutions business. Doron Harlev, Affera’s founder and Medtronic’s current vice president of engineering for cardiac ablation solutions, stated that the Affera platform was designed with physicians and patients in mind, to advance the field of electrophysiology while supporting safe and efficient cardiac ablation procedures.
Clinical Implications
The Affera system (search) represents a significant advancement in the treatment of atrial fibrillation (search), a condition affecting millions worldwide. By providing an all-in-one solution for mapping and ablation, the Affera system has the potential to streamline procedures, improve outcomes, and reduce the burden of AFib (search) on patients and healthcare systems. The system's approval offers a new option for patients with persistent AFib who have not responded to conventional treatments.