First U.S. cases using Medtronic Affera ablation system: Key points
A hospital in Texas made headlines today with the announcement that its electrophysiologists have successfully completed the first U.S. procedures using the Medtronic Affera platform, marking a significant milestone. Dr. Andrea Natale and Dr. Amin Al-Ahmad lead the team of EPs at the Texas Cardiac Arrhythmia Institute (TCAI) at St. David’s Medical Center, where the innovative Affera system was deployed for the first time in the U.S. on November 7th. Since then, additional hospitals have also begun utilizing the Affera system, as confirmed by a Medtronic spokesperson to MassDevice via email.
The FDA granted approval for Medtronic’s Affera mapping and ablation system featuring the Sphere-9 catheter on October 24th, marking a key moment for the company. With this approval, Medtronic became the first and only entity with two Pulsed Field Ablation (PFA) technologies available for treating atrial fibrillation (AFib). Additionally, the medtech giant also received approval from the FDA to conduct a study on using the Affera system for treating ventricular tachycardia (VT).
Medtronic’s Sphere-9 focal catheter is a pivotal component of the Affera system, offering healthcare providers the flexibility of delivering both pulsed field (PF) and radio frequency (RF) energy. The catheter seamlessly integrates with the Affera mapping and ablation system to provide a comprehensive solution for physicians. The user-friendly design not only enhances workflow efficiency but also ensures excellent safety and efficacy outcomes.
Dr. Natale highlighted the significance of this catheter, emphasizing its role as an all-in-one solution that streamlines the mapping, ablation, and validation processes without the need for multiple catheters. This streamlined process offers enhanced flexibility and efficiency to physicians, ultimately ensuring greater safety and efficacy outcomes for patients.
The Texas Cardiac Arrhythmia Institute is at the forefront of this cutting-edge innovation, paving the way for improved treatment options not only for patients in Central Texas but also beyond. With continued advancements in global innovation for treating heart arrhythmias, the institute remains committed to leading the charge towards better care and outcomes for patients worldwide.
