Today, a Texas hospital revealed its team of electrophysiologists successfully completed the inaugural procedures in the United States using the Affera platform by Medtronic (NYSE:MDT). Staff at the Texas Cardiac Arrhythmia Institute (TCAI) located at St. David’s Medical Center utilized the system. Dr. Andrea Natale and Dr. Amin Al-Ahmad spearheaded the initial procedure on November 7th. A representative from Medtronic informed MassDevice via email that other medical facilities have also initiated the use of Affera in recent weeks.
Following its FDA authorization on October 24th, Medtronic’s Affera mapping and ablation system featuring the Sphere-9 catheter is now available. This approval marks Medtronic as the sole provider offering two PFA technologies for treating AFib. The company also produces the PulseSelect PFA system, the first PFA to secure FDA approval last year.
Additionally, Medtronic has lately been granted permission from the FDA to explore the system’s capabilities in addressing ventricular tachycardia (VT). In their second-quarter earnings presentation the previous month, the company announced an increase in commercial distribution for Affera.
The Sphere-9, an integral catheter from Medtronic, enables doctors to choose between PF and RF energy options, seamlessly working with the Affera mapping and ablation system. Medtronic highlights its ability to boost workflow and ensure reliable safety and effectiveness outcomes.
“This groundbreaking, integrated catheter empowers doctors to map, ablate, and validate using a single catheter, streamlining flexibility and efficiency, which ultimately enhances safety and efficacy,” Natale commented. “With continuous global advancements in arrhythmia treatments, the Texas Cardiac Arrhythmia Institute is proud to pave the way for patients in Central Texas and beyond.”