EPs at the Texas Cardiac Arrhythmia Institute (TCAI) at St. David’s Medical Center performed the procedures with Affera. Dr. Andrea Natale and Dr. Amin Al-Ahmad conducted the first procedure on Nov. 7. A Medtronic spokesperson told MassDevice via email that additional hospitals have begun their use of Affera in the weeks since.
Medtronic received FDA approval for its Affera mapping and ablation system with the Sphere-9 catheter on Oct. 24. The approval made the company the first and only company with two PFA technologies available for treating AFib. The medtech giant also makes the PulseSelect PFA system, which last year became the first PFA system to win FDA approval.
The medtech giant also recently received the FDA’s green light to study the system in treating ventricular tachycardia (VT). In its second-quarter earnings report last month, the company said it’s ramping commercial availability for Affera as well.
Sphere-9, Medtronic’s focal catheter, offers physicians the option of both PF and RF energy delivery. It fully integrates with the Affera mapping and ablation system. Medtronic said it enhances workflow efficiency for physicians while providing excellent safety and efficacy outcomes.
“This all-in-one, first-of-its-kind catheter allows physicians to map, ablate and validate all with a single catheter, enhancing workflow flexibility and efficiency, ultimately enabling greater safety and efficacy,” Natale said. “As global innovation for the treatment of heart arrhythmias continues to advance, the Texas Cardiac Arrhythmia Institute is grateful to be leading the way for patients in Central Texas and beyond.”
