The Texas Cardiac Arrhythmia Institute (TCAI) at St David's Medical Center has become the first clinic in the US to use Medtronic’s Affera mapping and ablation system with the Sphere-9 catheter since the device was approved by the US Food and Drug Administration (FDA) in October 2024.
The all-in-one high-density mapping and dual-energy ablation catheter allows physicians to deliver energy to a specific area of the heart and map a patient's heart at the same time for the treatment of heart arrhythmias, including persistent atrial fibrillation and atrial flutter, which research suggests may affect up to 200,000 people in the US annually.
Physicians can customise the device’s function to patient needs during an ablation procedure, with the option to use either a pulsed field ablation (PFA) or radiofrequency energy delivery to correct fast or abnormal heart rhythms.
PFA is a minimally invasive procedure that uses high-voltage electrical pulses to treat atrial fibrillation (AFib) and other cardiac arrhythmias.
Andrea Natale, cardiac electrophysiologist and executive medical director of TCAI, commented: "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.
“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."
According to GlobalData analysis, the electrophysiology (EP) ablation catheter segment of the cardiovascular devices market was valued at around $2.52bn in 2023 and is forecast to reach a valuation of around $3.86bn by 2033. Further GlobalData analysis indicates that the EP diagnostic catheter market will grow at a CAGR of 10% in market value from 2024 to 2033.
In April 2024, TCAI implemented a new PFA system for treating patients with paroxysmal and persistent atrial fibrillation.
In 2022, the medical centre announced surpassing the performance of 3,000 robotic cardiac ablation procedures, the majority of which treated ventricular tachycardia. The milestone represented the completion of the most robotic cardiac ablation procedures by any one facility in North America, as per the company’s press release.
Elsewhere in PFA, Boston Scientific resumed enrolment last month in a trial testing its Farapulse technology in patients with AFib previously paused to evaluate observations made in the study’s early stages.
