Medtronic today announced an expanded CE-mark indication for the Affera mapping and ablation system with Sphere-9 catheter to treat ventricular arrhythmias, including ventricular tachycardia (VT) and premature ventricular complexes (PVCs). The Sphere-9 catheter is the first all-in-one mapping and ablation, large-tip, focal, dual-energy catheter CE marked for ventricular ablation, according to Medtronic.
“This milestone is a major step forward as we continue to expand the footprint of the Affera technology to more physicians and patients,” said Rebecca Seidel, president of the electrophysiology therapies business at Medtronic. “Indication expansion to include ventricular arrhythmias unlocks another fast-growing market opportunity to keep building on our momentum, powered by the versatility, safety and efficiency of the Sphere-9 catheter.”
Additionally, in recognition of the critical unmet need for ventricular arrhythmia treatments, the US Food and Drug Administration (FDA) has granted Breakthrough Device designation for the Sphere-9 catheter for the treatment of ventricular arrhythmias, providing an expedited regulatory pathway for the technology in this patient population. The Sphere VT pivotal trial to evaluate Sphere-9 for the treatment of VT and support future approval in the USA is now enrolling patients too.
Medtronic describes the Affera mapping and ablation system with Sphere-9 catheter as an all-in-one, dual-energy pulsed field (PF) and radiofrequency (RF) ablation and high-definition mapping catheter for use in cardiac ablation procedures.
“Physicians have long needed better tools for ventricular arrhythmias, and we’re proud to deliver a technology that addresses this unmet need and moves the needle on patient care,” said Khaldoun Tarakji, vice president and chief medical officer of the cardiac ablation solutions business—which is part of the cardiovascular portfolio—at Medtronic. “The unique features of Sphere-9, including a single catheter to map and ablate using RF or PF energy, and a large footprint, make it an excellent tool for a variety of arrhythmias, including those that may be challenging to treat.”
