Medtronic’s all-in-one mapping and ablation system gains expanded CE mark approval
Medtronic has secured an expanded CE mark approval for its Affera Mapping and Ablation System with Sphere-9 Catheter. The device can now be used to treat ventricular arrhythmias, including ventricular tachycardia (VT) and premature ventricular complexes.
The all-in-one system, which is capable of both pulsed field ablation (PFA) and radiofrequency (RF) ablation, previously secured CE mark approval for the treatment of persistent atrial fibrillation (AFib). Now it can target patients with AFib as well as those with ventricular arrhythmias.
“This milestone is a major step forward as we continue to expand the footprint of the Affera technology to more physicians and patients,” Rebecca Seidel, president of the electrophysiology therapies business at Medtronic, said in prepared remarks. “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.”
“The unique features of Sphere-9, including a single catheter to map and ablate using RF or pulsed field energy and a large footprint, make it an excellent tool for a variety of arrhythmias, including those that may be challenging to treat,” added Khaldoun Tarakji, MD, MPH, vice president and chief medical officer of cardiac ablation solutions for Medtronic.
Medtronic also on ‘fast track’ to an additional approval
While the Affera Mapping and Ablation System with Sphere-9 Catheter has already received U.S. Food and Drug Administration (FDA) approval for treating AFib, it has not yet been approved for ventricular arrhythmias. According to an additional update from Medtronic, however, that could soon change: The device has received the FDA’s fast-track designation for ventricular arrhythmias.
The designation is intended to help speed the approval process for companies developing treatments for life-threatening conditions, especially those that fill an unmet need. Fast-tracked therapies are eligible for more frequent meetings with the FDA, more written communication with the agency and accelerated approvals once certain criteria are met.
Patients are now being enrolled for a pivotal trial focused on the technology’s impact on patients with VT.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.