The expanded indication, announced today, includes ventricular tachycardia (VT) and premature ventricular complexes (PVCs). According to Medtronic, the Sphere-9 catheter is the first all-in-one mapping and ablation, large-tip focal, dual-energy catheter that is CE marked for ventricular ablation.
On top of the expanded indication news out of the European Union, Medtronic reported that the FDA has granted Breakthrough Device Designation for the Sphere-9 catheter for the treatment of ventricular arrhythmias; the Sphere VT pivotal trial to support future approval in the U.S. is now enrolling patients.
The expanded CE mark indication and FDA Breakthrough Device Designation should further boost Medtronic against competitors including Boston Scientific and Johnson & Johnson MedTech. The medtech giant’s cardiac ablation business has been a standout performer, enabling the company to post its best revenue growth in 10 years in the fourth quarter. (Medtronic acquired much of the tech through its $1 billion acquisition of Affera in August 2022.)
“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 a news release. “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.”
Used in cardiac ablation procedures, the Affera mapping and ablation system with Sphere-9 catheter is an all-in-one, dual-energy pulsed field (PF) and radiofrequency (RF) ablation and high-definition mapping catheter.
“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 Dr. Khaldoun Tarakji, VP and chief medical officer of Medtronic’s Cardiac Ablation Solutions business. “The unique features of Sphere-9, including a single catheter to map and ablate using radiofrequency 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.”
