The studies looked at the Affera family of technologies. Those include the next-generation Sphere-360 single-shot PFA catheter and the Sphere-9 combination mapping and dual-energy focal PFA catheter.
Investigators presented findings at the Heart Rhythm Society (HRS) 2025 Annual Meeting in San Diego. The data joined additional findings from Medtronic presented at HRS for its OmniaSecure defibrillation lead.
Medtronic has integrated this PFA technology with its Affera mapping and ablation system. The Affera technology makes up a key component of Medtronic’s PulseSelect PFA system. It became the first such system FDA-cleared for treating AFib late last year. Integration offers complete visualization inside the heart and electroanatomical mapping. Medtronic brought in these technologies through its $1 billion acquisition of Affera in August 2022.
The company also last year received the FDA’s green light to study the system in treating ventricular tachycardia (VT).
“True to our Medtronic mission for patients and legacy of innovation, we are delivering our best-in-class technologies to physicians and improving care for AFib patients, and we are not slowing down,” said Rebecca Seidel, president of the Cardiac Ablation Solutions business at Medtronic. “These results signify another step forward and energize us as we continue to earn and build our leadership position in electrophysiology every day.”
A look at the Sphere-360 system’s safety and performance
Sphere-360, an investigational single-shot mapping and ablation catheter, uses pulsed field energy to treat patients with paroxysmal AFib.
Medtronic designed Sphere-360 with the goal of simplifying the AFib procedure while enhancing efficiency and providing high lesion durability. Sphere-360 features a large, tissue-conformable lattice tip for energy delivery. It requires no catheter rotation multiple times in one location as the entire lattice tip delivers PF energy. The company says it features the smallest sheath (8.5 Fr) in any single-shot PFA technology.
Results at one year in a prospective, single-arm, multi-center trial demonstrated freedom from arrhythmia recurrence in 88% of patients.
The catheter delivered chronically durable pulmonary vein isolation (PVI) in 98% of targeted veins. Investigators reported zero safety events in a subgroup treated with the most optimized waveform.
Medtronic plans to begin a U.S. pivotal trial for Sphere-360 this year.
“The Affera technology is a sophisticated ecosystem, including an advanced, intuitive mapping system and catheters that are seamlessly integrated to offer treatment options for different cardiac arrhythmias. It is encouraging to see the promising results for Sphere-360, which can easily create circumferential lesions without the need for catheter rotation,” said Dr. Vivek Reddy, director of cardiac arrhythmia services for the Mount Sinai Health System in New York City. “The study results showed Sphere-360 has a promising safety and performance profile with zero serious adverse events observed. Upon approval, Sphere-360 will be a valuable addition to Medtronic’s Affera system, which has been a game changer for Afib treatment and physician workflow.”
Medtronic has data on Sphere-9 for linear ablation
Sphere-9 is a catheter system that uses a nitinol cage to deliver both radiofrequency (RF) and pulsed field energy for ablation.
The Sphere-9 focal catheter’s 9 mm lattice tip is smaller than the Sphere-360 single-shot PFA catheter, which has an expandable diameter of up to 34 mm. For PVI plus, cardiologists need a smaller catheter that can deliver more targeted, focal energy versus single-shot ablation (from the Sphere-360 or PulseSelect catheters) that delivers energy around the entirety of the pulmonary vein without the cardiologist having to rotate the catheter.
A sub-analysis from the Sphere Per-AF IDE study demonstrated that Sphere-9 can be used safely and effectively to create linear lesions in persistent AFib patients. Linear ablation often works in conjunction with PVI to improve the chances of restoring a normal heart rhythm without recurrence.
Sphere Per-AF evaluated the safety, efficacy and efficiency of Affera and Sphere-9 in persistent AFib. It led to the FDA approval of Affera in October 2024.
