The all-in-one, high-density (HD) mapping, pulsed field ablation (PFA) and radiofrequency (RF) ablation system treats persistent atrial fibrillation (AFib) and offers RF ablation for cavotricuspid isthmus (CTI) dependent atrial flutter. Medtronic also recently received the FDA’s green light to study the system in treating ventricular tachycardia (VT).
Medical Design & Outsourcing: Medtronic’s Affera Sphere-9 catheter uses nitinol in a new way
Medtronic said the approval makes it the first and only company with two PFA technologies available for treating AFib. The medtech giant also makes the PulseSelect PFA system, which this year became the first PFA system win FDA approval. PulseSelect delivers single-shot cardiac ablation for pulmonary vein isolation (PVI), while the Sphere-9 catheter enables flexibility with a wide area focal design and 9mm lattice tip that works with an 8.5Fr sheath.
The Sphere-9 focal catheter offers physicians the option of both PF and RF energy delivery, fully integrated with the Affera mapping and ablation system. Medtronic said it enhances workflow efficiency for physicians while providing excellent safety and efficacy outcomes.
“At Medtronic, we have a 75-year tradition of bringing disruptive innovation to market, guided by our mission and commitment to address the unmet needs of patients. With the approval of Affera, we are excited to bring a novel mapping and ablation solution to clinicians that is intended to make atrial fibrillation treatment safer, more effective, and more efficient,” said Rebecca Seidel, president of the Cardiac Ablation Solutions business, which is part of the Medtronic Cardiovascular Portfolio. “The potential of Affera is limitless. We will continue to fulfill our commitment to innovation, including new indications, to advance cardiovascular care and improve patient outcomes.”
Related: How Medtronic designed the PulseSelect pulsed field ablation system for AFib
More about how Medtronic earned approval for the Affera system
Medtronic brought in these technologies through its $1 billion acquisition of Affera in August 2022. The ablation space remains hot, with Boston Scientific and Johnson & Johnson MedTech, among others, developing ablation tech. Boston Scientific became the second company to win FDA approval for PFA, following Medtronic with its Farapulse system in January.
Medical Design & Outsourcing: Pulsed field ablation catheters take shape at Medtronic, Boston Scientific, Abbott and J&J’.
Affera received CE mark in 2023. In January, Medtronic CEO Geoff Martha reported “good progress” in bringing the Affera Sphere-9 PFA mapping and ablation catheter to the U.S. market this year. Medtronic filed for FDA approval for the system in the U.S. earlier in 2024 and had positive data for Affera in May.
Medtronic said approval came on the back of results from the pivotal SPHERE Per-AF study, an FDA IDE trial. It compared Sphere-9 with Affera to the J&J Thermocool SmartTouch SF RF ablation catheter with Carto 3 mapping.
“The Affera system was designed to address procedural challenges faced by the electrophysiology community while maintaining a high standard of safety and efficacy for patients. By enabling a single transeptal, zero-fluoroscopy, and zero-exchange workflow, the Sphere-9 catheter uniquely integrates both mapping and ablation technologies, offering the flexibility to use either pulsed field or radiofrequency energy,” said Affera founder Doron Harlev, who’s now VP of engineering for Cardiac Ablation Solutions at Medtronic. “This marks an exciting milestone for the field, with Medtronic’s robust innovation pipeline poised to drive continued progress.”
First look: Medtronic’s Affera Sphere-360 pulsed field ablation catheter design has some new tricks.
The analysts’ take
BTIG analysts Marie Thibault and Sam Eiber said approval fell largely in line with their timing expectations. They say Medtronic filed for approval in May or even a bit earlier, meaning approval took less than six months. With that in mind, after J&J submitted Varipulse to the FDA in March, they expect that approval to come soon, too.
“We think that all four PFA platforms show excellent safety and efficacy profiles that are comparable to traditional thermal energy systems and enable faster procedure times,” the analysts wrote. “We remain bullish on PFA and continue to expect rapid commercial uptake in the U.S. as devices launch and new systems are approved.”
