Dive Brief:
- Medtronic has received a CE mark for its Affera Sphere-360 pulsed field ablation catheter in paroxysmal atrial fibrillation, the company said Friday.
- The single-shot device is designed to ablate target tissue without being rotated in each location, setting it apart from Boston Scientific’s Farawave catheter.
- Medtronic reported a more than 300% increase in PFA sales in its second quarter. The company has begun a clinical trial to support authorization of Sphere-360 in the U.S.
Dive Insight:
Medtronic’s portfolio of PFA catheters already includes Sphere-9 and PulseSelect. Sphere-9 improved on PulseSelect, Medtronic’s first PFA catheter, by combining mapping and delivery of radiofrequency energy and PFA in a single device.
However, as a focal catheter, Sphere-9 had different use cases from the single-shot PulseSelect. Focal ablation requires point-by-point energy delivery, while single-shot devices have a large footprint to isolate a pulmonary vein in fewer applications.
Boston Scientific’s Farawave, the catheter used with its Farapulse PFA platform, is a single-shot device. Medtronic CEO Geoff Martha said at a Bernstein investor event in May that Sphere-360 “goes right at our competition.”
While Farawave has a head start over Sphere-360, Medtronic has sought to differentiate its device from the competition. Physicians need to rotate Farawave between delivering PFA to target tissue. Medtronic created Sphere-360 to provide single-shot PFA without rotation.
“The Sphere-360 catheter offers an excellent balance between ease of use and consistency in outcomes,” Tobias Reichlin, M.D., Director of Electrophysiology at Inselspital University Hospital, said in a statement. “Its design conforms to the pulmonary vein in a unique way that delivers consistent, effective and durable lesions for AFib patients, without any rotation of the catheter.”
Medtronic published one-year data in patients treated with Sphere-360 in October, linking the device to a pulmonary vein isolation time of 11.5 minutes. Data from the trial supported the CE mark filing. Medtronic CFO Thierry Pieton said at a Bank of America event in September that the procedure time for Sphere-360 is significantly shorter than for Sphere-9.
Work to generate data to support a U.S. filing is underway, with Medtronic recently completing the first cases at multiple sites in a pivotal trial. The primary completion date of the study is November 2027, per ClinicalTrials.gov.
Launching Sphere-360 is part of Medtronic’s efforts to expand its profit margins. Pieton said Medtronic’s engineering team has worked to ensure Sphere-360 “comes out with a significantly better cost base than Sphere-9,” making the new catheter a higher-margin product.
