Dive Brief:
- Medtronic received a CE mark for its single-shot pulsed field ablation (PFA) system, paving the way for the company to expand its portfolio of European atrial fibrillation devices.
- The CE mark covers the PulseSelect System. Medtronic previously received a CE mark for Affera, which integrates PFA with radiofrequency to treat abnormally fast heart rhythms. Medtronic is now the only company to offer two approaches to PFA.
- PulseSelect’s CE mark coincided with the clearance of the Nitron CryoConsole in Europe. The CE mark for Nitron covers the use of the console with Medtronic’s cardiac cryoablation catheters.
Dive Insight:
Boston Scientific’s Farapulse became the first CE marked PFA device early in 2021. That product uses a catheter designed for single-shot isolation of the pulmonary veins. Using focal, rather than single-shot, ablation could enable the placement of other linear lesions. Medtronic established a foot in both camps by buying Affera to complement its existing work on PulseSelect.
Affera won a CE mark in March, providing a focal catheter alternative to Boston Scientific’s single-shot approach. Now, Medtronic has expanded its portfolio by adding a single-shot challenger to Farapulse.
Analysts have delivered a mixed verdict on the prospects of Medtronic’s PulseSelect in what looks set to be a highly competitive market. BTIG analysts called the safety profile seen in a single-arm trial of PulseSelect “impressive,” highlighting the “zero esophageal complications, no evidence of [pulmonary valve] stenosis and no reported evidence of phrenic nerve injury” as strengths.
Mohit Turagam, a cardiac electrophysiologist who spoke with the analysts, said the results were similar to data from Johnson & Johnson and Boston Scientific.
Still, J.P. Morgan analyst Robbie Marcus has told investors he is “more bullish on Affera and Boston Scientific’s Farapulse,” arguing that they are “both built with PFA in mind” and therefore have “a slight edge in terms of efficacy and usability in our view.”
The CE mark for PulseSelect sets up a commercial resolution to the debate by clearing physicians in the European Union to choose between the three PFA devices. The European market is a warm-up for the larger upcoming competition for market share in the U.S., where Farapulse and PulseSelect could be authorized for use next year.
Stifel analysts see the devices as a threat to Abbott’s electrophysiology unit.