Image courtesy of Medtronic
Revenue: $31.686 million
- FDA approval of the Micra AV2 and Micra VR2 leadless pacemaker systems. According to Medtronic, these are the world's smallest pacemakers (comparable in size to a multivitamin). With 40% more battery life, most patients will only need one device for life.
- CE mark for the Affera mapping and ablation system, which includes the Sphere-9 catheter and the Affera Prism-1 mapping software. Together, Medtronic said the full system creates a new paradigm in electrophysiology through the integration of the Sphere-9 pulsed field ablation, radiofrequency (RF), and high-density mapping catheter, which maps and ablates atrial arrhythmias (fast, abnormal heart rhythms) and provides real-time feedback through mapping and navigation software.
- FDA approval of the MiniMed 780G system with the Guardian 4 sensor (shown above) and resolution of diabetes warning letter.
Anticipated catalysts: FDA approval of the PulseSelect PFA System for the treatment of atrial fibrillation supported by recent PULSED-AF data.