Medtronic announces positive results from real-world registries for the Sphere-9™ catheter and PulseSelect™ PFA System at APHRS 2026
Medtronic presented positive real-world registry results for the Sphere-9 catheter/Affera system and the PulseSelect PFA System at the APHRS 2026 scientific meeting. The APEX registry (1,050 AFib patients) showed a 1.1% major complication rate, while the REAL PULSE registry (1,160 patients) reported a 100% acute success rate with a 0.09% acute major complication rate. A separate European analysis of 46 VT patients demonstrated 87% acute success and 75% six-month freedom from VT recurrence; Sphere-9 remains investigational for VT in the U.S.
Key figures
- Vt patients
- 46
- Apex afib sites
- 28
- Real pulse sites
- 38
- Apex afib patients
- 1050
- Real pulse patients
- 1160
- Vt acute success rate
- 87%
- Apex afib complication rate
- 1.1%
- Real pulse acute success rate
- 100%
- Real pulse acute complication rate
- 0.09%
- Vt six month freedom from recurrence
- 75%
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