CLAIM #40710 · Medtronic PLC (MDT) · 2026Q1 earnings call · Aug 19, 2025 · due Dec 31, 2025
“We're expecting to start the pivotal trial for Sphere-360 this calendar year.”
Thierry Pieton · CFO
In context
“ere-9 focal catheter and a Affera mapping system. Affera mapping system utilization is high and the Sphere-9 catheters are being used in a wide variety of cases. Our teams are quickly ramping supply and our mapper hiring is on track. This is allowing us to enter new accounts as well as going deeper into more labs in our established accounts. We're still early in the rollout, and we continue to execute with urgency to capitalize on this massive opportunity. We expect to continue to win share in this $11 billion space that is now growing over 25%. As we look forward, we're advancing our PFA pipeline, including our next-gen Affera Sphere-360 catheter. We hear from many EPs that Sphere-360 is the most anticipated single-shot catheter in this space, driven by very positive early clinical data. We're expecting to start the pivotal trial for Sphere-360 this calendar year. Next, in structural heart, we grew 6%. We continued to gain traction with our Evolut FX and TAVR device and our differentiated clinical evidence. We're getting our fair share of international revenue from Boston Scientific's market exit. We're also gaining momentum in several geographies, including Japan. We expect all of this to drive continued strength in our TAVR franchise in the quarters ahead. In Cardiac Rhythm Management, we grew 3%, with 6% growth in defibrillation solutions and 3% in cardiac pacing therapies offset by cardiovascular diagnostics. We continued to see strong adoption of our premium innovative products, including 83% growth of AURORA EV-ICD, 14% growth in Micra leadless pacemakers and 21% growth with our 3830 conduction system pacing lead. In hypertension, we were ver”
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SEC filings for MDT ↗ · Claim quote is verbatim from the 2026Q1 earnings call.