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Method
How this report was built. What you can trust. What you can't.
Data Sources
| Source | What It Provides | Confidence |
|---|---|---|
| FDA MAUDE (2.99M events) | Adverse event counts, deaths, injuries | High for counts |
| Company-reported procedures | Denominators for per-procedure rates | Moderate (unverified) |
| MANIFEST-US registry (41,968 patients) | FARAPULSE clinical complication rates | High |
| VARISURE Safety Survey (850 procedures) | VARIPULSE post-correction safety, same-day discharge | Moderate (single survey) |
| VOLT-AF IDE (392 patients) | Abbott Volt clinical effectiveness/safety | High (IDE) |
| OMNY-AF pilot (30 patients) | Omnypulse early safety/efficacy | Low (pilot) |
| CMS Medicare data (CPT 93656) | US AF ablation volume: 74,448 beneficiaries (2023) | High for Medicare |
| LLM extraction (40% of events) | Failure modes, root causes, design flaws | Moderate |
| VA procurement (USAspending.gov) | Federal contract volumes, institutional adoption | Moderate (federal only) |
| Analyst surveys (BTIG, Citi) | Market share estimates | Low-moderate |
| 2026 AF Symposium (Feb 6, 2026) | Late-breaking clinical data | High (peer-reviewed) |
Procedure Volume Estimates
Per-procedure rates in this report use these denominators:
| Platform | Procedures | Source | Limitation |
|---|---|---|---|
| FARAPULSE | 500,000+ global | BSC earnings (cumulative, early 2026) | Global, not US-specific |
| PulseSelect | ~30,000 global est | Medtronic PR (Sept 2024: 10K+), extrapolated | Stale. Actual may differ. |
| VARIPULSE | ~40,000 global | J&J Q4 2025 earnings ("nearly 40,000 patients") | Global, not US-specific |
| Affera | Not disclosed | — | Cannot estimate rates |
| Volt | ~392 (IDE only) | VOLT-AF IDE trial | Pre-commercial |
Total US AF ablation: ~250,000 procedures (2025 estimate). Based on CMS CPT 93656: 74,448 Medicare beneficiaries (2023), ~12% annual growth, x2.5-3x all-payer multiplier. CMS does not distinguish PFA from RF ablation.
The Reporting Rate Comparison
MAUDE events per 1,000 procedures:
- FARAPULSE: 4.8
- VARIPULSE: 6.5
- PulseSelect: 34.7
The reporting gap between FARAPULSE and VARIPULSE has narrowed from 7x (at 3K procedures) to ~1.35x (at 40K procedures). This is within normal manufacturer variation. Per-procedure comparisons are now meaningful.
PulseSelect remains a significant outlier at 34.7 per 1K — consistent with its high manufacturing defect rate.
Key Limitations
- Procedure denominators are company-reported. Not independently verified. Global, not US-specific. MAUDE events are predominantly US.
- LLM extraction covers 40% of events. Root cause classification (design_flaw, user_error, unknown) is based on the extracted subset. The 60% unextracted events could differ.
- PulseSelect volume is estimated. Medtronic reported "10,000+" in Sept 2024. We estimate ~30,000 by late 2025 based on event growth trajectory. Actual may differ.
- "Death" does not equal "caused by device." MAUDE reports events where the device was involved. A death during ablation may not be device-caused. VARIPULSE's first death was likely caused by QDOT (RF), not PFA.
- VARIPULSE deaths: 3 MAUDE records, 2 patients. Two Nov 28 records are the same event filed twice. Per-patient death count is 2, not 3.
- CMS data lags 18-24 months. Most recent confirmed: CY2023. 2024-2025 volumes are projected.
- Affera volumes unknown. Medtronic reports PFA revenue but not Affera-specific procedure counts.
- VARISURE and OMNY-AF are conference data. Not yet peer-reviewed at time of writing.
Reproducible Queries
All queries run against ScanPath ClickHouse (2.99M events). PFA head-to-head:
sql
SELECT
CASE
WHEN d.brand_name ILIKE '%varipulse%' THEN 'VARIPULSE'
WHEN d.brand_name ILIKE '%farawave%'
OR d.brand_name ILIKE '%farapulse%' THEN 'FARAPULSE'
WHEN d.brand_name ILIKE '%affera%'
OR d.brand_name ILIKE '%sphere%9%' THEN 'AFFERA'
WHEN d.brand_name ILIKE '%pulseselect%' THEN 'PULSESELECT'
END as platform,
count() as events,
countIf(resulted_in_death = 1) as deaths,
countIf(root_cause = 'design_flaw') as design_flaws,
countIf(root_cause = 'manufacturing_defect') as mfg_defects
FROM spincast.events e
JOIN spincast.devices d ON e.device_id = d.id
WHERE e.event_date >= '2024-01-01'
AND platform IS NOT NULL
AND d.brand_name NOT ILIKE '%glenosphere%'
AND d.brand_name NOT ILIKE '%therasphere%'
GROUP BY platform
ORDER BY events DESC| Spec | Value |
|---|---|
| Database | ScanPath ClickHouse |
| Total events | 2.99M, deduplicated |
| LLM extraction | 40% (1.2M events) |
| Data through | January 2026 |
| Generated | February 2026 |
| Key sources | MANIFEST-US (JACC, Jan 2026), VARISURE (2026 AF Symposium), VOLT-AF IDE (2026 AF Symposium), HRS/EHRA PFA Statement (Feb 2026), CMS 2026 OPPS Final Rule |