Method

How this report was built. What you can trust. What you can't.

Data Sources

Source	What It Provides	Confidence
FDA MAUDE (2.66M 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
CMS Medicare data (CPT 93656)	US AF ablation volume: 74,448 beneficiaries (2023)	High for Medicare
LLM extraction (42% 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

Procedure Volume Estimates

Per-procedure rates in this report use these denominators:

Platform	Procedures	Source	Limitation
FARAPULSE	200,000+ global	BSC earnings ($1B+ revenue)	Global, not US-specific
PulseSelect	10,000+ global	Medtronic PR (Sept 2024)	6+ months stale
VARIPULSE	~3,000 global	J&J press release	Includes ~130 US pre-pause
Affera	Not disclosed	—	Cannot estimate rates

Total US AF ablation: ~220,000–250,000 procedures (2024 estimate). Based on CMS CPT 93656: 74,448 Medicare beneficiaries (2023), ~12% annual growth, ×2.5–3x all-payer multiplier. CMS does not distinguish PFA from RF ablation.

The MAUDE Reporting Rate Problem

MAUDE events per 1,000 procedures:

FARAPULSE: 12
PulseSelect: 104
VARIPULSE: 87

This 7x gap between FARAPULSE and VARIPULSE means every VARIPULSE per-procedure metric is inflated by reporting intensity, not clinical outcomes. Post-recall products are over-reported. Comparisons should account for this.

Key Limitations

Procedure denominators are company-reported. Not independently verified. Global, not US-specific. MAUDE events are predominantly US.
Small samples produce unreliable rates. VARIPULSE's 3,000 procedures: adding 2 deaths changes the rate by 67%.
Post-recall reporting inflation. VARIPULSE's MAUDE event count (87 per 1K procedures) is 7x FARAPULSE's (12 per 1K). All VARIPULSE per-procedure metrics are elevated.
"Death" ≠ "caused by device." MAUDE reports events where the device was involved. A death during ablation may not be device-caused.
42% extraction coverage. Failure mode analysis is based on the extracted subset. The other 58% could differ.
CMS data lags 18–24 months. Most recent confirmed: CY2023. 2024–2025 volumes are projected.

Reproducible Queries

All queries run against ScanPath ClickHouse. 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 scanpath.events e
JOIN scanpath.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	2.66M, deduplicated
Data through	January 2026
Generated	February 2026

Method ​

Data Sources ​

Procedure Volume Estimates ​

The MAUDE Reporting Rate Problem ​