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The Brief
For: J&J Electrophysiology Leadership | Updated: February 2026
J&J has the only complete EP lab — PFA, RF, and mapping. The installed base is small, the "zero deaths" claim expired in December, and Affera is pulling CARTO share by eliminating mapping from the equation.
The market: ~250,000 US AF ablations annually (CMS Medicare data × all-payer multiplier), growing ~12% YoY. PFA is replacing RF as the default energy source. J&J's share: 10–20% and growing slowly.
The PFA Scoreboard
| FARAPULSE | PulseSelect | Affera | VARIPULSE | |
|---|---|---|---|---|
| Est. procedures | 200,000+ | 10,000+ | Not disclosed | ~3,000 |
| Deaths | 91 | 11 | 5 | 3 |
| Deaths per 10K procedures | 4.5 | 11.0 | — | 10.0 |
| Mfg defects per 10K | 14 | 133 | — | 40 |
FDA adverse event data, Jan 2024–Jan 2026. Procedures: BSC earnings, MDT PR, J&J press release. All global.
How to read this:
- FARAPULSE has the best per-procedure rates. That's what 200,000 procedures does to a denominator.
- VARIPULSE's rates are unreliable. At 3,000 procedures, adding 2 deaths swings the rate 67%. Don't claim rate superiority.
- PulseSelect has the worst manufacturing quality. 133 defects per 10K — 10x FARAPULSE, 3x VARIPULSE. That's a real signal.
- VARIPULSE's FDA reporting rate is 7x FARAPULSE's (87 vs 12 reports per 1K procedures). Post-recall reporting inflation, not 7x worse safety. Every VARIPULSE per-procedure metric is elevated by this.
Three Things That Matter
1. "Zero Deaths" Is Gone
Three VARIPULSE deaths (Nov–Dec 2025). All under investigation. No device returned.
The comparison that works: "3 deaths, all under investigation. FARAPULSE has 91 — 43 with no investigation at all." Don't compare rates. Compare accountability.
2. FARAPULSE: 91 Deaths, 43 Uninvestigated
91 across 200,000+ procedures is ~0.05%. Consistent with BSC's published rate. The story isn't the rate — it's that 47% have no root cause and 4 were caused by a software bug (80% fatality from a product defect).
3. Affera Is the Business Model Threat
Not safety — 5 deaths, 24 design flaws in year one. The threat: when Affera enters a lab, there's no separate CARTO sale. The catheter is the mapping system. Every conversion is a CARTO loss.
What To Do
This week:
- Replace "zero deaths" messaging. New line: "Fewest deaths of any PFA platform. All under investigation." Send to every field rep.
- Brief the field on the 3 deaths. Medtronic reps will surface it first if you don't.
This quarter: 3. Build a VARIPULSE outcomes registry. BSC has MANIFEST-US (41,968 patients). J&J has nothing. You can't make per-procedure safety claims without denominator data. Start tracking every US case. Target: 1,000+ patients for a publishable dataset. 4. Focus competitive messaging on what holds up at any sample size:
- 47% of FARAPULSE deaths uninvestigated (accountability)
- 4 FARAPULSE software deaths (product defect, not complication)
- PulseSelect 133 mfg defects per 10K (worst in PFA)
- J&J is the only company with PFA + RF + mapping
- Defend CARTO at the institutional level. Affera wins on economics in simple AF. CARTO wins on complex cases. Identify the 20 hospitals most likely to evaluate Affera this quarter. Offer head-to-head workflow comparisons.
- Pick an ASC strategy. VARIPULSE requires CARTO ($500K). ASCs won't buy it. Options: (a) standalone VARIPULSE mode, (b) CARTO-lite at lower cost, or (c) concede ASCs, defend hospital labs. Every quarter without a decision is a quarter competitors build installed base you'll never win back.
- Monitor Abbott Volt monthly. FDA approved Dec 2025. Conscious sedation advantage could own ASCs. First FDA adverse event data will appear Q1–Q2 2026.
The Mapping Snapshot
| System | Parent | FDA Events | Deaths | Design Flaws | Share |
|---|---|---|---|---|---|
| CARTO 3 | J&J | 66 | 2 | 0 | ~50%+ |
| Affera | Medtronic | 367 | 5 | 24 | Growing fast |
| EnSite X | Abbott | ~100 | 0 | ~3 | Low |
| Opal HDx | BSX | 6 | 0 | 0 | Nascent |
CARTO: 20 years of evidence, zero design flaws, largest installed base. Affera doesn't compete on safety — it competes by making CARTO unnecessary for simple cases.
BSX is building toward integrated PFA + mapping: Opal HDx (rebranded RHYTHMIA) + FARAWAVE NAV, with Faraflex (single map+ablate catheter) in trials.
| Section | What It Covers |
|---|---|
| The PFA Race | Per-procedure rates, investigation gaps, adoption trends |
| The Mapping War | CARTO vs Affera, PFA class-wide risks, ASC strategy |
| Your Playbook | Portfolio assessment, what to fix, what to defend |
| Battle Cards | What to say and what not to say, by competitor |
| Method | Data sources, procedure volume estimates, limitations |
PFA market share (analyst surveys):
| Survey | BSC | Medtronic | J&J | Abbott |
|---|---|---|---|---|
| BTIG (Jan 2025) | 58% | 28% | 11% | 3% |
| Citi (Dec 2024) | 33% | 56% | 10% | — |
| BTIG projected 2026 | 48% | 29% | 20% | 3% |
Surveys disagree on BSC vs Medtronic. Agree on J&J: 10–20%, growing slowly.
FDA adverse event database (2.66M events), CMS Medicare procedure data (2021–2023), MANIFEST-US registry (41,968 patients), company earnings, analyst surveys. Through January 2026.