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What you have, what's working, what needs fixing. Every weakness here is something a competitor already knows.
VARIPULSE: The Honest Assessment
The Deaths
Three deaths (Nov–Dec 2025). Both incidents: no device returned, no root cause.
| Old Message | New Message | Why |
|---|---|---|
| "Zero PFA deaths" | "Fewest deaths. All under investigation." | Three deaths ended the old claim. |
| "Lowest death rate" | Don't claim rate superiority. | ~3,000 procedures vs 200,000+. The math doesn't work. |
| "Best manufacturing quality" | "PulseSelect has 10x our mfg defect rate" | Per-procedure, FARAPULSE is better than VARIPULSE (14 vs 40 per 10K). Lead with PulseSelect comparison instead. |
The Recall — How to Own It
The message: "We found it first. Paused first. Fixed first. FARAWAVE had the same stroke signal and didn't pause."
The 7x Reporting Gap
VARIPULSE generates 87 FDA adverse event reports per 1,000 procedures. FARAPULSE generates 12. This means:
- Every VARIPULSE per-procedure metric is inflated ~7x relative to FARAPULSE
- The "84% injury rate" is not a clinical rate — it reflects reporting intensity, not patient outcomes
- Until J&J builds an outcomes registry, you cannot make per-procedure claims. BSC has MANIFEST-US (41,968 patients). That's the gap to close.
What VARIPULSE Can Claim Honestly
- Fewest absolute deaths (3 vs 91 FARAPULSE, 11 PulseSelect, 5 Affera)
- 100% investigation rate (0/3 uninvestigated vs 43/91 FARAPULSE)
- Proactive safety response (voluntary pause + Class I vs BSC's Class II)
- Post-update stroke rate: 0% in 800 EU patients
- Only PFA with full 3D mapping (CARTO integration)
- VA institutional adoption post-recall — $1.6M in VA procurement contracts (H2 2025), after the recall and protocol update. Institutions that evaluate safety rigorously are buying.
QDOT MICRO: The RF Anchor
~60% of EP ablations are PFA-appropriate. The other 40% — complex VT, atypical flutter, redo procedures — needs RF. Only J&J covers both.
The pitch: "PFA handles 60% of cases. We handle 100%."
PEBAX Watch
PEBAX polymer separation — catheter sheath pulling apart from electrode. Hundreds of FDA adverse events across QDOT, ThermoCool, SmartTouch. Same material, same factory. No recall yet.
Action: Quality engineering should quantify the trend by lot number and manufacturing date. If a pattern exists, issue a voluntary correction before the FDA requires one. A reactive QDOT recall would undermine the "we act first" narrative built on the VARIPULSE pause.
CARTO: The Platform
50%+ US mapping share. 66 FDA adverse events, 0 design flaws, 2 deaths in two years.
Strengths:
- 20 years of workflow integration
- Most open platform post-injunction ($400–800/case savings with reprocessed catheters)
- Zero design flaws in FDA filings
Threats:
- Affera eliminates the need for a separate mapping purchase
- ASCs won't buy $500K systems for simple PFA
- BSC's Faraflex (in development) will add integrated map+ablate to FARAPULSE
- Abbott Volt gives EnSite X a PFA anchor
Defense: CARTO wins where complexity matters. Concede simple AF in cost-sensitive settings. Defend everything else.
Portfolio Strategy
Only J&J covers both slices. BSC has PFA but no competitive RF. Medtronic has PFA but limited RF. Abbott has both but is a year behind on PFA data.
| Product | Role | What To Say | Risk To Monitor |
|---|---|---|---|
| VARIPULSE | PFA | Fewest deaths, full mapping, proactive safety | Small sample, no registry, recall history |
| QDOT MICRO | RF | "We cover 100% of cases" | PEBAX quality trend |
| CARTO | Mapping | Open + proven, 20 years | Affera displacement, ASC gap |
Pipeline: Omnypulse showed 90% freedom from AFib at 1 year with zero adverse events in a pilot study (2026 AF Symposium). Years from market, but strong early data.
One sentence: "The only EP company that covers every case — PFA for AFib, RF for complex VT, and the mapping system in 50% of US labs."
FDA adverse event data, peer-reviewed comparative studies, ESC 2025 post-IFU data. See Method.