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Every claim below is sourced and verbatim-ready. The "Don't Say" column is more important than the "Say" column.
What NOT to Claim
| Don't Say | Why | Say Instead |
|---|---|---|
| "Zero deaths" | Wrong. Three deaths since December 2025. | "Fewest deaths. All under investigation." |
| "Lowest death rate" | ~3,000 procedures vs 200,000+. FARAPULSE wins on rates. | "47% of FARAPULSE deaths are uninvestigated. 0% of ours." |
| "Best mfg quality" | Per procedure, FARAPULSE is better (14 vs 40 per 10K). | "PulseSelect has 10x the mfg defect rate of FARAPULSE." |
| "FARAPULSE is dangerous" | 200,000+ procedures. Physicians trust it. | "91 deaths, 43 uninvestigated. 4 from a software bug." |
| "Affera is hype" | Physicians who've used it like it. | "24 design flaws, 63 electrical failures in year one." |
| "PFA is safer than RF" | PFA has class-wide risks (hemolysis, coronary narrowing). | "PFA eliminates esophageal fistula. We offer both PFA and RF." |
vs FARAPULSE (Boston Scientific)
"They Have 200,000 Procedures"
"More procedures, more data — fair. So why are 43 of 91 deaths uninvestigated? No device returned. No root cause. And 4 patients were killed by a software bug. That's a product defect, not a complication."
Don't compare per-procedure rates. FARAPULSE's denominator is 67x larger — rates will always favor them. Compare accountability.
"VARIPULSE Had a Class I Recall"
"We found a 3% stroke rate in 132 patients. Paused immediately. Updated the protocol. Zero strokes in 800 European patients since. FARAWAVE was recalled for the same signal — Class II, not Class I. They didn't pause."
"FARAPULSE Works Without Mapping"
"Standalone is fast for simple AF. For complex cases, redos, and training — do you want to ablate without 3D visualization?"
Software Deaths (Use Selectively)
For technical physicians in competitive evaluations only:
"Five FARAPULSE events flagged as software design flaws. Four patients died. 80% fatality from a bug in a cardiac device."
vs Affera / Sphere-9 (Medtronic)
"Affera Replaces CARTO"
"For simple AF, Affera works. For complex cases, redos, multi-catheter workflows, training — CARTO is the only proven platform. 20 years of evidence, zero design flaws. Affera has 24 design flaws and 63 electrical failures in year one."
Next step: Offer a case observation at a site running both. Let the physician compare workflows.
"PulseSelect Is Cleaner"
"PulseSelect has the worst manufacturing defect rate in PFA — 133 per 10,000 procedures. That's 10x FARAPULSE. And they're losing volume to Affera internally — down 46% in two quarters."
vs Abbott (Volt PFA)
"Abbott Has PFA Now"
"Volt launched in December. Zero long-term data. VARIPULSE has 3,000+ procedures globally. FARAPULSE has 200,000+. Volt hasn't earned the comparison yet."
Volt's conscious sedation advantage is real. Don't dismiss it. But it's a year-one product.
Handling Objections
| Objection | Response |
|---|---|
| "3 deaths" | "3, all investigated. FARAPULSE: 91, 43 uninvestigated." |
| "Class I recall" | "Proactive pause. 0% stroke in 800 EU patients post-update." |
| "14x microemboli" | "Updated IFU. Zero strokes in 800 post-update patients." |
| "84% injury rate" | "Reporting inflation (87 reports per 1K procedures vs 12 for FARAPULSE). Not a clinical rate." |
| "FARAPULSE dominance" | "91 deaths. 43 uninvestigated. 4 from software bugs." |
| "Affera threat" | "24 design flaws, 63 electrical failures in year one. Great for simple AF. Not for complex." |
| "No ASC play" | "Working on it. CARTO wins in hospital labs where the high-value cases live." |
| "Abbott Volt" | "Brand new. Zero data. Conscious sedation is interesting but unproven at scale." |
All competitive claims sourced from FDA adverse event data with estimated per-procedure rates. Clinical data from peer-reviewed studies. See Method.