Appearance
The Mapping War
CARTO's 50%+ share was built on two decades of workflow dominance and a locked ecosystem. The ecosystem got unlocked by a court. Medtronic built a catheter that doesn't need a mapping system at all.
CARTO vs Affera
Affera doesn't compete on features. It competes by making CARTO irrelevant for simple AF.
| CARTO 3 | Affera | |
|---|---|---|
| Capital cost | ~$500K | $0 (disposable) |
| FDA adverse events | 66 | 367 |
| Deaths | 2 | 5 |
| Design flaws | 0 | 24 |
| Electrical failures | 0 | 63 |
So what: CARTO has zero design flaws in two years. Affera has 24 design flaws and 63 electrical failures in year one. But hospitals choose Affera because it eliminates a $500K capital decision.
- CARTO holds: Complex cases, training, multi-catheter workflows, academic centers.
- CARTO loses: Community hospitals doing simple AF. ASCs. New programs avoiding capital.
CARTO vs BSX Mapping
Opal HDx (rebranded RHYTHMIA) now integrates with FARAWAVE NAV, giving BSC a complete PFA + mapping workflow. 6 FDA adverse events. Not a safety threat yet.
The real threat: BSC is developing Faraflex — a single catheter that maps and ablates, directly targeting Affera's model. First-in-human Feb 2025. IDE trial expected mid-2026. When it launches, BSC will have market-leading PFA and integrated mapping.
The Antitrust Reframe
The $442M judgment ended CARTO's locked ecosystem. Competitors will reference it.
The response: CARTO is now the most open and most proven platform. Compatible with reprocessed catheters ($400–800/case savings). 20 years of evidence. Open by court order — and better for it.
PFA Class-Wide Risks
Every PFA platform has these problems. J&J should surface them — J&J is the only company that also sells RF.
Hemolysis: Universal
| Platform | Hemolysis Rate |
|---|---|
| PulseSelect | 100% |
| FARAPULSE | 97% |
| VARIPULSE | 97% |
| Affera | 88% |
Published clinical data.
So what: Hemolysis is a class-wide issue, not a competitive differentiator. One FARAPULSE patient died from hemolytic renal failure. The J&J advantage: "When hemolysis risk is elevated, we switch to QDOT MICRO. Can your competitor?"
Coronary Narrowing: Not Transient
PFA near coronary arteries causes lasting changes. 2025 JACC imaging study:
- Wall area: +17% at 3 months
- Luminal area: -10% at 3 months
So what: "PFA is excellent for standard PVI. For lesions near coronary arteries, RF is safer. We offer both."
The ASC Decision
CMS added AF ablation to ASC-covered procedures in January 2026. VARIPULSE requires CARTO. ASCs won't buy a $500K system.
| Option | What It Means | Risk |
|---|---|---|
| Standalone VARIPULSE | Simplified PVI without full mapping | Engineering investment; may cannibalize CARTO |
| CARTO-lite for ASCs | Lower capital cost ($150–200K) | Margin compression |
| Concede ASCs | Focus CARTO on hospital labs | Cedes 30–40% of PFA growth |
Abbott's Volt (conscious sedation, no general anesthesia) is an ASC-native advantage. If it works, Abbott owns the segment by default.
The worst outcome is no decision. Every quarter without an ASC strategy is a quarter competitors build installed base you'll never win back.
Hemolysis: Circulation: Arrhythmia. Coronary imaging: JACC Clinical EP (2025). ASC coverage: 2026 OPPS Final Rule.