Robot model
SAPIEN 3 Transcatheter Heart Valve
The SAPIEN 3 is a transcatheter aortic heart valve system used for TAVR (transcatheter aortic valve replacement) to treat severe aortic stenosis without…
- Manufacturer
- Edwards Lifesciences
- Form factor
- surgical
- Maturity
- production
- Lifecycle
- active
Overview
The SAPIEN 3 is a transcatheter aortic heart valve system used for TAVR (transcatheter aortic valve replacement) to treat severe aortic stenosis without open-heart surgery. FDA-approved for low-risk patients since August 2019, and approved for asymptomatic patients in May 2025. Includes SAPIEN 3 Ultra and SAPIEN 3 Ultra RESILIA variants.
Verified vs. claimed
- Maturity stage
- production(Full-scale production deployment with repeat customers.)
- Verified deployments
- None on file
- Sources on file
- 1 source, view all
Key facts
S&P 500 Component
Yes
Key Product
Cordella Pulmonary Artery Sensor (FDA-approved June 2024 for heart failure management)
Manufacturing
Irvine CA, Draper UT, Costa Rica, Singapore, Limerick Ireland, Moncada Spain (under construction)
Data & sources
Web sources
1
1 source backing this record.View all →
Safety record
Only active incidents are counted. Retracted incidents are excluded from this summary but remain reachable at their canonical URLs.
Incidents affecting SAPIEN 3 Transcatheter Heart Valve (1)
Includes incidents linked directly to this model or to deployments of it. Retracted incidents are excluded from this view but remain reachable at their canonical URLs.
Sources (1)
Common questions
- What is SAPIEN 3 Transcatheter Heart Valve?
- The SAPIEN 3 is a transcatheter aortic heart valve system used for TAVR (transcatheter aortic valve replacement) to treat severe aortic stenosis without open-heart surgery. FDA-approved for low-risk patients since August 2019, and approved for asymptomatic patients in May 2025. Includes SAPIEN 3 Ultra and SAPIEN 3 Ultra RESILIA variants.
- Is SAPIEN 3 Transcatheter Heart Valve actually deployed in the real world?
- SAPIEN 3 Transcatheter Heart Valve is recorded at the production stage, but DEPLOY has no deployment verified at a named site yet; vendor deployment claims are not independently confirmed here. Manufacturer capability claims should be read as claims pending independent verification.
- Who makes SAPIEN 3 Transcatheter Heart Valve?
- SAPIEN 3 Transcatheter Heart Valve is made by Edwards Lifesciences, based in Irvine, California, USA, founded in 1958.
- What are alternatives to SAPIEN 3 Transcatheter Heart Valve?
- On the DEPLOY registry, comparable surgical robots to SAPIEN 3 Transcatheter Heart Valve include da Vinci (and Ion), Epione, Hugo RAS, Mako.
- How does SAPIEN 3 Transcatheter Heart Valve compare to da Vinci (and Ion)?
- SAPIEN 3 Transcatheter Heart Valve and da Vinci (and Ion) (Intuitive Surgical · 7 deployments) are both surgical robots on the DEPLOY registry. SAPIEN 3 Transcatheter Heart Valve has 0 verified deployments on record. Compare both records for specs, safety, deployments, and verified-vs-claimed autonomy.
- Is SAPIEN 3 Transcatheter Heart Valve a top surgical?
- On DEPLOY's intelligence score, which blends verified deployments, safety, adoption, media, and IP signals, SAPIEN 3 Transcatheter Heart Valve ranks in roughly the top 42% of surgical models tracked by the registry.
- What is SAPIEN 3 Transcatheter Heart Valve's maturity stage?
- SAPIEN 3 Transcatheter Heart Valve is at the production stage on the DEPLOY maturity ladder (research, prototype, pilot, commercial, production). Production stage means high-volume manufacture and commercial-scale deployments are sustained.
- Where is SAPIEN 3 Transcatheter Heart Valve deployed?
- No verified deployments of SAPIEN 3 Transcatheter Heart Valve are currently on the DEPLOY registry. DEPLOY records deployments only when verified at a named site with a primary source; absence may reflect pre-deployment, research, or manufacturer-internal use.
- Is SAPIEN 3 Transcatheter Heart Valve safe?
- SAPIEN 3 Transcatheter Heart Valve has 1 active incident on record in the DEPLOY registry. 1 recall on record (1 serious). Most recent: May 2025. Retracted incidents are excluded from this count.
Methodology: Verified · 1 source (no primary) · last reviewed 2026-07-08
Verification posture
Verified
Low confidence
Review state
Stable
Last reviewed 2026-07-08
Maturity + lifecycle
Maturity stage: production
Lifecycle: active
Architectural position
Cohort: surgical
Sources by quality tier
- 1
- knowledge-base
- Knowledge base
The framework is documented at /methodology. Corrections at /corrections. Reviewer: DEPLOY editorial team.
Methodology surface for SAPIEN 3 Transcatheter Heart Valve.Recent coverage
SAPIEN 3 Transcatheter Heart Valve in third-party press
In the press
Recent coverage mentioning SAPIEN 3 Transcatheter Heart Valve from third-party publications. Automatically surfaced; not part of the verified registry record.
CMS Proposes TAVR Medicare Coverage is Potential Boost for Edwards Lifesciences
CMS’s proposed expansion of Medicare TAVR coverage to include select asymptomatic severe aortic stenosis patients and reduce access barriers for symptomatic patients could…
FTC Challenges Anticompetitive Medical Device Deal
The FTC challenged Edwards Lifesciences' acquisition of JenaValve, alleging it would disrupt competition for revolutionary heart condition devices.
FDA: Edwards Lifesciences Removes Arterial Cannula due to Risk of Wire Exposure
FDA issued a Class I recall for Edwards Lifesciences OptiSite Arterial Perfusion Cannula and Peripheral Femoral Arterial Cannula models due to risk of wire exposure that could…
Edwards Lifesciences Reports Fourth Quarter Results
Edwards Lifesciences reported Q4 and full-year 2025 financial results, with revenue of US.07 billion.
Edwards Lifesciences chair Michael Mussallem retires from board
Michael Mussallem retired from the Edwards Lifesciences board after 23 years as CEO and chair, having led the company since its 2000 IPO spin-off from Baxter.
Machine-readable surfaces
- Markdown mirror: /models/sapien-3-transcatheter-heart-valve.md
- JSON-LD: embedded in this page’s head
- REST API: /v1/models/11d93de0-ecbc-40c1-9cbf-78faec650556
- Revision history: /models/sapien-3-transcatheter-heart-valve/history
- Data documentation: /data
- Query this programmatically: Deploy MCP
Video
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DEPLOY Intelligence Score
34.6/ 100
6-month trend
Analysis
Thin deployment record; scale validation still in progress.
Signal flags
Dimension breakdown
DEPLOY Intelligence scores are computed from verified registry data: confirmed deployments, disclosed funding rounds, regulatory filings, active job listings, video viewership, and press coverage. Confidence ratings reflect data availability. Scores update nightly.
DEPLOY Indices — verified vs claimed
Last computed: Jul 9, 2026
Intelligence layer