# SAPIEN 3 Transcatheter Heart Valve: Edwards Lifesciences surgical robot

Canonical ID: `11d93de0-ecbc-40c1-9cbf-78faec650556`

- **Slug:** sapien-3-transcatheter-heart-valve
- **Form factor:** surgical
- **Maturity stage:** production
- **Lifecycle:** active
- **Deployments registered:** 0

## Deployments

_No deployments registered for this model._

## Supply chain

_No verified supply relationships on file. Supply-chain coverage is being added across the registry; check back as the seed populates this model's suppliers._

_Suppliers appear when verified with at least two strong sources. Sources are append-only; corrections add new sources rather than rewrite history._

## Incidents affecting SAPIEN 3 Transcatheter Heart Valve (1)

- [FDA Class I recall of Edwards Lifesciences arterial cannulae due to risk of wire exposure](/incidents/recall-2025-05-16-edwards-lifesciences.md), 2025-05-16 · Recall

_Includes incidents linked directly to this model or to deployments of it. Retracted incidents excluded from this view but reachable at their canonical URLs._

## 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.


## Sources (1)

1. https://en.wikipedia.org/wiki/Edwards_Lifesciences

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