Deployment

SAPIEN 3 Transcatheter Heart Valve at Los Angeles, California, USA

Name: SAPIEN 3 Transcatheter Heart Valve at Los Angeles, California, USA
Start: 2019-01-01T00:00:00.000Z
Location: Los Angeles, California, USA

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.

SAPIEN 3 Transcatheter Heart Valve by Edwards Lifesciences · Catalog entry · 1 source · not yet field-verified · Surgical robots

Track SAPIEN 3 Transcatheter Heart Valve at Los Angeles, California, USA

Recent coverage

CMS Proposes TAVR Medicare Coverage is Potential Boost for Edwards LifesciencesMedTech Intelligence · 2026-06-22
FTC Challenges Anticompetitive Medical Device DealBen Smith, Deploy Editor · 2025-08-01
FDA: Edwards Lifesciences Removes Arterial Cannula due to Risk of Wire ExposureBen Smith, Deploy Editor · 2025-05-20

See all coverage →

Cedars-Sinai Medical Center, Los Angeles, is listed as a site in real-world SAPIEN 3 Ultra experience studies. Raj Makkar, MD is a key investigator.

Exposure

Customer segment: healthcare
Scale tier: commercial 10 99

Each exposure value carries its own basis marker. Aggregators report a number; this surface preserves the source class so verification depth travels with the value.

Safety record

1 recall on record (1 serious). Most recent: May 2025.

serious: 1

Most recent: May 2025

Only active incidents are counted. Retracted incidents are excluded from this summary but remain reachable at their canonical URLs.

Incidents on record (1)

FDA Class I recall of Edwards Lifesciences arterial cannulae due to risk of wire exposure2025-05-16 · Recall

Direct incidents recorded against this deployment. Retracted incidents are excluded here but remain reachable at their canonical URLs.

Trust tier: Catalog entry · 1 source · not yet field-verifiedhow tiers work →
Last updated: 2026-08-21
Model: SAPIEN 3 Transcatheter Heart Valve
Company: Edwards Lifesciences
Location: Los Angeles, California, USA
Operator: Edwards Lifesciences
Status: operational
Scale at site: 11 to 100 units
Site environment: indoor
Location precision: city centroid
First seen: 2019-01-01
ID: 1ddd3749-3f47-4b40-a33c-85e753cb100a

Timeline

Jan 2019
First recorded
SAPIEN 3 Transcatheter Heart Valve first documented operating at Los Angeles, California, USA.
Aug 2026
Current status: operational, reviewed
Latest recorded state. New status transitions append here as the deployment-status recorder produces them.

On the deployment map

Free to use on your site, with a link back to DEPLOY.

SAPIEN 3 Transcatheter Heart Valve operates in Los Angeles, California, USA. Explore the full verified map:

Sources (1)

https://www.ahajournals.org/doi/10.1161/CIRCINTERVENTIONS.121.010543

Methodology: Verified · 1 source (no primary) · last reviewed 2026-08-21

Verification posture

Verified

Low confidence

Review state

Stable

Last reviewed 2026-08-21

Maturity + lifecycle

Maturity stage: production

Lifecycle: active

Architectural position

Cohort: surgical

Sources by quality tier

1: unclassified; Unclassified source

The framework is documented at /methodology. Corrections at /corrections. Reviewer: DEPLOY editorial team.

Common questions

What is the SAPIEN 3 Transcatheter Heart Valve deployment at Los Angeles, California, USA?

SAPIEN 3 Transcatheter Heart Valve, built by Edwards Lifesciences, is recorded as a deployment at Los Angeles, California, USA on the DEPLOY registry. Edwards Lifesciences operates the deployment directly.

Who operates SAPIEN 3 Transcatheter Heart Valve at Los Angeles, California, USA?

Edwards Lifesciences, the manufacturer of SAPIEN 3 Transcatheter Heart Valve, operates this deployment directly. This is a maker-deploys-its-own-product arrangement rather than a customer pilot.

When did the SAPIEN 3 Transcatheter Heart Valve deployment at Los Angeles, California, USA go live?

The deployment is recorded as starting January 1, 2019 on the DEPLOY registry. Earlier activity may exist but is not yet sourced.

Have there been incidents at the SAPIEN 3 Transcatheter Heart Valve deployment at Los Angeles, California, USA?

1 active incident affecting this deployment is on the DEPLOY registry. Each is a sourced, append-only record; retracted incidents are suppressed from this view.

Is SAPIEN 3 Transcatheter Heart Valve at Los Angeles, California, USA safe?

SAPIEN 3 Transcatheter Heart Valve at Los Angeles, California, USA 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.

Deploy Watch

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Machine-readable surfaces

Markdown mirror: /deployments/sapien-3-transcatheter-heart-valve-los-angeles-california-usa.md
JSON-LD: embedded in this page’s head
REST API: /v1/robots/1ddd3749-3f47-4b40-a33c-85e753cb100a
Data documentation: /data
Query this programmatically: Deploy MCP