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.

Yes. SAPIEN 3 Transcatheter Heart Valve is independently verified in real-world operation on the DEPLOY registry, confirmed at named deployment sites with primary sources: not a concept, render, or demo-only.

SAPIEN 3 Transcatheter Heart Valve is made by Edwards Lifesciences, based in Irvine, California, USA, founded in 1958.

3 verified deployments of SAPIEN 3 Transcatheter Heart Valve are on the DEPLOY registry, including at Los Angeles, California, USA, Cleveland, Ohio, USA, Vancouver, British Columbia, Canada.

SAPIEN 3 Transcatheter Heart Valve is in commercial deployment and is sold to operators; contact the manufacturer to buy, and see the pricing section for any recorded price.

On the DEPLOY registry, comparable surgical robots to SAPIEN 3 Transcatheter Heart Valve include da Vinci (and Ion), Edge Multi-Port Surgical Robot, Edison Histotripsy System, Stryker Mako SmartRobotics.

SAPIEN 3 Transcatheter Heart Valve and da Vinci (and Ion) (Intuitive Surgical · 15 deployments) are both surgical robots on the DEPLOY registry. SAPIEN 3 Transcatheter Heart Valve has 3 verified deployments on record. Compare both records for specs, safety, deployments, and verified-vs-claimed autonomy.

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 40% of surgical models tracked by the registry.

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.

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.