Medical technology3 min read

Transcatheter aortic valve replacement

TAVRTAVI

Organ or systemHeartOrgan

Detail level

Transcatheter aortic valve replacement treats aortic stenosis by placing a replacement valve made from animal tissue inside the old valve through a catheter, without open-heart surgery. The FDA first approved a device in 2011 and expanded use to low-surgical-risk patients in 2019.

The catheter carries a folded replacement valve that is fixed firmly inside the old valve. The first device was approved in 2011 for patients not eligible for open-heart surgery, then the indications were expanded in 2019 to include people with symptomatic calcific aortic stenosis at low surgical risk.

Its risks include the need for a permanent pacemaker because of damage to the heart's electrical system during the procedure, bleeding or damage at the catheter insertion site, and stroke. According to MedlinePlus, it is not yet clear how long the new valves will keep working.

Where it stands today — maturityApproved for specific uses¹²

In widespread clinical use
Approved for specific uses
In clinical trials
Preclinical
Concept

FDA-approved since 2011 for aortic valve stenosis, with the indications expanded in 2019.

Aortic valve stenosisApproved for specific uses
It began for those ineligible for surgery (2011), then included those at low surgical risk (2019).¹²

Status last checked: 2026-10-08 · What the maturity levels mean

What is it?

A procedure that replaces an aortic valve that is not working well, or is diseased, with a valve made from animal tissue.

How does it work?

The catheter carries a folded replacement valve that is fixed firmly inside the old valve, without the need for open-heart surgery.

Where is it used today?

It treats aortic valve stenosis, one of the heart valve diseases; it is handled by the cardiology team.

The FDA approved the first device in 2011 for those ineligible for open-heart surgery, and the indications were expanded in 2019 to those at low surgical risk.

Limits and risks

Its risks include the need for a permanent pacemaker, bleeding at the catheter site, and stroke.

It is not yet clear how long the new valves will keep working.

Common questions

Is this procedure suitable for every patient with aortic valve stenosis?

The heart team decides this according to the patient's condition and the surgical risk; the indications have expanded since 2019 to include those at low surgical risk.²

Questions for your doctor

Is valve replacement by catheter or by surgery best for me, and why?
What follow-up is needed after the procedure?

References

1
U.S. FDA. FDA Facts: Postmarket Patient Registry Ensures Access to Safe and Effective Devices. www.fda.gov/about-fda/innovation-fda/fda-facts-postmarket-patient-registry-ensures-access-safe-and-effective-devices
Health agencies & guidelines · Accessed 2026-10-08
2
U.S. FDA. Clinical Outcome Assessments Complement Evidence in Label Expansion for Transcatheter Aortic Valve Replacement. fda.gov/about-fda/clinical-outcome-assessments-coas-medical-device-decision-making/clinical-outcome-assessments-complement-evidence-label-expansion-transcatheter-aortic-valve
Health agencies & guidelines · Accessed 2026-10-08
3
NHLBI (NIH). Transcatheter Aortic Valve Replacement (TAVR). www.nhlbi.nih.gov/health/tavr
Health agencies & guidelines · Accessed 2026-10-08
4
MedlinePlus (NLM). Transcatheter aortic valve replacement. medlineplus.gov/ency/article/007684.htm
Health agencies & guidelines · Accessed 2026-10-08

Review status: Edited content · Last updated: 2026-10-08

Change log

2026-10-08 — Page created.

Educational content only — no diagnosis, and no substitute for a clinician.