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CoreValve System

by Medtronic, Inc. PMA

Active United States

PMA P130021

Overview

The CoreValve System is a percutaneously delivered aortic valve prosthesis, designed to treat severe native calcific aortic stenosis in patients deemed inoperable or at extreme surgical risk. It is classified as an aortic valve, prosthesis, percutaneously delivered and is intended for use in patients with specific anatomical and haemodynamic criteria, including an aortic valve area of less than 0.8 cm², a mean gradient of over 40 mmHg, or a peak jet velocity exceeding 4.0 m/s. The device is deployed via a catheter-based approach to replace the native aortic valve without open-heart surgery.

The CoreValve System is supplied as a sterile, single-use device and is regulated under an FDA Premarket Approval (PMA) with PMA number P130021. It is intended for use in cardiac catheterization laboratories by trained interventional cardiologists or surgeons. The system includes multiple sizes tailored to aortic annulus diameters ranging from 18 to 29 mm, ensuring compatibility with diverse patient anatomies. Storage and handling must adhere to manufacturer guidelines to maintain sterility and functionality prior to use.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP130021 Date17 Jan 2014ApprovedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA PMA Active

Recalls

4 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-0559-2021 FDA Class II initiated 23 Oct 2020
    • Terminated Z-0561-2021 FDA Class II initiated 23 Oct 2020
    • Terminated Z-0560-2021 FDA Class II initiated 23 Oct 2020

    Potential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant balloon dilatation (PID).

    • Terminated Z-2264-2015 FDA Class I initiated 15 Jul 2015

    Medtronic is recalling the EnVeo R Loading Systems because of the presence of particulate.

Specification

PMA

Full name
Medtronic CoreValve System
Generic Name
Aortic valve, prosthesis, percutaneously delivered
PMA Number
FDA Product Code
NPT
Device Class
Class III
Advisory Committee
Cardiovascular
FDA Decision
APPR Approved

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Questions

  • What specific patient criteria must be met for the CoreValve System to be considered for use?

    The CoreValve System is intended for patients with severe native calcific aortic stenosis who are symptomatic and have either an aortic valve area of less than 0.8 cm², a mean aortic valve gradient greater than 40 mmHg, or a peak aortic-jet velocity exceeding 4.0 m/s. Additionally, the patient’s aortic annulus diameter must range between 18 and 29 mm, and they must be deemed inoperable or at extreme surgical risk by a heart team, including a cardiac surgeon.

  • How is the CoreValve System supplied, and is it reusable?

    The CoreValve System is supplied as a sterile, single-use device, meaning each unit is intended for one procedure only. This ensures sterility and safety for the patient, and reuse is not recommended or supported by the manufacturer.

  • What sizes are available for the CoreValve System, and how does this accommodate different patients?

    The CoreValve System is available in multiple sizes tailored to aortic annulus diameters ranging from 18 to 29 mm. This range allows for compatibility with a diverse set of patient anatomies, ensuring a better fit and potential for effective treatment.

  • Where and by whom should the CoreValve System be deployed, and what are the key considerations for its use?

    The CoreValve System is intended for deployment in cardiac catheterization laboratories by trained interventional cardiologists or surgeons. Its use requires careful adherence to manufacturer guidelines for storage and handling to maintain sterility and functionality. The procedure is catheter-based, eliminating the need for open-heart surgery.

  • What regulatory pathway does the CoreValve System follow, and what does this mean for its use?

    The CoreValve System follows the FDA Premarket Approval (PMA) pathway, with PMA number P130021. This means it has undergone rigorous review by the FDA to ensure its safety and effectiveness for its intended use in treating severe native calcific aortic stenosis in high-risk patients. Clinicians should confirm compliance with the approved indications and guidelines.