# 2025-11034: FDA Sets Patent Review Clock for NAVITOR Heart Valve

2025-11034, Determination of Regulatory Review Period for Purposes of Patent Extension; [NAVITOR TRANSCATHETER AORTIC VALVE IMPLANT], is a Federal Register notice from Health and Human Services Department, Food and Drug Administration published 2025-06-16; PRIA reads it as touching household money (as of 2026-11-02).

- Canonical: https://policyrisk.com/federal-register/2025-11034
- As of: 2026-11-02
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2025-11034
- Title: Determination of Regulatory Review Period for Purposes of Patent Extension; [NAVITOR TRANSCATHETER AORTIC VALVE IMPLANT]
- Type: Notice
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 90 FR 25333
- Published: 2025-06-16
- Effective: unknown
- Comments close: not stated
- Significant: no
- Touches household money: yes
- Regulation identifier numbers: none
- Last updated: 2026-11-02

## In one line

FDA Sets Patent Review Clock for NAVITOR Heart Valve

## Summary

The FDA has officially set the review period for the NAVITOR Transcatheter Aortic Valve Implant, a medical device patent up for extension. This means the company can apply to extend their patent protection based on how long the FDA took to review the device. If anyone thinks the dates are wrong or wants to challenge the company's review speed, they have until mid-December 2025 to speak up.

## Abstract

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for NAVITOR TRANSCATHETER AORTIC VALVE IMPLANT and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.

## Effects PRIA read

- NAVITOR patent eligible for extension: benefit, high. The FDA determined the NAVITOR Transcatheter Aortic Valve Implant had a 453-day regulatory review period. FDA verified the PMA was initially submitted on October 18, 2021 and approved on January 13, 2023, and the applicant (St. Jude Medical, LLC) seeks 453 days of patent term extension. This determ…
- Deadlines to challenge dates or due diligence: benefit, low. Anyone who believes the published dates are incorrect may submit comments asking for a redetermination by August 15, 2025. Any interested person may petition FDA about whether the applicant acted with due diligence during the regulatory review period by December 15, 2025, using the submission route…

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## Sources
- [2025-11034 on federalregister.gov](https://www.federalregister.gov/documents/2025/06/16/2025-11034/determination-of-regulatory-review-period-for-purposes-of-patent-extension-navitor-transcatheter)
- [2025-11034 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2025-06-16/pdf/2025-11034.pdf)

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Source: PRIA, https://policyrisk.com/federal-register/2025-11034 (as of 2026-11-02).