2026-01574Notice

Kidney Nerve Zapper: Hypertension Device Patent Extended

Published Date: 1/27/2026

Notice

Summary

The FDA has officially set the review period for the Symplicity Spyral Renal Denervation System, a medical device used to treat high blood pressure. This means the company can apply to extend its patent, giving them more time to protect their invention and potentially earn more money. If you want to share your thoughts, you have until March 30, 2026, to send in comments.

Analyzed Economic Effects

2 provisions identified: 2 benefits, 0 costs, 0 mixed.

FDA Sets 3,161‑Day Review Period

The FDA determined the regulatory review period for the SYMPLICITY SPYRAL RENAL DENERVATION SYSTEM is 3,161 days: 2,801 days in the testing phase and 360 days in the approval phase. That determination lets the patent holder apply to the U.S. Patent and Trademark Office for patent term extension — the applicant seeks 1,491, 1,571, or 1,767 days of extension.

Public Comment and Petition Window

Anyone can submit comments on FDA's determination through https://www.regulations.gov or by mail until 11:59 p.m. Eastern Time on March 30, 2026. Under 21 CFR 60.24 and 21 CFR 60.30, interested persons may ask for a redetermination of the published dates or petition regarding whether the applicant acted with due diligence, and such petitions must be timely and meet the filing requirements described in the notice.

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Key Dates

Published Date
1/27/2026

Department and Agencies

Department
Independent Agency
Agency
Health and Human Services Department
Food and Drug Administration
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