Edwards Heart Valve Snags Extra Patent Review Time
Published Date: 6/25/2025
Notice
Summary
The FDA has set the official review period for the EDWARDS SAPIEN 3 ULTRA RESILIA heart valve device, helping the makers apply for extra patent time. This means the company can potentially extend their patent, giving them more time to protect their invention and possibly earn more money. Patients and competitors should watch for changes in patent status and market availability.
Analyzed Economic Effects
2 provisions identified: 1 benefits, 0 costs, 1 mixed.
FDA Sets Review Period for Valve
The FDA has determined the regulatory review period for the EDWARDS SAPIEN 3 ULTRA RESILIA premarket approval supplement (PMA 140031, S-141). This determination allows the device maker to submit applications to the U.S. Patent and Trademark Office to seek an extension of a patent that claims this medical device.
Patients, Competitors Should Watch
The notice says patients and competitors should watch for changes in the device's patent status and market availability after the FDA set the review period for EDWARDS SAPIEN 3 ULTRA RESILIA (PMA 140031, S-141). Changes in patent status could affect who sells the device and how broadly it is available.
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