FDA Patent Review for a Pacemaker With No Leads
Published Date: 6/16/2025
Notice
Summary
The FDA has set the official review period for the AVEIR VR Leadless System, a cool medical device, so its makers can apply to extend their patent. If you think the dates are wrong or want to challenge how carefully the company worked during the review, you have until mid-2025 to speak up. This helps the company protect their invention longer, which could impact when others can make similar devices.
Analyzed Economic Effects
2 provisions identified: 2 benefits, 0 costs, 0 mixed.
FDA sets 3,109‑day review period for patent extension
FDA determined the regulatory review period for the AVEIR VR Leadless System is 3,109 days in total — 740 days in the testing phase and 2,369 days in the approval phase. This determination establishes the maximum potential length of a patent extension; the applicant is seeking 1,826 days of patent term extension.
AVEIR VR Leadless System approved for specific patients
FDA has approved the AVEIR VR Leadless System (PMA P150035) with approval dated March 31, 2022. It is indicated for patients with bradycardia (including normal sinus rhythm with rare A-V block or sinus arrest), chronic atrial fibrillation, and severe physical disability; Rate‑Modulated Pacing is indicated for chronotropic incompetence. The device is conditionally safe for MRI use per the Abbott MRI‑Ready Leadless System Manual.
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