FDA Patent Clock Ticks for a Device Named Smart Assist
Published Date: 6/16/2025
Notice
Summary
The FDA has officially set the review period for the IMPELLA RP FLEX WITH SMART ASSIST medical device, which helps the company extend its patent protection. If you think the dates are wrong or want to challenge the company's review efforts, you have until mid-2025 to speak up. This means the company could get more time to protect their invention, potentially affecting competition and innovation timing.
Analyzed Economic Effects
3 provisions identified: 3 benefits, 0 costs, 0 mixed.
Device approval and clinical indication confirmed
FDA approved IMPELLA RP FLEX WITH SMART ASSIST for marketing, indicated to provide temporary right ventricular support for up to 14 days in patients with a body surface area >= 1.5 m2 who develop acute right heart failure or decompensation after specified events. FDA verified the PMA approval date as October 28, 2022.
FDA finds 212‑day review period
FDA determined the regulatory review period for IMPELLA RP FLEX WITH SMART ASSIST is 212 days (0 days testing phase and 212 days approval phase). The applicant (Abiomed Inc.) submitted a PMA on March 31, 2022, the PMA was approved on October 28, 2022, and the applicant seeks 212 days of patent term extension for U.S. Patent Nos. 9,402,942; 9,750,861; and 11,007,350.
Opportunity to challenge review dates
If you think any published dates are incorrect, you may submit electronic or written comments asking for a redetermination by August 15, 2025. Additionally, any interested person may petition FDA under 21 CFR 60.30 to challenge whether the applicant acted with due diligence during the regulatory review period by December 15, 2025.
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