FDA Panel Eyes New Heart Shunt Device Approval
Published Date: 11/3/2025
Notice
Summary
The FDA is hosting a virtual meeting on December 3, 2025, to discuss the V-Wave Ventura Interatrial Shunt System, a device that helps with heart blood flow. They’re inviting the public to share their thoughts by January 3, 2026, which could impact how this device is reviewed and possibly approved. This affects patients, doctors, and companies involved in heart health, with no direct costs announced yet.
Analyzed Economic Effects
5 provisions identified: 4 benefits, 0 costs, 1 mixed.
Advisory Panel Will Vote on Heart-Shunt PMA
On December 3, 2025, the FDA's Circulatory System Devices Panel will discuss, make recommendations, and vote on the premarket approval (PMA) application from V‑Wave, Inc. for the V‑Wave Ventura Interatrial Shunt System, a permanent implant indicated for New York Heart Association (NYHA) Class III heart failure patients who remain symptomatic despite guideline‑directed medical therapy.
Public Comments Accepted Through Jan 3, 2026
The FDA established docket FDA‑2025‑N‑4679 and will accept public comments through 11:59 p.m. Eastern Time on January 3, 2026. Comments submitted on or before November 14, 2025 will be provided to the Committee; later comments will be taken into consideration by FDA.
How to Request an Oral Presentation
Individuals wishing to make formal oral presentations must notify the contact person and submit a brief statement of the evidence or arguments, names/addresses of participants, and requested time by November 3, 2025; oral presentations are scheduled on December 3, 2025, between approximately 2 p.m. and 3 p.m. Eastern Time and may be time‑limited or selected by lottery if demand exceeds available slots.
Virtual Meeting with Accessibility Accommodations
The meeting will be held virtually on December 3, 2025 (9 a.m. to 6 p.m. ET) with presentations heard, captioned, recorded, and viewable online; persons requiring disability accommodations should contact CDR Daniel Bailey at Daniel.Bailey@fda.hhs.gov or 301-796-0048 at least 7 days before the meeting.
Procedure for Confidential Comment Submissions
If you want to submit confidential information, you must send a written/paper submission with two copies: one labeled "THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION" (for FDA review) and a second redacted copy for public viewing; confidential information will be handled under 21 CFR 10.20.
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