New heart device made available through FDA expanded access

NCT ID NCT07421557

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This program allows patients to receive Occlutech's atrial flow regulator, a device implanted via catheter to help control blood flow between the upper chambers of the heart. It is available under the FDA's Expanded Access program for those who meet eligibility criteria. The goal is to provide access to this device for patients who may not have other treatment options.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance
Occlutech atrial flow regulator device
What this could lead to
If successful, this device may help manage certain heart conditions by regulating blood flow between the atria.
What could go wrong
This is an expanded access program, not a formal trial, so data on safety and effectiveness are limited. The device may not work for all patients and carries procedural risks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Contacts and locations

Locations

  • Individual Sites Across the U.S.

    AVAILABLE

    Maple Grove, Minnesota, 55369, United States