New heart device made available through FDA expanded access

NCT ID NCT07421557

AVAILABLE Disease control Sponsor: Occlutech International AB Source: ClinicalTrials.gov ↗

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.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Contacts and locations

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Study contacts

Contact

Email: •••••@•••••
Contact

Phone: •••-•••-•••• Email: •••••@•••••

Locations

Individual Sites Across the U.S.
AVAILABLE

Maple Grove, Minnesota, 55369, United States