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Occlutech AFR use allowed per FDA's Expanded Access program.
Occlutech AFR use allowed per FDA's Expanded Access program. Each individual request is sent for FDA approval and the site's IRB approval per regulations.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Catheter implantation of Occlutech AFR device | Device |
Inclusion Criteria:
-
Exclusion Criteria:
-
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ramona Ruble | Contact | 6126449990 | ramona.ruble@occlutech.com | |
| Distribution List Distribution List | Contact | physician.requests@occlutech.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Individual Sites Across the U.S. | Available | Maple Grove | Minnesota | 55369 | United States |
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