Evaluation of the Fortilink IBF System With TETRAfuse Technology
| Status: | Enrolling by invitation |
|---|---|
| Healthy: | No |
| Age Range: | Any |
| Updated: | 3/15/2019 |
| Start Date: | November 6, 2018 |
| End Date: | June 16, 2019 |
This is a multi-center, post-market, retrospective study to collect safety and performance
data for patients implanted with the Fortilink IBF System.
data for patients implanted with the Fortilink IBF System.
This is a multi-center, post-market, retrospective study to collect safety and performance
data for patients implanted with the Fortilink IBF System.
The study will include up to 110 patients at up to 8 US sites. All patients implanted with
the Fortilink System at a site will be included in the data collection. The goal is to
collect data for at least 100 subjects, but the sample size will be capped at 110 to ensure
that all patients at a given site are included in the analysis.
data for patients implanted with the Fortilink IBF System.
The study will include up to 110 patients at up to 8 US sites. All patients implanted with
the Fortilink System at a site will be included in the data collection. The goal is to
collect data for at least 100 subjects, but the sample size will be capped at 110 to ensure
that all patients at a given site are included in the analysis.
Inclusion Criteria:
- Patient must have had an attempted implant of the Fortilink IBF System
Exclusion Criteria:
- There are no exclusion criteria
We found this trial at
5
sites
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