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A prospective, multi-center, single-arm, study to evaluate the performance and safety of the LIBERTY® Robotic System in human subjects undergoing Peripheral Vascular Interventions. The study is designed to evaluate the performance and safety of endovascular procedures supported by the LIBERTY® Robotic System. The System is configured to deliver and manipulate third-party commercially available surgical devices that are employed in endovascular transcatheter procedures (guidewires, microcatheters, and guiding catheters).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endovascular Robotic Navigation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The LIBERTY® Robotic System | Device | The LIBERTY® Robotic System is intended for use in the remote delivery and manipulation of guidewires and catheters, and remote manipulation of guide catheters, to facilitate navigation to anatomical targets in the peripheral vasculature. The LIBERTY® Robotic System is not intended for coronary or neurointerventional procedures. |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness Endpoint | Successful robotic navigation of the guidewire and microcatheter is defined as reaching at least 95% of the predetermined anatomical target locations using the LIBERTY® Robotic System, without switching from a robotic to manual procedure due to difficulty reaching the target site. | During navigation portion of the procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Endpoint | Safety of the LIBERTY® Robotic System will be evaluated by the number and rate of Adverse Device Effects (ADEs) reported | Through the three (3) day follow-up visit period. |
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Inclusion Criteria:
The subject is age 22-80 years at screening.
The subject has been informed of the nature of the study and is willing and able to provide informed consent to participate in the study.
The subject has a clinical indication for an elective PVI.
The subject is willing and able to comply with all required study procedures.
Subject's scheduled procedure is compatible with commercially available peripheral interventional devices that have the following diameter ranges:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baptist Hospital of Miami | Miami | Florida | 33176 | United States | ||
| Brigham and Women's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41692299 | Derived | Cornelis FH, Gandhi RT, Rabkin D, Diaz-Cartelle J. In Vivo Evaluation of a Disposable Endovascular Robotic System for Arterial Peripheral Vascular Interventions: A Multicenter Feasibility Study. J Vasc Interv Radiol. 2026 May;37(5):108591. doi: 10.1016/j.jvir.2026.108591. Epub 2026 Feb 13. |
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|
| Boston |
| Massachusetts |
| 02115 |
| United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 2, 2025 | Dec 16, 2025 | 4 |