The objective of this study is to establish reasonable assurance of safety and effectiveness for the xDot Access Management System (AMS) when used as indicated for femoral-arterial and femoral-venous closure. Additionally, this study will provide preliminary evidence on the impact on health outcomes for patients undergoing interventional catheterization procedures when the xDot AMS is used for vascular closure.
Inclusion Criteria:
Age ≥ 18 years
Willing and able to provide written informed consent prior to initiation of study procedures
Willing and able to comply with the protocol-specified procedures and assessments
Investigator opinion suitable for xDot AMS for femoral closure (arterial or venous, as applicable)
Minimum vessel diameter of 5.5 mm and vessel depth ≥1.5 cm and ≤5.0 cm, <50% stenosis for the:
Candidate for elective or planned (i.e., not emergent or urgent) percutaneous transcatheter interventional procedure through:
Exclusion Criteria:
ginny.kirby@xdotmedical.com612-720-6255
ben.smith@brightresearch.com312-972-3949
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