xDot Medical, Inc
The objective of this study is to demonstrate safety and investigate effectiveness of the xDot Access Management System (AMS) for closure of large bore femoral-arterial and femoral-venous access sites.
The investigation is a prospective, multi-center, single-arm early feasibility study composed of two (2) distinct cohorts: femoral-arterial and femoral-venous. The purpose of this study is to demonstrate the safety and assess the effectiveness of the xDot AMS for closing the access sites of the femoral artery (femoral-arterial cohort) and femoral vein (femoral-venous cohort). This is a treatment-only early feasibility study (EFS) intended to capture and characterize outcomes, especially safety outcomes, with the xDot AMS.
Inclusion Criteria: 1. Age ≥18 years 2. Willing and able to provide written informed consent prior to initiation of study procedures 3. Willing and able to comply with the protocol-specified procedures and assessments 4. Investigator opinion suitable for xDot AMS for femoral closure (arterial or venous, as applicable) 5. Minimum vessel diameter of 5.5 mm and vessel depth ≥1.5 cm and ≤5.0 cm, \<50% stenosis for the: 1. femoral artery, as determined by computed tomography angiography (CTA) 2. femoral vein, as determined by ultrasound or angiogram. 6. Candidate for elective or planned (i.…
The xDot AMS is designed to deliver the xDot Implant Unit in the anterior wall of the target vessel to close the puncture site.
Arctuva estimate
Verify or correct the compensation shown for this listing.