US Post-Market Surveillance Study of the Surfacer* Inside-Out* Access Catheter System (Surfacer System)

Merit Medical Systems, Inc.

Summary

Single arm, observational, multi-center, consecutively enrolling, post-market surveillance study. Treating patients in need of central venous access who have upper body venous occlusions or other conditions that preclude central venous access by conventional methods, and who meet the requirements described in the device labeling.

Description

Single arm, observational, multi-center, consecutively enrolling, post-market surveillance study. A minimum of 30 patients will be enrolled in the study, all cases to be performed un-proctored at up to 12 sites in the United States, with no site enrolling more than 6 subjects. All patients enrolled will sign an informed consent form for use of their data. Investigators will invite patients who will be treated with the device in accordance with the approved labeling and who met enrollment criteria to join the study.

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: 1. Subjects have been referred for placement of central venous access, i.e., placement of catheter, nutritional line, etc. 2. Subjects with upper body venous occlusions or other conditions that preclude central venous access by conventional methods 3. Subjects are willing and able to give written informed consent Exclusion Criteria: 1. Occlusion of the right femoral vein, right iliac vein or inferior vena cava 2. Acute thrombus within any vessel to be crossed by Surfacer System (SVC, jugular, IVC, brachiocephalic and subclavian) 3. Occlusion within the arterial system 4.…

Interventions

Device
Central Venous Access
The Surfacer® Inside-Out® Access Catheter System is intended to obtain central venous access to facilitate catheter insertion into the central venous system for patients with upper body venous occlusions or other conditions that preclude central venous access by conventional methods.

Locations (6)

Pima Heart and Vascular
Tucson, Arizona
Sarasota Memorial Health Care System
Sarasota, Florida
Baylor Scott & White Heart and Vascular Hospital
Dallas, Texas
The University of Texas Health Science Center at Houston
Houston, Texas
Flow Vascular Institute
Pasadena, Texas
St. Mark's Hospital
Millcreek, Utah