Efficacy and safety associated with the use of the Surfacer^® Inside-Out^® Access Catheter System: Results from a prospective, multicenter Food and Drug Administration-approved Investigational Device Exemption study.

ABSTRACT:

Purpose

Thoracic central venous obstruction is commonly associated with the use of central venous catheters. The Surfacer System to Facilitate Access in Venous Occlusions Study was an Food and Drug Administration-approved US Investigational Device Exemption study designed to evaluate the performance and safety of the Surfacer System when used to facilitate central venous access in patients with thoracic central venous obstruction.

Methods

Thirty patients were enrolled in this prospective, multicenter, single-arm study between December 2017 and May 2019. Device performance and adverse events were collected peri-procedurally and at discharge. Enrollment included 15 female and 15 male subjects with a mean age of 55.5 ± 12.9 (range: 30-79) years. Twenty-eight patients (93

SUBMITTER: Razavi MK 

PROVIDER: S-EPMC7897784 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature