One-Year Results of the Portico Transcatheter Aortic Heart Valve Using the Next-Generation FlexNav Delivery System.

ABSTRACT:

Background

The FlexNav delivery system (DS) features a hydrophilic coating, stability layer, and integrated sheath to facilitate valve deployment in vessel diameters ≥5.0 mm.

Methods

Data were pooled from 2 concurrent prospective, multicenter, premarket studies (PORTICO IDE [n = 147] and FlexNav EU CE Mark [n = 46]) to evaluate the safety and efficacy of the FlexNav DS to deliver the Portico valve in the Global FlexNav study. The primary end point was Valve Academic Research Consortium (VARC)-2 major vascular complication rate at 30 days. These outcomes were compared with those of the commercially available valve arm from the PORTICO IDE study.

Results

The Global FlexNav study enrolled 193 high- or extreme-risk subjects for sugery. The mean age was 84.8 years, and 59.

SUBMITTER: Fontana GP 

PROVIDER: S-EPMC11307911 | biostudies-literature | 2023 Mar-Apr

REPOSITORIES: biostudies-literature