Publications by authors named "Stephen Gielen"
Wire fractures in Solysafe septal occluders: a single center experience.
Catheter Cardiovasc Interv
June 2012
Objectives: To determine the incidence of device fractures (DF) after implantation of a Solysafe Septal Occluder (iSSO) and to assess the spectrum of associated problems.
Background: In August 2010, after initial unpublished reports on DF, the manufacturer issued an "urgent field safety notice," prompting all medical care providers to re-examine all patients after iSSO.
Methods: Prospective single center study.