European clinical experience with REPEL-CV^®

Authors: Schreiber, Christian; Boening, Andreas; Kostolny, Martin; Pines, Eli; Cremer, Jochen; Lange, Rüdiger; Scheewe, Jens

Source: Expert Review of Medical Devices, Volume 4, Number 3, May 2007 , pp. 291-295(5)

Publisher: Expert Reviews

Buy & download fulltext article:

Price: $73.00 plus tax (Refund Policy)

Abstract:

The objective of the feasability study was to gain European clinical experiences with REPEL-CV^® for reducing postoperative adhesions in pediatric patients undergoing cardiovascular surgery. The pediatric patient population included patients requiring staged cardiovascular sternotomy procedures where it was anticipated that the second sternotomy procedure would be performed 2-8 months subsequent to the initial procedure. At the time of the second sternotomy procedure, 13 out of 15 (86.7%) patients had no Grade 3 (`severe') adhesions. The mean percentage of the investigational surgical site with severe adhesions was 11%. There were five serious adverse events. All were anticipated (identified in the protocol and the investigator's brochure) and were considered by the investigators to be `definitely not related' to the study device. Based on the incidence and extent of `severe' adhesions and the safety profile for REPEL-CV as demonstrated in this study, the effectiveness and safety of REPEL-CV have been further demonstrated.

Keywords: cardiovascular postoperative adhesions; REPEL-CV; sternotomy

Document Type: Research article

DOI: http://dx.doi.org/10.1586/17434440.4.3.291

Publication date: 2007-05-01

More about this publication?

Expert Review of Medical Devices provides commentary, analysis and debate for all professionals involved in research, development, testing and clinical use of devices.
Editorial Board
Information for Authors
Submit a Paper
Subscribe to this Title
Information for Advertisers
Terms & Conditions
Information for Librarians
Free Trials
ingentaconnect is not responsible for the content or availability of external websites