European clinical experience with REPEL-CV®

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

Research output: Contribution to journalArticlepeer-review

17 Scopus citations

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.

Original languageEnglish
Pages (from-to)291-295
Number of pages5
JournalExpert Review of Medical Devices
Volume4
Issue number3
DOIs
StatePublished - May 2007

Keywords

  • Cardiovascular postoperative adhesions
  • REPEL-CV
  • Sternotomy

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