European clinical experience with REPEL-CV.
The objective of the feasibility 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.
Schreiber
Christian
C
German Heart Center Munich, Department for Cardiothoracic Surgery, Lazarettstrasse 36, 80636 Munich, Germany. schreiber@dhm.mhn.de
Boening
Andreas
A
Kostolny
Martin
M
Pines
Eli
E
Cremer
Jochen
J
Lange
Rüdiger
R
Scheewe
Jens
J
D013504:Cardiovascular Surgical Procedures / Q000009:adverse effects*; D005060:Europe; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D026741:Physical Therapy Modalities / Q000009:adverse effects / Q000295:instrumentation*; D011183:Postoperative Complications / Q000628:therapy*; D013249:Sternum / Q000601:surgery; D000267:Tissue Adhesions / Q000628:therapy*; D016896:Treatment Outcome