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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.
Disclosure
Christian Schreiber and Jens Scheewe were involved in the REPEL-CV feasibility study and have received reimbursement from SyntheMed Inc. for their work. Eli Pines is an employee of SyntheMed and owns stocks in the company.