Key result
SAFEX device successfully seals 21-Fr apical access sites without bleeding or dislodgement in a pig model.
Population
5 pigs (mean weight: 67 ± 6 Kg) under general anaesthesia and full heparinization
Design
Preclinical
Follow-up
1 hour (Phase 1) plus Phase 2 duration
Authors
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Successful apical sealing in pigs under hypertension; leaves open translation to human transapical procedures.
A novel self-expandable apical closure device successfully sealed large-sized apical access sites in a porcine model, even under induced systemic hypertension, supporting its potential for full-percutaneous transapical valve procedures.
Ferrari et al. (2016) studied Transapical valve implantation (animal model) (n=5). Self-expandable apical closure device (SAFEX TM) was evaluated on Apical sealing properties (blood loss and plug dislodgement). In a pig model, the SAFEX apical closure device successfully sealed 21-Fr apical access sites without dislodgement or bleeding during both standard hemodynamics and induced systemic hypertension.
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