Open Access. Powered by Scholars. Published by Universities.®

Biomedical Engineering and Bioengineering Commons

Open Access. Powered by Scholars. Published by Universities.®

Biomechanics and Biotransport

Electronic Theses and Dissertations

2022

Food and Drug Administration (FDA)

Articles 1 - 1 of 1

Full-Text Articles in Biomedical Engineering and Bioengineering

Pulmonary Valve Replacement, Mina Shafiei Jan 2022

Pulmonary Valve Replacement, Mina Shafiei

Electronic Theses and Dissertations

Currently, transcatheter pulmonary valve replacement (TPVR) is a well-established alternative for surgical pulmonary valve replacement (SPVR) to treat pulmonary valve disorders in patients with prior congenital heart surgery. Edwards Sapien 3 valve is a bioprosthesis originally designed for the aortic position but has been used off-label in native right ventricular outflow tract (RVOT). It is currently under clinical trial to get food and drug administration (FDA) approval.

This study is a comparison of the performance of Sapien 3 with surgical bioprosthetics. The in vitro tests result showed Sapien 3 experiences less degree of opening and effective orifice area in pulmonic …