Edwards Lifesciences Corporation

Brian R Lowry

Arvin T Chang

Darshin S Patel

Michael R Bialas

Vipul P Rajpara

Russ Hunton

A method for preparing a prosthetic valve and a delivery system for an implantation procedure. The method comprises (a) obtaining a tray, the tray containing the delivery system, the prosthetic valve coupled to the delivery system, and a valve cover in which the prosthetic valve is disposed. The tray comprises a storage cavity comprising an open end, a floor, and a peripheral side wall defining the depth of the cavity, wherein the prosthetic valve and the valve cover are disposed in the storage cavity; and a mounting surface that substantially immobilizes and maintains the valve cover and prosthetic valve within the storage cavity. The method further comprises (b) at least partially filing the storage cavity with a first hydrating fluid to completely immerse the prosthetic valve; and (c) removing the delivery device with the prosthetic valve from the tray, including disengaging the prosthetic valve from the mounting surface.

Method and system for packaging and preparing a prosthetic heart valve and associated delivery system

A packaging system for storing a prosthetic valve and an elongated delivery system in a non-fluid environment. The packaging system includes a tray for securing both a prosthetic valve and an elongated delivery system. The tray includes a cavity sized and shaped to house a valve cover containing the prosthetic valve and at least part of the distal portion of the elongated delivery system. A mounting surface removably couples the valve cover to the cavity floor and to prevent the valve cover from moving. An engaging surface is disposed peripherally of the cavity and is elevated above the cavity floor. A ramp extends downwardly from the engaging surface and into the cavity through an opening defined in the peripheral side wall and adjacent the floor of the cavity. The engaging surface and ramp are configured to secure at least part of the elongated delivery system externally of the cavity.

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Fullerton, CA, United States of America

Brian R Lowry