Kit includes coaptation aid and fixation system for repair of leaflets of a heart valve. Coaptation aid includes coaptation catheter having an expandable member at a distal end thereof adapted to be introduced to a left ventricular outflow tract of a heart via a retrograde approach. Expandable member has a delivery configuration with a reduced cross-dimension and a deployed configuration with an expanded cross-dimension adapted to contact a ventricular side of a first leaflet of a heart valve and position the first leaflet generally proximate a coapting configuration with a second leaflet. Fixation system includes a delivery catheter having a distal end, and a fixation device removably coupled to the distal end of the delivery catheter and is adapted to couple the first leaflet to the second leaflet of the heart valve. Methods for fixation of native leaflets of a heart valve using a coaptation aid also disclosed.

A catheter device for implanting a medical implant includes an actuating element configured to move with a capsule of the catheter device and to be manually operated to bring the actuating element from a first state to a second state. A first and/or second stop is included in the catheter device. The first stop is configured to limit a movement of the actuating element and therewith of the capsule in a first direction, e.g. proximal direction (P), when the actuating element is in the first state. The second stop is configured to limit a movement of the actuating element and therewith of the capsule in a second direction, e.g. distal direction (D), when the actuating element is in the first state, so as to prevent pressing of the capsule against a catheter tip of the catheter device and/or against a capsule stop of the catheter device.

Some embodiments described herein include a heart valve replacement system that may be delivered to the targeted heart valve site via a delivery catheter. In some embodiments, the heart valve replacement system can assemble a valve device after the valve device is delivered to the heart. In some embodiments, heart valve replacement system includes two anterior flaps that are separate but overlap each other.

Disclosed is an expandable sheath that can be used in conjunction with a catheter assembly to introduce a prosthetic device, such as a heart valve, into a patient. The disclosed sheaths can minimize trauma to the vessel by allowing for temporary expansion of a portion of the introducer sheath to accommodate the delivery apparatus, followed by a return to the original diameter once the prosthetic device passes through. Also disclosed is a sheath having inner and outer layers, where a folded portion of the inner layer extends through a slit in the outer layer, and a portion of the outer layer overlaps the folded portion of the inner layer and where a first polymer is disposed between the outer layer and the folded portion of the inner layer.

Aspects of the disclosure relate to storage assemblies including at least part of a delivery device and an implant. The storage assemblies are configured to trap sterilizing ethylene oxide gas using its high water solubility and converting the escaped ethylene oxide to less detrimental ethylene glycol and ethylene chlorohydrin to protect the implant from damage. In one example, the storage assembly includes an inner container housing the implant and sterilizing fluid and an outer container positioned over the inner container, wherein the outer container is at least partially filled with aqueous water. The implant may be a prosthetic heart valve. Aspects of the disclosure also relate to methods of sterilizing the storage assemblies of the disclosure.

An apparatus for hydraulic deployment and recapture of an implant includes a hydraulic implant uncovering mechanism and a hydraulic implant re-covering mechanism. The implant uncovering mechanism and the implant re-covering mechanism are independently actuateable with a fluid, and the implant uncovering mechanism is coupled to the implant re-covering mechanism by a flexible elongate tether.

A prosthetic heart valve for deployment in a native heart valve. The prosthetic heart valve includes an inner frame and a plurality of anchors extending from a distal portion of the inner frame. An outer sealing frame is positioned radially outward of the inner frame. The distal end portion of the outer frame is attached to a distal portion of the inner frame by a flexible cloth material such that the outer frame can move axially or tilt with respect to the inner frame. The anchors are shaped to capture native leaflets between the anchors and the outer frame to secure the prosthetic valve in the native heart valve. Prosthetic valve leaflets are provided in a lumen of the inner frame for allowing one way flow through the prosthetic valve, thereby replacing the function of the native heart valve.

Trays and packaging systems for a prosthesis delivery device that permit conversion from a packaged, storage/or shipping configuration to a loading configuration for the loading of a prosthesis. The prosthesis may be a prosthetic heart valve. In the packaged configuration, the delivery device can be supported within the tray, which includes a recess and at least one clip maintaining the delivery device within the recess. In the loading configuration, the delivery device can be arranged for loading of the prosthesis within a bath area of the tray. Optionally, the delivery device can be stored in the packaged configuration in a U-shape. Some embodiments include an additional recess for positioning an indeflator fluid line or tubing. Methods of use are also disclosed.

A delivery system for prosthetic heart valves are provided. The delivery system includes a flexible shaft, a distal sheath capsule configured to contain the prosthetic heart valve, an inner steerable catheter including an inner distal flex component, and an outer steerable catheter including an outer distal flex component. The inner distal flex component includes a first cut pattern and a second cut pattern distal to the first cut pattern. The outer distal flex component includes a third cut pattern. The inner steerable catheter is rotatable at least 90 degrees relative to the outer steerable catheter when the third cut pattern of the outer distal flex component is disposed over at least a portion of the first cut pattern of the inner distal flex component and each of the inner steerable catheter and the outer steerable catheter is in the flexed configuration.

Described is a prosthetic valve, comprising: an expandable stent including an inner lumen and having a first and a second end; and a spring attached to the first end of the expandable stent; wherein the expandable stent and the spring can expand radially to a desired diametric configuration in order to anchor the prosthetic valve at an implantation position in a body lumen. Related systems and methods.