A prosthetic heart valve configured to replace a native heart valve and having a support frame configured to be reshaped into an expanded form in order to receive and/or support an expandable prosthetic heart valve therein is disclosed, together with methods of using same. The prosthetic heart valve may be configured to have a generally rigid and/or expansion-resistant configuration when initially implanted to replace a native valve (or other prosthetic heart valve), but to assume a generally expanded form when subjected to an outward force such as that provided by a dilation balloon or other mechanical expander.

A method for replacing a native heart valve in need thereof comprises delivering to the native heart valve an apparatus comprising a valve member, a connecting member, and an anchor member suitable for anchoring the apparatus. The valve member reversibly moves between an open position and a closed position to augment or replace the function of the native valve leaflets, thereby reducing valve regurgitation. Some embodiments include a stent that is positioned in the native heart valve with the valve member disposed therein.

A prosthetic apparatus for implantation at a native valve complex includes a main body configured for placement within the native valve, at least one downstream arm and at least one upstream arm, each coupled to and disposed outside of the main body. The main body includes a compressed state for delivery and an expanded state. In the expanded state, a space exists between the downstream arm and an outer surface of the main body to receive an edge of a native valve leaflet. A portion of the downstream arm is configured to extend behind the received native leaflet and engage a downstream surface of the native valve complex while the edge of the received native leaflet is not engaged by the downstream arm. The upstream arm is configured to engage an upstream surface of the native valve complex at a location opposite the portion of the downstream arm.

The present invention relates to an implantable endoluminal graft comprised of a microporous thin-film metal covering having a plurality of openings and a structural support element underlying and physically attached to the microporous thin-film metal covering, the microporous thin-film metal covering having shape memory properties.

The present disclosure relates to an endoluminal prosthesis, such as a stent graft that includes one or more fenestrations to accommodate endovascular disease, such as an aneurysm in cases where one or more side branches is involved. In one aspect, the prosthesis includes fenestrations that are pivotable to accommodate the dynamic geometry of the aortic branches.

Thin, biocompatible, high-strength, composite materials are disclosed that are suitable for use in a prosthetic valve for regulating blood flow direction. In one aspect, the leaflet material maintains flexibility in high-cycle flexural applications, making it particularly applicable to high-flex implants such as a prosthetic heart valve leaflet. The leaflet material includes a coherent single layer and an elastomer, wherein the elastomer is present in the pores of the porous coherent single layer.

In one embodiment according to the present invention, a stent is described having a generally cylindrical body formed from a single woven nitinol wire. The distal and proximal ends of the stent include a plurality of loops, some of which include marker members used for visualizing the position of the stent. In another embodiment, the previously described stent includes an inner flow diverting layer.

An anchoring device that can be positioned within a native valve, such as the native mitral valve, to secure a replacement prosthetic valve in place. The anchoring device can comprise a docking station formed of a super elastic wire-like member defining a continuous, closed shape. The docking station can have an upper or atrial ring with at least two ring portions or half rings that are spaced apart across gaps. Descending bends from the ends of the two ring portions lead to a pair of anchors. The anchors can include oppositely-directed rounded V-shaped arms that extend generally parallel to the upper ring. When installed by a delivery device, the anchors can be located in the subvalvular space or the region/vicinity of the native leaflets and pinch the leaflets and the annulus against the upper ring which is located on the other side of the annulus.

A percutaneous heart valve prosthesis including a collapsible valve body frame has a first end and a second end. The valve body frame is formed by a plurality of sub-frame members, each sub-frame member having a general form of a diamond with acute-angled vertices and oblique-angled vertices, wherein adjacent sub-frame members are joined at the oblique-angled vertices. A flexible skirt made from a non-biologic material extends around a periphery of the valve body frame. A one-way valve including a plurality of flexible valve leaflets is positioned within the valve body frame. The first end of the valve body frame is sized to pass through a valve orifice associated with a heart valve to be replaced and the second end of the valve body frame is sized so as not to pass through a valve orifice.

A method is provided that includes implanting a first tissue-engaging element in a first portion of tissue in a vicinity of a heart valve. A second tissue-engaging element, which is connected to a third tissue-engaging element by a longitudinal sub-member, is implanted in a second portion of tissue of an annulus, and the third tissue-engaging element is implanted in a third portion of tissue of the annulus. A fourth tissue-engaging element is implanted in a portion of a blood vessel that is in contact with an atrium. While the longitudinal sub-member engages the longitudinal member at a junction therebetween, at least a first leaflet of the heart valve is drawn toward at least a second leaflet of the heart valve by adjusting a distance between the portion of the blood vessel and the first portion of tissue in the vicinity of the heart valve. Other embodiments are also described.