Abstract: Described embodiments are directed toward centrally-opening, leaflet valve devices and systems for transcatheter delivery having a two-piece valve body as well as methods of making and delivering the two-piece valve devices. A transcatheter valve comprises a collapsed configuration and an expanded configuration. The transcatheter valve can further comprise an everted configuration and a non-everted configuration.

Abstract: Described embodiments are directed toward centrally-opening, leaflet valve devices and systems for transcatheter delivery having a two-piece valve body as well as methods of making and delivering the two-piece valve devices. A transcatheter valve is operable to have a collapsed configuration and an expanded configuration. The transcatheter valve can further be operable to have an everted configuration and a non-everted configuration.

Abstract: Described embodiments are directed toward prosthetic valves having leaflets of a particular shape that improves bending character without requiring a long length valve. In accordance with an embodiment, a prosthetic valve comprises a leaflet frame, a plurality of leaflets that are coupled to the leaflet frame, where each leaflet has a free edge and a base. The base of each leaflet is truncated in which the leaflet in cross section shows a line in an alpha plane onto the leaflet frame.

Abstract: Described embodiments are directed toward prosthetic valve leaflets of particular configurations that control bending character. In embodiments provided herein, a valve leaflet is provided with a planar zone that is bounded at a planar zone base by a straight line, wherein the leaflet is operable to bend along a base of the planar zone.

Abstract: Described embodiments are directed toward prosthetic valves having leaflets of a particular shape that improves bending character without requiring a long length valve. In accordance with an embodiment, a prosthetic valve comprises a leaflet frame, a plurality of leaflets that are coupled to the leaflet frame, where each leaflet has a free edge and a base. The base of each leaflet is truncated in which the leaflet in cross section shows a line in an alpha plane onto the leaflet frame.

Abstract: A thin, biocompatible, high-strength, composite material is disclosed that is suitable for use in various implanted configurations. In one aspect, the composite material maintains flexibility in high-cycle flexural applications, making it particularly applicable to high-flex implants such as a prosthetic heart valve leaflet. The composite material includes a porous expanded fluoropolymer membrane and an elastomer, wherein the elastomer is present in the pores of the porous expanded fluoropolymer.

Abstract: A thin, biocompatible, high-strength, composite material is disclosed that is suitable for use in various implanted configurations. The composite material maintains flexibility in high-cycle flexural applications, making it particularly applicable to high-flex implants such as a prosthetic heart valve leaflet. The composite material includes at least one porous expanded fluoropolymer layer and an elastomer present in the pores of the porous expanded fluoropolymer.

Abstract: According to one aspect of the disclosure, an embolic protection device is provided comprising an elongate element having a deflector at its distal end. The embolic protection device is generally configured to redirect and/or funnel embolic debris and permit at least a portion of the blood, no longer containing the redirected and/or funneled embolic debris, to perfuse the surrounding vasculature and/or tissue.

Abstract: 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.

Abstract: Described embodiments are directed toward prosthetic valve leaflets of particular configurations that control bending character. In embodiments provided herein, a valve leaflet is provided with a planar zone that is bounded at a planar zone base by a straight line, wherein the leaflet is operable to bend along a base of the planar zone.

Abstract: Methods are provided to make a prosthetic valve having a thin, biocompatible, high-strength, composite material. In one aspect, the composite material maintains flexibility in high-cycle flexural applications, making it particularly applicable to high-flex implants such as a heart valve leaflet. The composite material includes a porous expanded fluoropolymer membrane and an elastomer, wherein the elastomer is present in the pores of the porous expanded fluoropolymer.

Abstract: Methods are presented that provide a thin, biocompatible, high-strength, composite material that is suitable for use in prosthetic valves. The composite material maintains flexibility in high-cycle flexural applications, making it particularly applicable to prosthetic valve leaflets. The composite material includes more than one porous expanded fluoropolymer layer and an elastomer present in the pores of the porous expanded fluoropolymer.

Abstract: A thin, biocompatible, high-strength, composite material is disclosed that is suitable for use in various implanted configurations. In one aspect, the composite material maintains flexibility in high-cycle flexural applications, making it particularly applicable to high-flex implants such as heart pacing lead or heart valve leaflet. The composite material includes a porous expanded fluoropolymer membrane and an elastomer, wherein the elastomer fills substantially all of the pores of the porous expanded fluoropolymer, and the composite material comprising less than about 80% fluoropolymer by weight.

Abstract: A thin, biocompatible, high-strength, composite material is disclosed that is suitable for use in various implanted configurations. The composite material maintains flexibility in high-cycle flexural applications, making it particularly applicable to high-flex implants such as heart pacing lead or heart valve leaflet. The composite material includes at least one porous expanded fluoropolymer layer and an elastomer substantially filling substantially all of the pores of the porous expanded fluoropolymer.

Abstract: Described embodiments are directed toward prosthetic heart valve leaflets of particular shapes that control bending character. In accordance with an embodiment, a prosthetic heart valve comprises a leaflet frame having a generally tubular shape with attached film. The leaflet frame defines a plurality of leaflet windows. The film defines at least one leaflet extending from each of the leaflet windows. Each leaflet attachment zone on the leaflet frame has substantially the shape of an isosceles trapezoid having two leaflet sides, a leaflet base and a leaflet free edge opposite the leaflet base. The two leaflet sides diverge from the leaflet base, wherein the leaflet base is substantially flat.

Abstract: A leaflet for a prosthetic valve formed of at least one layer that includes a composite material containing at least one expanded fluoropolymer membrane having serpentine fibrils and an elastomer is provided. The fluoropolymer may be polytetrafluoroethylene. In at least one embodiment, the elastic properties are present in an axial direction the leaflet. The leaflets may be single layered or multi-layered. The leaflets may be coupled to a support structure and movable between open and closed configurations relative to the support structure to form a heart valve. The elasticity within the leaflets permits, among other things, the leaflets to bend with a reduced occurrence of wrinkles as the valve opens and closes. The elastic properties of the leaflet also, among other things, improve bending properties and reduce closure stresses, thereby extending the life of the leaflet.

Abstract: Described embodiments are directed toward prosthetic valves having leaflets of a particular shape that improves bending character without requiring a long length valve. In accordance with an embodiment, a prosthetic valve comprises a leaflet frame, a plurality of leaflets coupled to the leaflet frame, where each leaflet has a free edge and a base. The base of each leaflet is truncated in which the leaflet in cross section shows a line in an alpha plane onto the leaflet frame.

Abstract: Described embodiments are directed toward prosthetic heart valve leaflets of particular shapes that control bending character. In accordance with an embodiment, a prosthetic heart valve comprises a leaflet frame having a generally tubular shape with attached film. The leaflet frame defines a plurality of leaflet windows. The film defines at least one leaflet extending from each of the leaflet windows. Each leaflet attachment zone on the leaflet frame has substantially the shape of an isosceles trapezoid having two leaflet sides, a leaflet base and a leaflet free edge opposite the leaflet base. The two leaflet sides diverge from the leaflet base, wherein the leaflet base is substantially flat.

Abstract: Embodiments provided herein are related to prosthetic heart valve leaflets comprising one or more imageable elements that allow for visualization of the movement of the leaflets using imaging techniques, such as, but not limited to fluoroscopy, x-ray, ultrasound, and MRI. When visualized using visualization techniques, the movement of the imageable element is directly related to the movement of the leaflet to which it is coupled, and therefore the movement of the leaflet may be determined.

Abstract: The present invention provides a leaflet for use in a prosthetic valve that stabilizes the motion of the leaflet as it moves between a closed position and an open position. In accordance with embodiments, a prosthetic valve is provided with a leaflet that contains a stiffening element between layers of film from which the leaflet is made.