Abstract: Described is a device for evaluating a heart valve annulus in order to choose a particular annuloplasty device to be attached to the annulus, wherein the annuloplasty device has an inter-trigonal or inter-commissural distance and an anterior-posterior ratio, the device comprising: a valve sizing element having one of a plurality of inter-trigonal or inter-commissural distances and comprising a plurality of indicia on the valve sizing element corresponding to a plurality of anterior-posterior ratios and used to compare to the annulus in order to indicate an anterior-posterior ratio of the annulus. Adjustable devices for evaluating a plurality of anterior-posterior ratios are also described. Also, methods of sizing a patient's heart valve annulus are described.

Abstract: A replacement prosthetic heart valve for engagement with a structure of an original prosthetic heart valve that includes at least one visually detectable marker. The replacement heart valve includes a stent structure having a generally tubular body portion and at least one visually detectable marker on a portion of the stent structure, and at least two leaflets attached within the interior area of the tubular body portion of the stent structure. At least one visually detectable marker of the stent structure is alignable with at least one visually detectable marker of the original prosthetic heart valve.

Abstract: A prosthetic heart valve system including a prosthetic heart valve and a deflection device. The deflection device includes a line and a connector assembly including a tensioning component. The line interconnects and passes through free ends of stent posts associated with the heart valve, and is further connected to the tensioning component. The tensioning component is transitionable to a tensioning state in which the line is tensioned to inwardly deflect the stent posts. In this regard, the tensioning component is self-locking relative to the line in the tensioning state, and an entirety of the line extending distal the tensioning device does not extend beyond a stent portion of the heart valve opposite the stent posts. In a preferred embodiment, a holder body is further included, coupled to the heart valve apart from the deflection device.

Abstract: Annuloplasty device for implantation adjacent an annulus of a tricuspid valve, the annulus comprising anterior, posterior and septal aspects adjacent anterior, posterior and septal leaflets, respectively, of the tricuspid valve, the device comprising: a ring body comprising: an anterior portion, a posterior portion and a septal portion shaped to conform to, and for implantation adjacent, the anterior, posterior and septal aspects of the annulus, respectively; and first and second ends; wherein the ring body is curvilinear, with substantially no flat portions, forming a shape, and the ends are configured such that when the device is implanted, the first end will be located near the junction of the septal and anterior aspects of the annulus and the second end will be located near the septal aspect of the annulus. Related methods.

Abstract: A valve repair system, preferably including an annuloplasty prosthesis and a holder for the prosthesis. The holder includes a first component having a central opening, a circumferential surface and an outwardly extending member. The annuloplasty prosthesis is located adjacent to the circumferential surface, above the outwardly extending member. The holder further includes a second component movable upwardly relative to the first holder component and includes a rigid penetrating member extending downward from the second component into the prosthesis, holding it adjacent the circumferential surface. The holder also includes a suturing guide for assisting a physician in valve repair surgery, which may be a cuttable suture extending across the central opening along a path approximating a desired line of leaflet coaption. The cuttable suture may additionally secure the first and second components to one another.

Abstract: A valve system including an aortic valve and a holder. The holder includes a holder body, which has a central portion, engagable with a holder handle, and downwardly extending leg portions that engage the valve in the areas between the commissure posts. The central portion of the holder further includes a spool located between the commissure posts, rotatable by an attached handle. Rotation of the spool draws in a tensile member passing through the commissure posts, drawing the commissure posts inward toward the spool. The tensile member passes through guides formed in the holder, configured such that they define the maximum available inward deflection of the commissure posts at the point at which the portions of the tensile member between the commissure posts assume straight configurations.

Abstract: A method of percutaneously delivering a multi-layered stent assembly to a desired implantation location of a patient including the steps of radially compressing a multi-layered stent assembly to a compressed size for implantation in a patient, the multi-layered stent assembly including a first stent, a second stent coaxially positioned within at least a portion of a length of the first stent, and a valve, wherein the first stent comprises at least one different material property than the second stent. The method further includes delivering the multi-layered stent assembly to the desired implantation location of the patient using a delivery system and substantially simultaneously expanding the first stent and the second stent of the multi-layered stent assembly at the desired implantation location to a radially expanded size that is larger than the compressed size.

Abstract: A replacement prosthetic heart valve for engagement with a structure of a previously implanted prosthetic heart valve. The replacement heart valve includes a stent structure including a generally tubular body portion with an interior area and a series of wire portions arranged in a mesh-like configuration, and at least one stent post engaging structure extending radially outwardly from the body portion for engaging with an outer surface of a stent post of the previously implanted prosthetic heart valve. The stent structure further includes at least two leaflets attached within the interior area of the tubular body portion of the stent structure.

Abstract: A delivery system and method for positioning and partially deploying a replacement valve at an implantation site, verifying the location of the replacement valve relative to the implantation site, and retrieving the partially deployed stent for repositioning relative to the implantation site.

Abstract: A method of delivering a replacement prosthetic valve to a previously implanted prosthetic valve including the steps of compressing a replacement prosthetic valve having an expandable stent within a sheath of a delivery system, wherein the delivery system comprises a proximal end, a distal end, and a centering structure positioned between the proximal and distal ends, advancing the delivery system and compressed replacement prosthetic valve into a vessel of a patient until the distal end of the delivery system is positioned adjacent to a second side of a previously implanted prosthetic valve, deploying the centering structure to radially reposition the distal end of the delivery system, further advancing the delivery system toward the previously implanted prosthetic valve, and deploying the replacement prosthetic valve

Abstract: A replacement prosthetic heart valve for engagement with a structure of a previously implanted prosthetic heart valve, the replacement heart valve including a stent structure and at least two leaflets attached within the interior area of a tubular body portion of the stent structure. The stent structure includes a generally tubular body portion having an interior area, at least two upper flange portions for positioning at an outflow end of the previously implanted heart valve, wherein the upper flange portions extend radially outward from the tubular body portion and are biased toward an inflow end of the replacement heart valve, and at least one lower flange portion for positioning at an inflow end of the previously implanted heart valve, wherein the lower flange portions extend radially outward from the tubular body portion and are biased toward an outflow end of the replacement heart valve.

Abstract: An annuloplasty band comprising a sheath, and a generally arcuate stiffening element disposed within the sheath. The stiffening element extends from a first end to a second end, and preferably includes eyelets at its first and second ends adapted to receive sutures to secure the annuloplasty band to a valve annulus. The annuloplasty band preferably has a low profile (e.g., a thickness less than 3 mm). In embodiments intended for mitral valve repair, the eyelets are particularly adapted to receive sutures to secure the annuloplasty band to the antero-lateral trigone and postero-medial trigone. A holder and sizer device useful with the annuloplasty band are also provided.

Abstract: An annuloplasty band comprising a sheath, and a generally arcuate stiffening element disposed within the sheath. The stiffening element extends from a first end to a second end, and preferably includes eyelets at its first and second ends adapted to receive sutures to secure the annuloplasty band to a valve annulus. The annuloplasty band preferably has a low profile (e.g., a thickness less than 3 mm). In embodiments intended for mitral valve repair, the eyelets are particularly adapted to receive sutures to secure the annuloplasty band to the antero-lateral trigone and postero-medial trigone. A holder and sizer device useful with the annuloplasty band are also provided.

Abstract: A compressible and expandable stent assembly for implantation in a body lumen such as a mitral valve, the stent assembly including at least one stent barrel that is shaped and sized so that it allows for normal operation of adjacent heart structures. One or more stent barrels can be included in the stent assembly, where one or more of the stent barrels can include a cylinder with a tapered edge.

Abstract: A method of functionally replacing a previously implanted prosthetic heart valve. The method includes positioning a replacement prosthetic heart valve within an internal region defined by the previously implanted prosthetic heart valve. The replacement prosthetic heart valve is then physically docked to the previously implanted prosthetic heart valve. With this technique, the previously implanted prosthetic heart valve serves as a platform for securement of the replacement prosthetic heart valve to the patient's native tissue.

Abstract: A method of functionally replacing a previously implanted prosthetic heart valve. The method includes positioning a replacement prosthetic heart valve within an internal region defined by the previously implanted prosthetic heart valve. The replacement prosthetic heart valve is then physically docked to the previously implanted prosthetic heart valve. With this technique, the previously implanted prosthetic heart valve serves as a platform for securement of the replacement prosthetic heart valve to the patient's native tissue.

Abstract: An annuloplasty band comprising a sheath, and a generally arcuate stiffening element disposed within the sheath. The stiffening element extends from a first end to a second end, and preferably includes eyelets at its first and second ends adapted to receive sutures to secure the annuloplasty band to a valve annulus. The annuloplasty band preferably has a low profile (e.g., a thickness less than 3 mm). In embodiments intended for mitral valve repair, the eyelets are particularly adapted to receive sutures to secure the annuloplasty band to the antero-lateral trigone and postero-medial trigone. A holder and sizer device useful with the annuloplasty band are also provided.

Abstract: An annuloplasty band comprising a sheath, and a generally arcuate stiffening element disposed within the sheath. The stiffening element extends from a first end to a second end, and preferably includes eyelets at its first and second ends adapted to receive sutures to secure the annuloplasty band to a valve annulus. The annuloplasty band preferably has a low profile (e.g., a thickness less than 3 mm). In embodiments intended for mitral valve repair, the eyelets are particularly adapted to receive sutures to secure the annuloplasty band to the antero-lateral trigone and postero-medial trigone. A holder and sizer device useful with the annuloplasty band are also provided.

Abstract: A method of placing a valve in a tubular organ including the steps of delivering an expandable tubular adapter to a site within the tubular organ, wherein the adapter includes an enclosed volume surrounded by an outer wall that is spaced from an inner wall, and first and second end walls. The method further includes expanding the outer wall relative to the inner wall so that the outer wall contacts the tubular organ, and placing a valve within the inner wall of the adapter. The method may further include inserting material into the enclosed volume of the adapter to expand the outer wall relative to the inner wall, which material may include liquid or gel. Alternatively, the valve may be positioned within the inner wall prior to the adapter being delivered to the desired site.

Abstract: A valve system including an aortic valve and a holder. The holder includes a holder body, which has a central portion, engagable with a holder handle, and downwardly extending leg portions that engage the valve in the areas between the commissure posts. The central portion of the holder further includes a spool located between the commissure posts, rotatable by an attached handle. Rotation of the spool draws in a tensile member passing through the commissure posts, drawing the commissure posts inward toward the spool. The tensile member passes through guides formed in the holder, configured such that they define the maximum available inward deflection of the commissure posts at the point at which the portions of the tensile member between the commissure posts assume straight configurations.