Abstract: The invention provides methods, devices and systems for delivering, positioning and/or repositioning an expandable prosthetic heart valve in a patient's heart chamber. At least one non-looped wire and looped wire pair is operatively connected with an expanded prosthetic heart valve that is collapsed within a delivery catheter lumen having its distal end positioned in the subject heart chamber. The collapsed prosthetic heart valve is translated through the delivery catheter lumen to and out of its distal end where the prosthetic heart valve expands to a working configuration. The wire(s) of the non-looped and looped wire pair may be manipulated by pulling proximately or pushing distally to position or reposition the expanded prosthetic stent into position, then released from connection with the positioned stent and withdrawn from the patient.

Abstract: A device and method for predictably and controlling the collapsing of a collapsible and expandable stent for subsequent translation through a delivery sheath lumen to an anatomical target such as a heart valve or intravascular location for expansion and implantation. The loading device defines in inner lumen comprising a successively decreasing, from the proximal to the distal direction, inner diameter alternating between two sections of decreasing diameter and two sections of constant diameter until reaching the inner diameter of the delivery sheath. A fluid-filled reservoir is provided at the proximal end of the loading device that is configured to provide moisture or wetting for materials associated with or attached to the stent that require moisture retention. Thus, as the stent is being collapsed with the loading device, at least a portion of the stent may be immersed in the fluid reservoir to preserve the subject material.

Abstract: A device and method for predictably and controlling the collapsing of a collapsible and expandable stent for subsequent translation through a delivery sheath lumen to an anatomical target such as a heart valve or intravascular location for expansion and implantation. The loading device defines in inner lumen comprising a successively decreasing, from the proximal to the distal direction, inner diameter to a region of constant inner diameter wherein the stent is in a collapsed configuration. The device and method may provide for an at least partially collapsed configuration of the stent that may be further collapsed as a part of the implantation procedure and may comprise a stent that is pre-loaded for future use.

Abstract: A collapsible and expandable prosthetic heart valve stent is provided and comprising an outer section, a valve support defining a flow channel therethrough, a transition section configured to smoothly transition the outer section to the valve support. The valve support is disposed within an interior defined by the outer section, with the inflow end of the valve support disposed inside the outer section's interior. In some cases, the outflow end of the valve support is at least partially defined by the transition section. The prosthetic leaflets are disposed on the inner surface of the valve support's flow channel and are located at or above the annulus of the heart chamber. A paravalvular leakage mitigation system is attached to the stent to mitigate retrograde blood flow and/or regurgitation.

Abstract: A prosthetic heart valve may include a stent having an inflow end, an outflow end, a collapsed condition, and an expanded condition. The prosthetic valve may also include a collapsible and expandable valve assembly disposed within the stent and having a plurality of leaflets. The prosthetic valve and/or stent may include features to anchor the prosthetic valve to a native valve annulus and to seal the prosthetic valve with respect to the native valve annulus, such as planar and/or nonplanar annular sealing members coupled to ends of the stent. The stent may include one or more circumferential rows of anchor members or hooks extending radially outwardly from the stent. These hooks may be configured to extend in a particular direction when the stent is in the collapsed condition to facilitate resheathing of the stent if, upon deployment, a user determines the prosthetic heart valve is not positioned optimally.

Abstract: An expandable and collapsible stent comprising prosthetic leaflets attached to an inner valve support section that extends radially upward into an outer stent section. A transition stent section is disposed between the inner valve support section and the outer stent section. Each of the outer stent section, the inner valve support section and the transition stent section may comprise struts or the equivalent that form and define cells having a pattern, wherein each section may comprise a different cell pattern. Transition stent section preferably comprises struts that are of equal curvature, with adjacent struts equally spaced from each other to allow nested collapsing of the transition stent section struts. A boss section extending downstream away from the inner valve support section may be provided to aid in alignment and retention of the expanded stent and may comprise a shape that is complementary to a heart chamber annulus.

Abstract: The present invention comprises devices, systems and methods for providing an implanted device within a patient's atrium, wherein the implanted device comprises one or more sensors and one or more electrodes associated with the implanted device. The sensors may be used in various embodiments to monitor for arrhythmia, and in some embodiments may map the arrhythmia by detecting, inter alia, flutter and/or defibrillation, and the electrodes may be adapted to respond to any detected arrhythmia with electrostimulation including, inter alia, cardioversion and/or ablation.

Abstract: A prosthetic heart valve includes a collapsible and expandable stent extending from an inflow end to an outflow end and a plurality of prosthetic valve leaflets coupled to the stent. The prosthetic heart valve may also include a sealing ring coupled to the inflow end of the stent, the sealing ring comprising a tube extending circumferentially around the inflow end of the stent. The tube may be formed from a wire coiled into a repeating shape, such as a rectangle or a diamond, so that the tube is collapsible. A covering may at least partially surround the tube. The sealing ring may include a first filler positioned within the tube and/or a second filler positioned between the tube and the covering.

Abstract: A prosthetic heart valve for replacing a native valve includes a collapsible and expandable stent extending between a proximal end and a distal end. The stent includes an annulus section adjacent the proximal end and having a first diameter, a plurality of first struts forming cells, and a plurality of second struts connected to the annulus section and forming a plurality of deflecting cells expandable to define a second diameter larger than the first diameter. A valve assembly is disposed within the stent and a cuff is coupled to the stent and covers the plurality of deflecting cells.

Abstract: The invention relates to prosthetic heart valves comprising a stent frame with valve support disposed or inverted at least partially within the stent frame, wherein the valve support is at least partially within the interior of the stent frame. The inverted configuration comprises a maximum number of layers of material in cross section where the stent frame and valve support overlap. The maximum number of cross-sectional layers of material structure may be reduced to, e.g., two layers of material to reduce outer diameter during delivery by everting the valve portion to a position located outside of the stent portion, followed by inverted reconfiguration back to the inverted anchoring structure after delivery from the lumen of the delivery catheter to the heart chamber.

Abstract: A prosthetic heart valve for replacing a native valve includes a collapsible and expandable stent extending between a proximal end and a distal end. The stent includes an annulus section adjacent the proximal end and having a first diameter, a plurality of first struts forming cells, and a plurality of second struts connected to the annulus section and forming a plurality of deflecting cells expandable to define a second diameter larger than the first diameter. A valve assembly is disposed within the stent and a cuff is coupled to the stent and covers the plurality of deflecting cells.

Abstract: A prosthetic heart valve (300) for replacing a native heart valve includes a collapsible and expandable stent (306) extending in a length direction between a proximal end (302) and a distal end (304), the stent (306) including a plurality of struts (320) defining a plurality of cells (330), the plurality of cells (330) forming an aortic section (310), an annulus section (314) and a subannular section (316) of the stent (306). A valve assembly is disposed within the annulus section (314) of the stent (306), the valve assembly including a plurality of leaflets. In an expanded condition of the stent, each of the plurality of cells of the subannular section (316) has a width greater than its length, and each of the plurality of cells of the annulus section (314) has a length greater than its width.

Abstract: Devices and methods for supplementing and/or replacing native cardiac valve functionality, e.g., the mitral valve with a single prosthetic leaflet. An exemplary device is directed to dysfunctional mitral valves. In some cases, the entire device, including the single prosthetic leaflet, will be arranged entirely above the dysfunctional mitral valves and, therefore, disposed entirely within the left atrium. In other cases, the valve support and/or single prosthetic leaflet may extend a distance into the annulus between the left atrium and left ventricle. In some cases, the device will not physically interact with the native leaflets. In other cases, the device may physically interact with the native leaflets.

Abstract: A prosthetic heart valve includes a collapsible and expandable stent extending from an inflow end to an outflow end and a plurality of prosthetic valve leaflets coupled to the stent. The prosthetic heart valve may also include a sealing ring coupled to the inflow end of the stent, the sealing ring comprising a tube extending circumferentially around the inflow end of the stent. The tube may be formed from a wire coiled into a repeating shape, such as a rectangle or a diamond, so that the tube is collapsible. A covering may at least partially surround the tube. The sealing ring may include a first filler positioned within the tube and/or a second filler positioned between the tube and the covering.

Abstract: A prosthetic heart valve includes a collapsible and expandable stent extending from an inflow end to an outflow end and a plurality of prosthetic valve leaflets coupled to the stent. The prosthetic heart valve may also include a sealing ring coupled to the inflow end of the stent, the sealing ring comprising a tube extending circumferentially around the inflow end of the stent. The tube may be formed from a wire coiled into a repeating shape, such as a rectangle or a diamond, so that the tube is collapsible. A covering may at least partially surround the tube. The sealing ring may include a first filler positioned within the tube and/or a second filler positioned between the tube and the covering.

Abstract: Embodiments of delivery systems, devices and methods for delivering a prosthetic heart valve device to a heart chamber for expanded implementation are disclosed. More specifically, methods, systems and devices are disclosed for delivering a self-expanding prosthetic mitral valve device to the left atrium, with no engagement of the left ventricle, the native mitral valve leaflets or the annular tissue downstream of the upper annular surface during delivery, and in some embodiments with no engagement of the ventricle, mitral valve leaflets and/or annular tissue located downstream of the upper annular surface by the delivered, positioned and expanded prosthetic mitral valve device.

Abstract: A prosthetic heart valve includes a collapsible and expandable stent extending from an inflow end to an outflow end and a plurality of prosthetic valve leaflets coupled to the stent. The prosthetic heart valve may also include a sealing ring coupled to the inflow end of the stent, the sealing ring comprising a tube extending circumferentially around the inflow end of the stent. The tube may be formed from a wire coiled into a repeating shape, such as a rectangle or a diamond, so that the tube is collapsible. A covering may at least partially surround the tube. The sealing ring may include a first filler positioned within the tube and/or a second filler positioned between the tube and the covering.

Abstract: A prosthetic heart valve for replacing a native valve includes a collapsible and expandable stent having a proximal end and a distal end, the stent being formed of a plurality of struts forming cells. A valve assembly is disposed within the stent, the valve assembly including a plurality of leaflets and a cuff. At least one runner is coupled to a cell and configured to transition from a first configuration to a second configuration when the stent moves from the collapsed condition to the expanded condition.

Abstract: A prosthetic heart valve includes a collapsible and expandable stent extending from an inflow end to an outflow end and a plurality of prosthetic valve leaflets coupled to the stent. The prosthetic heart valve may also include a sealing ring coupled to the inflow end of the stent, the sealing ring comprising a tube extending circumferentially around the inflow end of the stent. The tube may be formed from a wire coiled into a repeating shape, such as a rectangle or a diamond, so that the tube is collapsible. A covering may at least partially surround the tube. The sealing ring may include a first filler positioned within the tube and/or a second filler positioned between the tube and the covering.

Abstract: A prosthetic heart valve for replacing a native valve includes a collapsible and expandable stent extending between a proximal end and a distal end. The stent includes an annulus section adjacent the proximal end and having a first diameter, a plurality of first struts forming cells, and a plurality of second struts connected to the annulus section and forming a plurality of deflecting cells expandable to define a second diameter larger than the first diameter. A valve assembly is disposed within the stent and a cuff is coupled to the stent and covers the plurality of deflecting cells.