Abstract: A delivery device is configured for aligning and stabilizing a prosthetic heart valve for deployment in a native heart valve annulus. The device includes a catheter assembly having an inner shaft around which a valve compartment is defined, an outer shaft assembled over the inner shaft and adapted to slide relative to the inner shaft, a distal sheath connected to a distal end of the outer shaft and slidable therewith, an outer tube assembled over the outer shaft, and an alignment and stabilization device having a collapsed condition and an expanded condition. The outer tube is adapted to slide relative to the outer shaft to selectively cover and uncover the alignment and stabilization device.

Abstract: A medical device for treating an atrial septal defect (ASD) includes a first occluding member, and a second occluding member disposed in opposition to the first occluding member. The medical device also includes at least one elongate shaft extending through and between the first occluding member and the second occluding member. The first occluding member is foldable to expand and contract relative to the second occluding member. The second occluding member is foldable to expand and contract relative to the first occluding member. In operation, at least one of the first occluding member and the second occluding member is configured to expand relative to the other of the first occluding member and the second occluding member to treat the ASD at the target site.

Abstract: A method of delivering a prosthetic mitral valve includes delivering a distal anchor from a delivery sheath such that the distal anchor self-expands inside a first heart chamber on a first side of the mitral valve annulus, pulling proximally on the distal anchor such that the distal anchor self-aligns within the mitral valve annulus and the distal anchor rests against tissue of the ventricular heart chamber, and delivering a proximal anchor from the delivery sheath to a second heart chamber on a second side of the mitral valve annulus such that the proximal anchor self-expands and moves towards the distal anchor to rest against tissue of the second heart chamber. The self-expansion of the proximal anchor captures tissue of the mitral valve annulus therebetween.

Abstract: A ventricular partitioning device for isolating damaged tissue within a ventricle of the heart is disclosed. The ventricular partitioning device includes a disk-shaped portion configured to isolate a portion of a ventricular wall to facilitate remodeling of the ventricular wall. The device further includes an anchor configured to secure the device to the ventricular wall.

Abstract: A method of delivering a prosthetic mitral valve includes delivering a distal anchor from a delivery sheath such that the distal anchor self-expands inside a first heart chamber on a first side of the mitral valve annulus, pulling proximally on the distal anchor such that the distal anchor self-aligns within the mitral valve annulus and the distal anchor rests against tissue of the ventricular heart chamber, and delivering a proximal anchor from the delivery sheath to a second heart chamber on a second side of the mitral valve annulus such that the proximal anchor self-expands and moves towards the distal anchor to rest against tissue of the second heart chamber. The self-expansion of the proximal anchor captures tissue of the mitral valve annulus therebetween.

Abstract: A prosthetic heart valve includes a collapsible stent and a valve assembly disposed within the stent. A first cuff is disposed adjacent the stent. A second cuff having a distal edge facing the outflow end of the stent is disposed about the stent radially outward of the first cuff and the stent. The stent may include a plurality of fingers each having a first end coupled to a corresponding cell of the stent and a free end adapted to extend radially outward of the corresponding cell. The distal edge of the second cuff may be coupled to the fingers at spaced locations around the circumference of the stent to position the distal edge radially outward from the corresponding cells at the spaced locations. Various stent struts may be tapered to reduce the stent circumference in the collapsed condition, and to improve the fatigue resistance and/or bendability of the stent.

Abstract: A prosthetic heart valve may include a collapsible and expandable stent, a cuff attached to an annulus section of the stent, and a plurality of leaflets attached to at least one of the cuff or the stent within an interior region of the stent. The stent may have a plurality of cells connected to one another in a plurality of annular rows around the stent. The leaflets together may have a coapted position occluding the interior region of the stent and an open position in which the interior region is not occluded. Each leaflet may include a flat mesh of braided wire material having a plurality of pores extending therethrough. The leaflets may be devoid of biological material at a time of implantation.

Abstract: A prosthetic heart valve includes a collapsible stent and a valve assembly disposed within the stent. A first cuff is disposed adjacent the stent. A second cuff having a distal edge facing the outflow end of the stent is disposed about the stent radially outward of the first cuff and the stent. The stent may include a plurality of fingers each having a first end coupled to a corresponding cell of the stent and a free end adapted to extend radially outward of the corresponding cell. The distal edge of the second cuff may be coupled to the fingers at spaced locations around the circumference of the stent to position the distal edge radially outward from the corresponding cells at the spaced locations. Various stent struts may be tapered to reduce the stent circumference in the collapsed condition, and to improve the fatigue resistance and/or bendability of the stent.

Abstract: Disclosed herein is an inflow cannula for an implantable blood pump assembly. The inflow cannula includes a tubular body that extends from a proximal end to a distal end. The tubular body includes a proximal portion adapted for connection to a pump housing, and a distal portion adapted for positioning within an opening formed in a heart. The inflow cannula further includes an expandable sleeve coupled to an exterior surface of the distal portion. The sleeve has a first portion coupled to the distal portion of the tubular body, and a second portion extending from the distal end of the tubular body. The second portion is deployable from a first, stored configuration to a second, deployed configuration in which the second portion expands radially to engage and conform to an endocardial surface of the heart.

Abstract: A prosthetic heart valve may include a collapsible and expandable stent, a cuff attached to an annulus section of the stent, and a plurality of leaflets attached to at least one of the cuff or the stent within an interior region of the stent. The stent may have a plurality of cells connected to one another in a plurality of annular rows around the stent. The leaflets together may have a coapted position occluding the interior region of the stent and an open position in which the interior region is not occluded. Each leaflet may include a flat mesh of braided wire material having a plurality of pores extending therethrough. The leaflets may be devoid of biological material at a time of implantation.

Abstract: A delivery device is configured for aligning and stabilizing a prosthetic heart valve for deployment in a native heart valve annulus. The device includes a catheter assembly having an inner shaft around which a valve compartment is defined, an outer shaft assembled over the inner shaft and adapted to slide relative to the inner shaft, a distal sheath connected to a distal end of the outer shaft and slidable therewith, an outer tube assembled over the outer shaft, and an alignment and stabilization device having a collapsed condition and an expanded condition. The outer tube is adapted to slide relative to the outer shaft to selectively cover and uncover the alignment and stabilization device.

Abstract: Prosthetic mitral valves and their methods of manufacture and use.

Abstract: Combined embolic protection devices and prosthetic heart valve delivery devices useful for filtering emboli during a heart valve replacement procedure are described. The delivery devices may include a delivery sheath for housing the prosthetic heart valve in collapsed condition for delivery. The delivery devices may include one or more embolic protection filters received within the delivery device during the delivery of the prosthetic heart valve. The embolic protection filters may be deployed into an expanded or deployed condition prior to deploying the prosthetic heart valve. Any embolic debris entering the bloodstream during the prosthetic heart valve deployment may be trapped within, or deflected by, the deployed embolic filter(s) to reduce the risk of stroke.

Abstract: Disclosed herein is an inflow cannula for an implantable blood pump assembly. The inflow cannula includes a tubular body that extends from a proximal end to a distal end. The tubular body includes a proximal portion adapted for connection to a pump housing, and a distal portion adapted for positioning within an opening formed in a heart. The inflow cannula further includes an expandable sleeve coupled to an exterior surface of the distal portion. The sleeve has a first portion coupled to the distal portion of the tubular body, and a second portion extending from the distal end of the tubular body. The second portion is deployable from a first, stored configuration to a second, deployed configuration in which the second portion expands radially to engage and conform to an endocardial surface of the heart.

Abstract: A method of delivering a prosthetic mitral valve includes delivering a distal anchor from a delivery sheath such that the distal anchor self-expands inside a first heart chamber on a first side of the mitral valve annulus, pulling proximally on the distal anchor such that the distal anchor self-aligns within the mitral valve annulus and the distal anchor rests against tissue of the ventricular heart chamber, and delivering a proximal anchor from the delivery sheath to a second heart chamber on a second side of the mitral valve annulus such that the proximal anchor self-expands and moves towards the distal anchor to rest against tissue of the second heart chamber. The self-expansion of the proximal anchor captures tissue of the mitral valve annulus therebetween.

Abstract: A method of delivering a prosthetic mitral valve includes delivering a distal anchor from a delivery sheath such that the distal anchor self-expands inside a first heart chamber on a first side of the mitral valve annulus, pulling proximally on the distal anchor such that the distal anchor self-aligns within the mitral valve annulus and the distal anchor rests against tissue of the ventricular heart chamber, and delivering a proximal anchor from the delivery sheath to a second heart chamber on a second side of the mitral valve annulus such that the proximal anchor self-expands and moves towards the distal anchor to rest against tissue of the second heart chamber. The self-expansion of the proximal anchor captures tissue of the mitral valve annulus therebetween.

Abstract: A prosthetic heart valve includes a collapsible stent and a valve assembly disposed within the stent. A first cuff is disposed adjacent the stent. A second cuff having a distal edge facing the outflow end of the stent is disposed about the stent radially outward of the first cuff and the stent. The stent may include a plurality of fingers each having a first end coupled to a corresponding cell of the stent and a free end adapted to extend radially outward of the corresponding cell. The distal edge of the second cuff may be coupled to the fingers at spaced locations around the circumference of the stent to position the distal edge radially outward from the corresponding cells at the spaced locations. Various stent struts may be tapered to reduce the stent circumference in the collapsed condition, and to improve the fatigue resistance and/or bendability of the stent.

Abstract: A prosthetic heart valve includes a collapsible stent and a valve assembly disposed within the stent. A first cuff is disposed adjacent the stent. A second cuff having a distal edge facing the outflow end of the stent is disposed about the stent radially outward of the first cuff and the stent. The stent may include a plurality of fingers each having a first end coupled to a corresponding cell of the stent and a free end adapted to extend radially outward of the corresponding cell. The distal edge of the second cuff may be coupled to the fingers at spaced locations around the circumference of the stent to position the distal edge radially outward from the corresponding cells at the spaced locations. Various stent struts may be tapered to reduce the stent circumference in the collapsed condition, and to improve the fatigue resistance and/or bendability of the stent.