Abstract: Various embodiments of a ventricular assist system and a method of using such system are disclosed. The system includes a pump adapted to be connected to a heart of a patient, an outflow cannula including a first end adapted to be connected to an outlet of the pump and a second end adapted to be connected to an artery of the patient, and an electrode disposed on an outer surface of the outflow cannula and adapted to be disposed adjacent to an exterior wall of the heart. The system further includes a controller electrically connected to the pump and the electrode, where the controller is adapted to provide a pacing signal to the electrode.

Abstract: A prosthetic valve may be formed to direct flow out of the outflow orifice toward a posterior portion of a heart wall. The prosthetic valve includes an expandable frame which may be covered with a cover that is suturelessly attached to the frame. The prosthetic valve may also include an outflow orifice size which is controlled. Methods of using these devices are also disclosed.

Abstract: An implantable valve prosthesis for preventing blood reflux from a cardiac atrium into a vein opening into the atrium, with a generally tubular stent (2), also a flexible tube (3) that can be closed by collapsing the tube (3) and which is arranged at least in a partial area of a second end section (9) of the stent (2) on the outer peripheral surface. The second end opening (11) of the flexible tube (3) is open in the pressureless state. As a result of this valve design, during a physiological flow out of the pulmonary vein in the direction of the left atrium or out of the caval vein in the direction of the right atrium, there is no rise or an only insubstantial rise in the resistance to flow.

Abstract: A medical implant may include an expandable anchor member having a lumen extending through the expandable anchor member from an inflow end to an outflow end; a plurality of valve leaflets disposed within the lumen extending through the expandable anchor member; a seal member disposed adjacent an exterior of the expandable anchor member; and a porous material extending from the seal member to the plurality of valve leaflets.

Abstract: Support frames and medical devices are described. An example medical device comprises an expandable support frame with first and second leaflets attached to the support frame. Each of the first and second leaflets defines a domed radius that is equal to or less than the radius of the expandable support frame when the expandable support frame is in an expanded configuration and the leaflets are subjected to fluid pressure sufficient to affect closure of the valve orifice.

Abstract: A medical device including a valve member with an elongate tubular portion with at least one aperture disposed in a sidewall at a location between the proximal and distal ends, and a plurality of leaflets; a first endovascular graft coupled to the valve member; and a second endovascular graft coupled to the first endovascular graft; and an expandable anchor member coupled to the second endovascular graft.

Abstract: Prosthetic valves are provided with a leaflet assembly having at least one leaflet attached to a supporting element, which leaflet has a free margin that can move between a first position wherein the free margin is flexed away from a closure surface to allow body fluid to flow through the valve, and a second position wherein the free margin abuts the closure surface to close the valve, and wherein the leaflet, without pulsatile load on the valve, can form a coaptation height H of more than 0.1 mm along the length of the free margin. Such prosthetic valve provides good performance during prolonged time, and can be made using various materials for the leaflets.

Abstract: This invention relates to the design and function of a retrieval device for a prosthetic heart valve for re-positioning or removal of a previously implanted valve prosthesis from a beating heart without extracorporeal circulation using a transcatheter retrieval system.

Abstract: A prosthetic mitral valve may be anchored in a native mitral valve. The prosthetic mitral valve preferably has a large anterior prosthetic leaflet that spans the entire width of the native anterior leaflet and the anterior prosthetic leaflet moves away from left ventricular outflow tract during systole to create a clear unobstructed outflow path.

Abstract: The present technology relates to aneurysm devices with additional anchoring mechanisms, and associated systems and methods. The aneurysm device is endovascularly deliverable to a site proximate an aneurysm near a parent artery with bifurcating branches. The device can include a closure structure comprising a distal-facing aspect configured to at least partially occlude the aneurysm. The closure structure can be formed from a generally flat pattern and is transformable between a compressed configuration and a deployed configuration. The device can also have one or more lodging elements which fold to form loop elements configured for anchoring within at least one of the bifurcating branches. The struts of the lodging elements can include hinge points which bias the folding of the lodging elements. The devices further include a supplemental stabilizer connected to the closure structure and configured to reside in the parent artery.

Abstract: Devices and methods for treating heart disease by increasing the pulmonary vascular compliance and thereby decreasing the right ventricular afterload are disclosed. Devices may include a means for reducing the cross-sectional area of the pulmonary artery during diastole and allowing the cross-sectional area to increase during systole.

Abstract: A prosthetic valve for implantation within a native mitral valve may be provided. The prosthetic valve may include an annular valve body, a plurality of atrial anchoring arms configured to extend radially outward from the annular valve body, and a plurality of ventricular anchoring legs configured to extend radially outward from the annular valve body. The arms may be configured to engage an atrial portion of the native mitral valve and the ventricular anchoring legs may be configured to engage a ventricular portion of the native mitral valve. The atrial anchoring arms and the ventricular anchoring legs may be positioned relative to each other such that when the atrial anchoring arms and ventricular anchoring legs engage the native mitral valve, a volume between the atrial anchoring arms and ventricular anchoring legs is configured to be substantially filled with tissue.

Abstract: Devices and methods for treating tricuspid regurgitation (TR) are provided. A clasp or clamp is used to anchor a TR-treatment device to an existing lead of a pacemaker or an implantable cardioverter defibrillator (ICD) that passes through the tricuspid valve. The TR-treatment device can be a balloon occluder that is adjustable by filling or withdrawing filler material from the occluder through a proximal port implanted in the skin of the patient.

Abstract: A two-stage or component-based valve prosthesis that can be quickly and easily implanted during a surgical procedure is provided. The prosthetic valve comprises a support structure that is deployed at a treatment site. The prosthetic valve further comprises a valve member configured to be quickly connected to the support structure. The support structure may take the form of a stent that is expanded at the site of a native valve. If desired, the native leaflets may remain and the stent may be used to hold the native valve open. In this case, the stent may be balloon expandable and configured to resist the powerful recoil force of the native leaflets. The support structure is provided with a coupling means for attachment to the valve member, thereby fixing the position of the valve member in the body. The valve member may be a non-expandable type, or may be expandable from a compressed state to an expanded state.

Abstract: A prosthetic heart valve includes a frame, a valvular structure coupled to the frame, and a sealing member coupled to the frame. The frame has inflow and outflow ends and a lumen extending therebetween. The frame includes struts that form cells, and the cells are arranged in three rows. The frame is radially expandable from a collapsed state to an expanded state. The valvular structure includes a plurality of leaflets configured to allow blood flow through the lumen of the frame from the inflow end to the outflow end and to block blood flow through the lumen of the frame from the outflow end to the inflow end. The sealing skirt extends from an intermediate location of the frame disposed between the inflow and outflow ends to the inflow end of the frame. The sealing skirt covers two rows of cells to block blood flow through the cells.

Abstract: The present invention provides an apparatus for endovascularly replacing a patient's heart valve. In some embodiments, the apparatus includes an expandable anchor supporting a replacement valve, the anchor and replacement valve being adapted for percutaneous delivery and deployment to replace the patient's heart valve, the anchor having a braid having atraumatic grasping elements adapted to grasp tissue in a vicinity of the patient's heart valve.

Abstract: The present invention provides devices for treating functional mitral regurgitation and methods of use thereof. The devices translocate a subject's mitral valve in an apical direction. The devices thereby treat mitral regurgitation while preserving a subject's original mitral valve and chordae tendinae.

Abstract: A frame for an implantable medical device, comprising: a first member, comprising a plurality of struts defining a plurality of cells, wherein the first member is annular and defines a longitudinal direction which is parallel to the axis of the first member, a radial direction, and a circumferential direction; a second member, comprising a plurality of struts and coupled to the first member at circumferentially distributed locations; wherein the second member overlaps a first end portion of the first member and extends beyond the first end portion of the first member.

Abstract: A frame assembly (222) includes a tubular portion (32) that defines a lumen along an axis; a plurality of arms (46) coupled to the tubular portion at a first axial level, each of the arms extending radially outward from the tubular portion to a respective arm-tip; and a plurality of ventricular legs (50) that are coupled to the tubular portion at a second axial level, and that extend radially outward from the tubular portion. A first sheet (440) has a greater perimeter (446), and a smaller perimeter (448) that defines an opening. The first sheet is stitched onto the plurality of arms, with the opening aligned with the lumen. Subsequently, an outer perimeter (454) of a second sheet (450) is stitched to the greater perimeter of the first sheet. Subsequently, the second sheet is everted by passing an inner perimeter (452) of the second sheet around the arm-tips.

Abstract: A replacement heart valve system may include a delivery sheath and a replacement heart valve. The replacement heart valve may include a mesh anchor member disposed within the delivery sheath in an elongated delivery configuration, the mesh anchor member being expandable to a deployed configuration when unconstrained by the delivery sheath. The mesh anchor member may include an upstream chamber, a downstream chamber, and a tubular middle portion extending between the upstream chamber and the downstream chamber. The replacement heart valve may include a diaphragm disposed within the downstream chamber of the mesh anchor member, wherein the diaphragm is configured to selectively prevent fluid flow through the replacement heart valve.

Abstract: An embolic material blocking catheter includes a handle assembly, an elongated element having a lumen, and a deployable embolic material blocking element. The embolic material blocking catheter is configured to accommodate insertion of a treatment catheter into the lumen to position a treatment device distal to the embolic material blocking element for administering a treatment at a treatment site and/or convey embolic material blocked by the embolic material blocking element for extraction from the patient.

Abstract: This invention relates to the design and function of a compressible valve replacement prosthesis which can be deployed into a beating heart without extracorporeal circulation using a transcatheter delivery system. The design as discussed focuses on the deployment of a device via a minimally invasive fashion and by way of example considers a minimally invasive surgical procedure preferably utilizing the intercostal or subxyphoid space for valve introduction. In order to accomplish this, the valve is formed in such a manner that it can be compressed to fit within a delivery system and secondarily ejected from the delivery system into the annulus of a target valve such as a mitral valve or tricuspid valve.

Abstract: A prosthetic valve comprising a conical shaped ribbon structure comprising an extracellular matrix (ECM) composition. The ribbon structure comprises a plurality of elongated ribbon members that are positioned proximate each other in a joined relationship, wherein the ribbon members are positioned adjacent each other and form a plurality of fluid flow modulating regions that open when fluid flow through the valve exhibits a negative flow pressure and open when fluid flow through the valve exhibits a positive flow pressure.

Abstract: A prosthetic valve comprising a conical shaped ribbon structure comprising a polymeric composition. The ribbon structure comprises a plurality of elongated ribbon members that are positioned proximate each other in a joined relationship, wherein the ribbon members are positioned adjacent each other and form a plurality of fluid flow modulating regions that open when fluid flow through the valve exhibits a negative flow pressure and open when fluid flow through the valve exhibits a positive flow pressure.

Abstract: A method of treating a defective heart valve includes inserting a delivery catheter through a small incision in a patient's groin, wherein the delivery catheter has a prosthetic device positioned along a distal end. The prosthetic device includes an insert member and an anchoring member. The insert member is positioned between the native heart valve and is allowed to self-expand. The anchoring member is preferably a stent connected to the insert member by at least one elongate member. The stent is deployed within an adjacent blood vessel for anchoring the insert member between the native leaflets. After deployment of the prosthetic device, the native leaflets of the heart valve form a tight seal against the insert member for preventing regurgitation through the native heart valve during ventricular systole.

Abstract: A mitral valve prosthesis includes an hourglass shaped inner frame and a bulbous outer frame. A valve body having a plurality of leaflets is positioned within an interior region of the inner frame. The leaflets are shaped to substantially conform to an interior surface of the inner frame when the leaflets are in an open position. As a result, the gap between the leaflets and the inner frame is decreased, thereby reducing the likelihood of thrombus formation. Ventricular anchors are preferably provided along a distal end of the inner frame. The anchors extend proximally for placement behind native mitral valve leaflets. A fabric skirt may extend along an inner or outer surface of the outer frame. In preferred embodiments, the fabric skirt extends distally beyond a distal end of the outer frame and is adapted for forming a seal along the mitral valve annulus.

Abstract: An implantable endoluminal prosthesis for replacing a damaged aortic valve is provided. In one embodiment, the prosthesis includes a balloon-expandable stent, a tubular conduit that extends into the ascending aorta, and a self-expanding stent. The tubular conduit extends across the balloon-expandable stent. The tubular conduit includes an artificial valve. The self-expanding stent extends across the tubular conduit into the ascending aorta. The balloon-expandable stent, the tubular conduit, and the self-expanding stent are coupled to provide unidirectional flow of fluid into the aorta and further into the coronary arteries. Also provided is a method for implanting the endoluminal prosthesis.

Abstract: A prosthetic heart valve includes a frame, a valvular structure coupled to the frame, and a sealing member coupled to the frame. The frame has inflow and outflow ends and a lumen extending therebetween. The frame includes struts that form cells, and the cells are arranged in three rows. The frame is radially expandable from a collapsed state to an expanded state. The valvular structure includes a plurality of leaflets configured to allow blood flow through the lumen of the frame from the inflow end to the outflow end and to block blood flow through the lumen of the frame from the outflow end to the inflow end. The sealing skirt extends from an intermediate location of the frame disposed between the inflow and outflow ends to the inflow end of the frame. The sealing skirt covers two rows of cells to block blood flow through the cells.

Abstract: A prosthetic vascular valve includes one or more continuous loops of frame material or one or more strands of material that do not form a continuous loop. The frame includes a plurality of longitudinal portions, wherein a membrane is attached to at least one of the longitudinal portions, and wherein the membrane is configured to open and close. During implantation, the frame engages the inner surface of the vein wall and is biased against the vein wall to remain stationary. In use, blood flows from an upstream end to a downstream end, wherein the membrane mitigates regurgitation of the blood as the blood is conveyed through the subject vein.

Abstract: A venous valve prosthesis includes a frame and a prosthetic valve coupled to the frame. With the venous valve prosthesis implanted in a vein, the prosthetic valve includes a closed configuration wherein an outer surface of the prosthetic valve is in contact with a wall of the vein around a circumference of the prosthetic valve to prevent blood from flowing past the prosthetic valve between the wall of the vein and the outer surface of the prosthetic valve. The prosthetic valve is configured to move to an open configuration such that at least a portion of an outer wall of the prosthetic valve partially collapses away from the wall of the vein in response to antegrade blood flow through the vein to enable blood flow between the outer surface of the prosthetic valve and the wall of the vein.

Abstract: A prosthetic heart valve includes a collapsible and expandable annular frame. The frame includes a plurality of rows of hexagonal cells. Each of the hexagonal cells is defined by six struts, including: two opposing side struts extending parallel to each other, a first pair of angled struts extending from respective first ends of the side struts and converging to intersect with each other, and a second pair of angled struts extending from respective second ends of the side struts and converging to intersect with each other. The prosthetic heart valve can also include a valvular structure with a plurality of leaflets. The prosthetic heart valve can further include a sealing member.

Abstract: A replacement heart valve device is disclosed. In some embodiments, the device includes a frame coupled to one or more leaflets that are moveable between open and closed configurations. In some embodiments, the frame comprises at least two frame sections that join at a pair of commissural posts. In some embodiments, the device may be geometrically accommodating to adapt to different vasculature shapes and sizes and/or to be able to change size while implanted within a growing patient.

Abstract: A prosthetic valve comprising a conical shaped ribbon structure comprising an extracellular matrix (ECM) composition. The ribbon structure comprises a plurality of elongated ribbon members that are positioned proximate each other in a joined relationship, wherein the ribbon members are positioned adjacent each other and form a plurality of fluid flow modulating regions that open when fluid flow through the valve exhibits a negative flow pressure and open when fluid flow through the valve exhibits a positive flow pressure.

Abstract: Venous endoluminal devices, in particular for the treatment of defects of the veins, are provided with a substantially tubular body which defines an inner lumen and support modules oriented longitudinally and joined, in a distal direction, by distal bridges and in a proximal direction, by proximal bridges. Each support module includes a distal section, extending in a distal direction beyond the distal bridges, wherein the distal section is at least partially projecting in a radial direction, internally in relation to the inner lumen of the body. Methods of treatment using such devices are also provided.

Abstract: The invention relates to a radially expandable stent (1) comprising a plurality of flexibly interconnected meandering ring elements (2, 3) defining a stent (1) having a proximal and a distal end and a longitudinal axis, wherein said ring elements (2, 3) being arranged side by side along the longitudinal axis of the stent and adjoining ring elements (2, 3) being attached to each other through connection elements (4), wherein connection elements (4) are arranged between at least two adjoining ring elements (2, 3), said connection elements each having at least one expandable expansion element with predetermined breaking point (10), wherein the expansion being possible in the longitudinal and/or transverse direction and the predetermined breaking points (10) only disrupting after the expansion element has been overstretched beyond its maximum expansion point.

Abstract: An example medical device is disclosed. An example medical device includes an expandable stent. The stent includes a tubular scaffold formed of one or more interwoven filament. The tubular scaffold includes an inner surface and a flexible valve extending radially inward from the inner surface of the scaffold. Further, the valve is configured to shift between a closed configuration and an open configuration and the one or more filaments of the scaffold bias the valve to the closed configuration while in a nominally deployed state.

Abstract: In an aspect, a device includes a body structure including a core and a sleeve disposed around at least a portion of the core, the core defining a channel through the core extending from a first end of the core to a second end of the core, the sleeve including a flange adjacent the second end of the core; and a deployable portion coupled to the body structure adjacent the first end of the core, the deployable portion having a wired structure transitionable between a retained configuration and a deployed configuration, wherein a top portion of the wired structure extends beyond the first end of the core in a longitudinal direction when the wired structure is in the retained configuration, and wherein first end of the core extends beyond the top portion of the wired structure when the wired structure is in the deployed configuration.

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

Abstract: A prosthetic heart valve having an inflow end and an outflow end includes a collapsible and expandable stent having a plurality of commissure features, a plurality of first struts and a plurality of second struts. The plurality of first struts define a substantially cylindrical portion and the plurality of second struts have first ends attached to the cylindrical portion and free ends projecting radially outward from the cylindrical portion and configured to couple to adjacent heart tissue to anchor the stent. A collapsible and expandable valve assembly disposed within the stent has a plurality of leaflets coupled to the commissure features.

Abstract: Prosthetic valves and methods of use of prosthetic valves may be provided. In one implementation, a method of releasing a prosthetic valve from a delivery capsule within a heart may be provided. The delivery capsule may include a distal capsule portion and a proximal capsule portion. The method may include moving the distal capsule portion in a first direction to release ventricular anchoring legs of the prosthetic valve from the delivery capsule and moving the released legs into contact with a native mitral valve. The method may include moving the proximal capsule portion in a second direction to release atrial anchoring arms of the prosthetic valve from the delivery capsule, after contacting the mitral valve with the released legs. The method may include moving the distal capsule portion in the first direction to release an annular valve body of the prosthetic valve from the delivery capsule.

Abstract: A collapsible and expandable stent body includes a generally tubular annulus section, one or more prosthetic valve elements mounted to the stent body, and a cuff attached to the stent body. The prosthetic valve is operative to allow flow in an antegrade direction but to substantially block flow in a retrograde direction. The prosthetic heart valve may include paravalvular leak mitigation features in the form of first and second sealing members. The sealing members are attached to the cuff and extend circumferentially around an abluminal surface of the stent body. The sealing members each have an open side facing in a first axial direction and a closed side facing in an opposite second axial direction. Flow of blood in the second axial direction will tend to force blood into the sealing members and cause the sealing members to billow outwardly relative to the stent body, helping to mitigate paravalvular leak.

Abstract: The stent graft (10) comprises a cylinder comprising a graft material in the form of a film and a stent that supports the cylinder. Further, the stent graft (10) is inserted within a region from the ascending aorta to the sinus of valsalva, and the stent graft comprises cylindrical body section (11) arranged in the ascending aorta and the sinus of valsalva section (12) arranged in the sinus of valsalva and having an inner diameter larger than that of the body section (11).

Abstract: This disclosure relates to a valve assembly for a motor vehicle, such as a pressure relief valve, and a method of using the same. The valve assembly includes a flap moveable to between an open position and a closed position. The valve assembly further includes a pair of shape memory-alloy (SMA) wires configured to move the flap between the open and closed positions. Specifically, the valve includes a first shape-memory alloy wire configured to rebound to a first rebound shape to urge the flap to the open position, and a second shape-memory alloy wire configured to rebound to a second rebound shape to urge the flap to the closed position.

Abstract: The invention relates to a prosthetic valve (1) for regulating fluid flow between an upstream side (4) and a downstream side (5) and being operable between an open status and a closed status. The prosthetic valve comprises: —an orifice (2) arranged in a surrounding member (3) and extending between the upstream side (4) and the downstream side (5) wherein in the open status of the prosthetic valve (1) the fluid flow through the orifice is maximally enabled and wherein in the closed status of the prosthetic valve the fluid flow through the orifice in a restriction direction (21) from the downstream side (5) to the upstream side (4) is restricted; and—a leaflet (6) arranged in the orifice and being operable between an open status corresponding to the open status of the prosthetic valve and a closed status corresponding to the closed status of the prosthetic valve.

Abstract: A method of treating a mitral valve without open-heart surgery is disclosed. An expandable prosthesis comprises an anchoring portion and an occluding member coupled to the anchoring portion. The prosthesis is loaded into a distal end of a delivery catheter and advanced through a femoral vein and through a pre-made puncture in an atrial septum. The occluding member is then positioned in the mitral valve and the anchoring portion is positioned in the left atrium for maintaining the occluding member between the leaflets of the mitral valve. After deployment, the occluding member prevents blood from flowing from the left ventricle to the left atrium during systole.

Abstract: A prosthetic heart valve can include an expandable support stent, a valve assembly, and a connecting membrane. The support stent can have first and second end portions and can be configured to be radially expandable from a first configuration to a second configuration. The valve assembly can have an inlet portion, an outlet portion, and a plurality of leaflets, and the valve assembly can be supported in the support stent. The connecting membrane can be disposed radially between the support stent and the valve assembly, wherein the support stent and the valve assembly can be connected to the connecting membrane.

Abstract: A stented valve including a stent structure including a generally tubular body portion having a first end, a second end, an interior area, a longitudinal axis, and a plurality of vertical wires extending generally parallel to the longitudinal axis around a periphery of the body portion, wherein the plurality of vertical wires includes multiple commissure wires and at least one structural wire positioned between adjacent commissure wires, and a plurality of V-shaped wire structures having a first end, a second end, and a peak between the first and second ends, wherein a first end of each V-shaped structure extends from a first vertical wire and a second end of each V-shaped structure extends from a second vertical wire that is adjacent to the first vertical wire, wherein each V-shaped structure is oriented so that its peak is facing in the same direction relative to the first and second ends of the body portion, and a valve structure including a plurality of leaflets attached to the stent structure within the

Abstract: A prosthetic valve coaptation assist device (100) includes an anchor (101) and a single valve assist leaflet (102). The anchor may be a supporting ring frame, brace or arc structure and will usually be radially self-expandable so that it can expand against surrounding tissue. The valve assist leaflet may be made of pericardium or other biological or artificial material and is shaped like the native target valve leaflet. The valve assist leaflet is typically sized larger than the target leaflet so that after implantation a significant overlap of the device body occurs.

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 tapered edge.

Abstract: Stented prosthetic heart valves including a stent frame having a plurality of stent frame support structures collectively defining an interior surface, an exterior surface and a plurality of cells. The stented prosthetic heart valve further including a valve structure including valve leaflets disposed within and secured to the stent frame and defining a margin of attachment. The stented prosthetic heart valve including one or both of an outer paravalvular leakage prevention wrap and an inner skirt for supporting the valve leaflets. In various embodiments, the outer wrap is positioned entirely on one side of the margin of attachment. In embodiments including an inner skirt, the outer wrap and the inner skirt are on opposite sides of the margin of attachment such that the inner skirt and the outer wrap do not overlap. In other embodiments, the outer wrap includes a plurality of zones having varying thickness.