Abstract: An introducer sheath includes an elongate shaft having a proximal end, a distal end and a lumen extending therebetween. An actuatable hemostasis valve in a hub is adjacent the proximal end of the elongate shaft and may be used to prevent blood from escaping from the elongate shaft. The introducer sheath may also have a a self-expanding funnel adjacent the distal end of the elongate shaft.

Abstract: A prosthetic valve may be used to repair a diseased or otherwise damaged heart valve such as the mitral valve. The prosthetic valve may include atraumatic anchor tabs which may be radiopaque or echogenic. A cinching mechanism may also be coupled to the prosthetic valve to control radial expansion of the prosthetic valve. The cinching mechanism may include a wire lasso or a belt. The prosthetic valve may include an expandable frame which has a reduced number of strut connection nodes to allow a lower profile collapsed configuration and tighter crimping. The commissure posts of the prosthetic valve may extend beyond an edge of the ventricular skirt portion of the device.

Abstract: A prosthesis delivery catheter has an inner distal capsule shaft and a distal capsule configured to house the prosthesis. An anchor catheter with an anchor hub is slidably disposed over the inner distal capsule shaft. An elbow catheter is slidably disposed over the anchor catheter, and a peg plate assembly is adjacent the anchor hub. The peg plate assembly has a plurality of protruding pegs and a plate which form a closed configuration with the pegs abutting the plate, and an open configuration where a gap is between the pegs and plate allowing release of a tether.

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: A prosthetic valve may be used to repair a diseased or otherwise damaged heart valve such as the mitral valve. The prosthetic valve may include atraumatic anchor tabs which may be radiopaque or echogenic. A cinching mechanism may also be coupled to the prosthetic valve to control radial expansion of the prosthetic valve. The cinching mechanism may include a wire lasso or a belt. The prosthetic valve may include an expandable frame which has a reduced number of strut connection nodes to allow a lower profile collapsed configuration and tighter crimping. The commissure posts of the prosthetic valve may extend beyond an edge of the ventricular skirt portion of the device.

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: A prosthetic heart valve includes a stent having an expanded condition and a collapsed condition. The stent includes a plurality of distal cells, a plurality of proximal cells, a plurality of support struts coupling the proximal cells to the distal cells, and at least one support post connected to a plurality of proximal cells. The proximal cells are longitudinally spaced apart from the distal cells. Various strut configurations and connections of the struts to the proximal cells and of the proximal cells to the support post improve stent flexibility and reduce stress in the valve leaflets.

Abstract: An introducer sheath includes an elongate shaft having a proximal end, a distal end and a lumen extending therebetween. An actuatable hemostasis valve in a hub is adjacent the proximal end of the elongate shaft and may be used to prevent blood from escaping from the elongate shaft. The introducer sheath may also have a a self-expanding funnel adjacent the distal end of the elongate shaft.

Abstract: A prosthetic heart valve having an inflow end and an outflow end includes a collapsible and expandable stent, a collapsible and expandable valve assembly disposed within the stent and having a plurality of leaflets, and a deformable frame having a first end and a second end. The frame includes braided wires forming a body having a lumen extending therethrough for receiving the stent and the valve assembly, the body having a plurality of diameters from the first end to the second end.

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: A prosthetic valve may be used to repair a diseased or otherwise damaged heart valve such as the mitral valve. The prosthetic valve may include atraumatic anchor tabs which may be radiopaque or echogenic. A cinching mechanism may also be coupled to the prosthetic valve to control radial expansion of the prosthetic valve. The cinching mechanism may include a wire lasso or a belt. The prosthetic valve may include an expandable frame which has a reduced number of strut connection nodes to allow a lower profile collapsed configuration and tighter crimping. The commissure posts of the prosthetic valve may extend beyond an edge of the ventricular skirt portion of the device.

Abstract: An introducer provides access to a surgical site in a patient. The introducer includes a proximal housing configured to be positioned outside the patient and a sheath extending from the proximal housing to a distal end of the introducer. One or more handles may be housed at least partially within the proximal housing and configured to translate axially in proximal and distal directions with respect to the proximal housing. A securing element may be slideably coupled to the sheath and may have a flange extending radially outwardly from the sheath. A radially expanding portion of the sheath may have a first edge, a second edge, and a middle section extending from the first edge to the second edge. The sheath portion may have a rolled configuration in which the middle section at least partially overlies the first edge, and the second edge at least partially overlies the middle section.

Abstract: A method of preparing a tissue swatch comprising one or more desired thicknesses for use in the manufacture of a bioprosthetic device, the method comprising sectioning a sheet of frozen tissue to produce a tissue swatch of the one or more desired thicknesses.

Abstract: A delivery device for a collapsible medical device may include a handle and a delivery assembly having a compartment for receiving the medical device. A catheter member may extend from the handle to the delivery assembly. The catheter member may have a first portion with a first compliance value and a second portion with a second compliance value different from the first compliance value. An internally threaded member may be fixedly connected to the delivery assembly. An externally threaded member may have a first portion operatively connected to the actuation member and a second portion threadedly coupled to the internally threaded member so that manipulation of the actuation member causes axial movement of the compartment relative to the catheter member.

Abstract: A device for repositioning an implant within a lumen of a subject including (a) a catheter having forward and rearward ends and a collapsible and expansible stop element mounted adjacent the forward end of the catheter, the stop element being adapted to engage a wall of the lumen when expanded and to provide one or more passages extending from a rear side of the stop element to a forward side of the stop element when the stop element is expanded and engaged with the wall of the lumen and (b) one or more snares, each snare having engagement features, the stop element and the snares being constructed and arranged so that the snares can be positioned extending through the one or more passages with their engagement features forward of the stop element.

Abstract: A prosthetic heart valve includes a stent having an expanded condition and a collapsed condition. The stent includes a plurality of distal cells, a plurality of proximal cells, a plurality of support struts coupling the proximal cells to the distal cells, and at least one support post connected to a plurality of proximal cells. The proximal cells are longitudinally spaced apart from the distal cells. Various strut configurations and connections of the struts to the proximal cells and of the proximal cells to the support post improve stent flexibility and reduce stress in the valve leaflets.

Abstract: A medical device delivery system includes an inner shaft having a proximal end and a distal end, a support shaft having a proximal end and a distal end and an articulating assembly disposed between the inner shaft and the support shaft. The support shaft is sized for insertion into the circulatory system of a patient. The articulating assembly includes a first portion extending from the distal end of the inner shaft and a second portion at the proximal end of the support shaft. The first portion is pivotable relative to the second portion to change orientation of the support shaft relative to the inner shaft. A retainer is secured to a portion of the articulating assembly and is configured to retain a medical device on the support shaft between the retainer and the distal end of the support shaft.

Abstract: A prosthetic heart valve includes a stent having an expanded condition and a collapsed condition. The stent includes a plurality of distal cells, a plurality of proximal cells, a plurality of support struts coupling the proximal cells to the distal cells, and at least one support post connected to a plurality of proximal cells. The proximal cells are longitudinally spaced apart from the distal cells. Various strut configurations and connections of the struts to the proximal cells and of the proximal cells to the support post improve stent flexibility and reduce stress in the valve leaflets.

Abstract: A delivery device (10) for a collapsible prosthetic heart valve may include an operating handle (20, 220, 320) having a housing (30, 230, 330) and a carriage selectively (40) fixed or movable relative to the housing, and a catheter assembly (16, 116, 216, 416). The catheter assembly may have an inner shaft (26, 126, 226, 326, 426) around which a compartment (23) is defined, an outer shaft (22) surrounding at least a portion of the inner shaft, a distal sheath (24) fixedly connected to the outer shaft, and a mechanism configured to apply a distal force to the outer shaft while the carriage (40) is fixed relative to the housing (30, 230, 330) to stretch the outer shaft from a compressed length to an extended length. The extended length may be greater than the compressed length along an axis of elongation of the outer shaft (22).

Abstract: An apparatus for simulation of an anatomical structure may include a left ventricle component having an inlet port configured to receive fluid flow therethrough, an aortic arch component having an outlet port configured to receive fluid flow therethrough, an aortic annulus component attached to and disposed between the left ventricle component and the aortic arch component, and an introducer configured to receive an elongated catheter assembly therethrough. The aortic annulus component may have an inner surface including simulated stenotic nodules. The introducer may be in fluid communication with at least one of the left ventricle component and the aortic arch component.