This invention relates, e.g., to a Myocyte-based Flow Assist Device (MFAD) for treating a subject in need of increased flow of a biological fluid, such as venous blood or lymph, comprising a sheath which comprises rhythmically contracting myocytes.

An artificial heart valve includes a frame, one or more struts attached to the frame, and a leaflet configured to open and close a fluid flow path through the frame by moving in response to heartbeats. Movement of the leaflet is restricted by the one or more struts. The leaflet includes an inner leaflet body having a negative Poisson's ratio, and an outer leaflet body at least partially surrounding the inner leaflet body, the outer leaflet body having a positive Poisson's ratio.

A synthetic construct suitable for implantation into a biological organism that includes at least one polymer scaffold; wherein the at least one polymer scaffold includes at least one layer of polymer fibers that have been deposited by electrospinning; wherein the orientation of the fibers in the at least one polymer scaffold relative to one another is generally parallel, random, or both; and wherein the at least one polymer scaffold has been adapted to function as at least one of a substantially two-dimensional implantable structure and a substantially three-dimensional implantable tubular structure.

In one embodiment, an implantable prosthetic valve can comprise an annular frame comprising an inflow end and an outflow end and being radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration, and a leaflet structure positioned within the frame and secured thereto. The prosthetic valve can further comprise an outer skirt positioned around an outer surface of the frame, the outer skirt comprising pericardial tissue having a fibrous parietal layer defining a first surface of the outer skirt and a serous parietal layer defining a second surface of the outer skirt, the pericardial tissue having been fixed by cross-linking.

Described herein are regenerative approaches with tunable cell-cell and cell-matrix interactions to enhance the ability to regenerate multiple zones within a construct with each zone possessing a unique, optimum, level of cell-cell and cell-matrix interaction.

A method is provided for preparing an ECM material, including an ECM gel, from regenerative or regenerating tissue. ECM material prepared from regenerative or regenerating materials also is provided.

The invention concerns the treatment of bioprosthetic tissues a Cyclodextrin, preferably in association with Ethanol.

A replacement mitral valve prosthesis includes a support structure and a valve body having three flexible leaflets. The support structure preferably includes an internal valve frame and an external sealing frame. The valve frame supports the flexible leaflets. The sealing frame is adapted to conform to the shape of the native mitral valve annulus. The sealing frame may be coupled to an inlet end of the valve frame, an outlet end of the valve frame, or both. A plurality of anchors is coupled to the outlet end of the valve frame. The anchors extend radially outwardly for placement behind native leaflets. The prosthesis preferably includes a skirt disposed along an exterior of the external sealing frame. The prosthesis is collapsible for delivery into the heart via a delivery catheter. The prosthesis is configured to self-expand for deployment in the heart when released from the delivery catheter.

An anti-fouling implantable material and a method of making the anti-fouling implantable material are disclosed. The anti-fouling implantable material includes a polymeric reinforcement layer, an intermediate layer comprising a protective polymer membrane, and an outer layer comprising an ionic polymer. The anti-fouling implantable material may have chemical and/or physical properties compatible with body tissue properties. The anti-fouling implantable material may be used for implantable medical devices, such as prosthetic heart valves and vascular grafts, among others.

Methods for generating aortic heart valve leaflets are disclosed wherein the aortic sinus surfaces (the inner surfaces of the sinuses of Valsalva) are used as a template to generate geometric representations of replacement aortic heart valve leaflets. As such, sinus-matched replacement leaflets can be sized and shaped according to the patient-specific geometry of the aortic root. Patient-specific aortic valve assemblies based on aortic root and sinus geometry are also described. Methods for estimating the coaptation area of a sinus-matched valve and assessing whether the valve is functionally competent for implantation are described.