Abstract: This invention provides, in certain aspects, unique devices and methods for treating fistulae. In one embodiment, an inventive device includes an elongate graft body having a proximal end and a distal end. The graft body is configurable to a first condition and a second condition, the second condition including the distal end deflected laterally relative to its position in the first condition of the body. The device also includes a tether, which is connected to the graft body, and is configured to traverse proximally along the body. The tether is manipulable to convert the graft body from the first condition to the second condition. Such a device may also include one or more additional tethers connected to the graft body. For instance, a second tether can be configured to extend distally from the distal end of the graft body, and may be effective in pulling the graft body along a fistula tract.

Abstract: Described are vascular valve devices for implantation in a patient. The vascular valve devices are designed to compensate for the retraction characteristics of a remodelable material used to form one or more leaflets. Alternatively, or in addition, the devices are designed to reduce retraction of the remodelable leaflet-forming material. Further described are methods for preparing and using these vascular valve devices.

Abstract: Tissue augmentation devices, as well as methods of manufacturing and using the same, are disclosed. In certain embodiments, a tissue augmentation device comprises an elongate tissue penetrating member and an amount of remodelable material, wherein at least a portion of the elongate member is cannulated, and at least a portion of the amount of material is received within at least a portion of the cannulated portion of the elongate member. The elongate tissue penetrating member may provide at least one deformation that is configured to constrict portions of the amount of remodelable material received within the elongate member. In alternate embodiments, a flexible covering over an implantable biomaterial provides protection and allows an easier delivery of the biomaterial to a tissue tract.

Abstract: This invention relates in one aspect to the treatment of a valve-associated region of a vascular vessel with a biomaterial. The biomaterial can be a remodelable material that strengthens and/or supports the vessel walls. Additionally the biomaterial can include a variety of naturally occurring or added bioactive agents and/or viable cellular populations.

Abstract: Described are medical graft products, systems, and methods for treating fistulae. Certain products of the invention are configured to have portions residing in and around a primary fistula opening, e.g., one occurring in a wall of the alimentary canal. One such product includes a biocompatible graft body which is configured to block at least the primary opening. The graft body includes a capping member, which is configured to contact portions of the alimentary canal wall adjacent to the primary opening, and an elongate plug member extending from the capping member, which is configured to extend into at least a portion of the fistula. In certain embodiments, a graft body component has the capacity to expand or otherwise change form to provide a suitable capping arrangement. Such a component can include a resilient wire frame, e.g., one that is self-expandable or one that requires at least some manipulation in order to expand.