Abstract: A prosthesis can comprise an expandable frame, a plurality of distal anchors and a plurality of proximal anchors. The anchors can extend outwardly from the frame. The frame can be configured to radially expand and contract for deployment within a body cavity. The frame and anchors can have one of many different shapes and configurations. For example, when the frame is in an expanded configuration, the frame can have a larger cross-sectional dimension in a middle portion of the frame and a smaller cross-sectional dimension in a proximal portion and a distal portion of the frame, wherein the middle portion is between the proximal and distal portions. As another example, the anchors can have looped ends, the entire anchor may loop out from the frame.

Abstract: Some embodiments described herein include a heart valve replacement system that may be delivered to the targeted heart valve site via a delivery catheter. In some embodiments, the heart valve replacement system can assemble a valve device after the valve device is delivered to the heart. In some embodiments, heart valve replacement system includes two anterior flaps that are separate but overlap each other.

Abstract: A prosthetic heart valve may include an expandable stent, a cuff attached to an annulus section of the stent, and a plurality of leaflets disposed within an interior region of the stent and attached to at least one of the cuff or 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 primary leaflet material, as well as features that reinforce specific regions of the leaflet.

Abstract: Prosthetic heart valve assemblies and methods, apparatus, and systems used to deliver a prosthetic heart valve assembly. A prosthetic heart valve assembly includes an inner frame, a prosthetic leaflet section disposed within the inner frame extending between in inflow row of cells and an outflow row of cells of the inner frame, and an outer support stent. The inner frame is disposed within the outer support stent, and the outer support stent is coupled and/or fastened to the inner frame. The outer support stent includes a plurality leaflet capturing arms for capturing native leaflets between the leaflet capturing arms and a portion of the prosthetic heart valve assembly when the prosthetic heart valve assembly is implanted in a native valve. For example, the native leaflets can be frictionally secured between the leaflet capturing arms of the support stent and the inner frame.

Abstract: A method of providing a Vertebral Body Replacement (VBR) device for placement into a cervical spine between two endplates of a single vertebra during the course of an anterior spinal surgical procedure upon the cervical spine, wherein the VBR device has been given a PLR product code from the Food and Drug Administration (FDA).

Abstract: A prosthetic aortic valve device, delivery system, interventional system, and related method are disclosed. The device includes an inner frame having relative compressed and expanded configurations; leaflets connected to the inner frame and cooperating with each other to control opening and closing of the blood flow passage; and a positioning mechanism arranged in a circumferential direction of the inner frame, the positioning mechanism including a fixed end connected to the inner frame and a free end extending towards the inflow end, the positioning mechanism being configured to be switchable among a loaded configuration, a transition configuration, and a released configuration.

Abstract: Devices and methods are configured to allow transcarotid or subclavian access via the common carotid artery to the native aortic valve, and implantation of a prosthetic aortic valve into the heart. The devices and methods also provide means for embolic protection during such an endovascular aortic valve implantation procedure.

Abstract: A transcatheter valve prosthesis includes an expandable tubular stent, a prosthetic valve within the stent, and an anti-paravalvular leakage component coupled to and encircling the tubular stent. The anti-paravalvular leakage component includes a radially-compressible annular scaffold, which is a sinusoidal patterned ring of self-expanding material, and an impermeable membrane extending over the annular scaffold. The anti-paravalvular leakage component has an expanded configuration in which at least segments of the annular scaffold curve radially away from the tubular stent. Alternatively, the anti-paravalvular leakage component includes a plurality of self-expanding segments and an annular sealing element coupled to inner surfaces of the segments. The anti-paravalvular leakage component has an expanded configuration in which the segments curve radially away from the tubular stent and the annular sealing element is positioned between an outer surface of the tubular stent and inner surfaces of the segments.

Abstract: Devices, systems, and methods for combinatorial treatment of a condition with an implantable damping device and therapeutic agent (e.g., drug) are disclosed herein. Methods for treating one or more effects of the condition, such as a neurological condition, include providing the implantable damping device and at least one other therapy, such as a therapeutic agent, that treats the condition to the patient. The implantable damping device includes a flexible damping member and an abating substance and can be placed in apposition with a blood vessel. The flexible damping member forms a generally tubular structure having an inner and an outer surface, the inner surface formed of a sidewall having a partially deformable portion. The abating substance is disposed within the partially deformable portion and moves longitudinally and/or radially within the partially deformable portion in response to pulsatile blood flow.

Abstract: A device for treating a diseased native valve in a patient is provided, the device including a frame structure and a plurality of leaflets. The device can further include a spiral anchor configured to extend around an outer circumference of the frame structure. The anchor can be configured to deliver a contrast agent into or near a target tissue. Other embodiments and methods of use are also provided.

Abstract: An apparatus includes a first layer, wherein the first layer comprises a scaffold structure forming an inner lumen along a length of the scaffold structure, and wherein the first layer comprises a bioresorbable material; a second layer on the first layer, wherein the second layer comprises a bioresorbable material configured to expand, wherein the second layer is positioned on the first layer such that ends of the first layer extend beyond ends of the second layer; and an expandable balloon located within a distal end of the inner lumen of the first layer.

Abstract: A valved conduit including a bioprosthetic aortic heart valve connected to a tubular conduit graft forming an ascending aorta. The conduit graft may attach to the heart valve in a manner that facilitates a redo operation in which the valve is replaced with another valve. A sewing ring may be pre-attached to the inflow end of the graft, and then the valve connected to a delivery holder advanced into the graft and secured to the sewing ring. Dry bioprosthetic valves coupled with conduit grafts sealed with a bioresorbable medium can be stored with the delivery holder.

Abstract: A prosthetic heart valve (e.g., a prosthetic aortic valve) is designed to be somewhat circumferentially collapsible and then re-expandable. The collapsed condition may be used for less invasive delivery of the valve into a patient. When the valve reaches the implant site in the patient, it re-expands to normal operating size, and also to engage surrounding tissue of the patient. The valve includes a stent portion and a ring portion that is substantially concentric with the stent portion but downstream from the stent portion in the direction of blood flow through the implanted valve. When the valve is implanted, the stent portion engages the patient's tissue at or near the native valve annulus, while the ring portion engages tissue downstream from the native valve site (e.g., the aorta).

Abstract: Transcatheter aortic valve prostheses for improving the cardiac function of a patient suffering from coronary artery disease. Transcatheter aortic valve prostheses include a valve component and a frame. The valve component includes valve leaflets and a skirt. The frame includes access cells that improve access to a patient's coronary arteries if further intervention is required and/or includes a window or conduction protection cell that is oriented to align with a portion of conduction system of the heart in situ to reduce conduction disturbances of the anatomy. Suture patterns for attaching a commissure to a commissure post of the frame, and for attaching a tissue bumper to the commissure post, are also described.

Abstract: A side-deliverable prosthetic heart valve includes an outer frame and a flow control component. The outer frame defines a central channel that extends along a central axis. The flow control component is disposed within the central channel and coupled to the outer frame. The flow control component has a set of leaflets mounted within an inner frame. The prosthetic valve is configured to be folded along a longitudinal axis and compressed along the central axis to place the prosthetic valve in a compressed configuration for delivery via a delivery catheter. The longitudinal axis is substantially parallel to a lengthwise axis of the delivery catheter when disposed therein. The prosthetic valve transitions to an expanded configuration when released from the delivery catheter. The flow control component elastically deforms from a substantially cylindrical configuration to a substantially flattened configuration when the prosthetic valve is placed in the compressed configuration.

Abstract: Apparatus, systems, and methods for inserting prosthesis implants into surgically-created implant pockets in a subject and for preventing capsular contracture resulting from surgical insertion of prosthesis implants. The apparatus includes a base having an upper surface and a lower surface and having an aperture formed therein which extends through the upper surface and the lower surface of the base. The apparatus also includes a tubular member that is coupled to the base. The inner bore of the tubular member is operable to receive the implant and has a substantially uniform cross-sectional width over the predetermined length. The apparatus is capable of shielding the implant from microbial contamination, including contamination by the endogenous flora of the subject, during insertion of the implant into the surgically-created implant pocket.

Abstract: A prosthetic heart valve is designed to be circumferentially collapsible for less invasive delivery into the patient. At the implant site the valve re-expands to a larger circumferential size, i.e., the size that it has for operation as a replacement for one of the patient's native heart valves. The valve includes structures that, at the implant site, extend radially outwardly to engage tissue structures above and below the native heart valve annulus. These radially outwardly extending structures clamp the native tissue between them and thereby help to anchor the prosthetic valve at the desired location in the patient.

Abstract: A patch for interposing between an implantable device and a treatment site, such as to inhibit migration (e.g., lateral shifting) of the implantable device with respect to the treatment site without interfering with contact of the implantable device with the treatment site, and/or to reduce (and preferably inhibit or prevent) damage to tissue at the treatment site and/or movement of the anchor element (used to anchor the implantable device) with respect to the treatment site. The patch may extend continuously around the perimeter of the device, or discontinuously as more than one patch. The patch may be delivered on the implantable device to the treatment site, or separately delivered and deployed before the implantable device is delivered and deployed, the implantable device being implanted over the patch and the treatment site.

Abstract: A prosthetic heart valve is disclosed that is deformable between collapsed, radially uncompressed, and target conditions. The prosthetic heart valve includes an inner frame, at least one leaflet, and a braided wire mesh arranged outside and coupled to the inner frame by a coupling portion. The braided wire mesh includes a body portion between the coupling portion and a flared portion. In the radially uncompressed condition, the prosthetic heart valve forms a cavity surrounded by the braided wire mesh and the inner frame. In the target condition, only a part of the length of the body portion is radially compressed along an axis extending from an upstream side to a downstream side. In the collapsed condition, the inner frame and braided wire mesh are radially collapsed over their entire length. In the radially uncompressed condition, the body portion is tubular and the braided wire mesh has a rotationally symmetric circumference.

Abstract: A prosthetic heart valve assembly includes a self-expandable stent having a flared upper portion, a lower portion, and an intermediate portion extending from the upper portion to the lower portion. The stent includes upwardly bent hooks extending from an outer surface of the stent, which are adapted to engage native leaflet tissue. The stent further includes an elongate anchoring member extending from the lower portion of the stent, which is adapted to be secured to a ventricle wall via a prong portion. When deployed within the native heart valve, the flared upper portion contacts a supra-annular surface of the native heart valve for preventing downward migration of the prosthetic heart valve assembly toward the ventricle and the upwardly bent hooks and the elongate anchoring member prevent upward migration of the prosthetic heart valve assembly toward an atrium.