Abstract: Systems, devices, and methods for providing access to the heart. The system includes an intracardiac access device comprising an elongate member having a channel extending between a distal end and a proximal end thereof. The intracardiac access device is configured to be advanced through an extrapericardial penetration in the left atrial wall without penetrating the pericardium of the heart. An optional procedural device is configured to be advanced through the channel of the intracardiac access device into an internal chamber of the heart and configured to perform a surgical procedure in the internal chamber of the heart. A working channel of an optional suprasternal access device is configured to facilitate access of the intracardiac access device into the body of the patient by providing a path from a suprasternal opening to a position adjacent the roof of the left atrium.

Abstract: Systems for mitral valve repair are disclosed where one or more mitral valve interventional devices may be advanced intravascularly into the heart of a patient and deployed upon or along the mitral valve to stabilize the valve leaflets. The interventional device may also facilitate the placement or anchoring of a prosthetic mitral valve implant. The interventional device may generally comprise a distal set of arms pivotably and/or rotating coupled to a proximal set of arms which are also pivotably and/or rotating coupled. The distal set of arms may be advanced past the catheter opening to a subannular position (e.g., below the mitral valve) and reconfigured from a low-profile delivery configuration to a deployed securement configuration. The proximal arm members may then be deployed such that the distal and proximal arm members may grip the leaflets between the two sets of arms to stabilize the leaflets.

Abstract: Systems for mitral valve repair are disclosed where one or more mitral valve interventional devices may be advanced intravascularly into the heart of a patient and deployed upon or along the mitral valve to stabilize the valve leaflets. The interventional device may also facilitate the placement or anchoring of a prosthetic mitral valve implant. The interventional device may generally comprise a distal set of arms pivotably and/or rotating coupled to a proximal set of arms which are also pivotably and/or rotating coupled. The distal set of arms may be advanced past the catheter opening to a subannular position (e.g., below the mitral valve) and reconfigured from a low-profile delivery configuration to a deployed securement configuration. The proximal arm members may then be deployed such that the distal and proximal arm members may grip the leaflets between the two sets of arms to stabilize the leaflets.

Abstract: Systems and methods are disclosed that provide for regular, periodic or continuous monitoring of fluid volume based on direct measurement of an inferior vena cava (IVC) physical dimension using a wireless measurement sensor implanted in the IVC. By basing diagnostic decisions and treatments on changes in an IVC physical dimension, information on patient fluid state is available across the entire euvolemic range of fluid states, thus providing earlier warning of hypervolemia or hypovolemia and enabling the modulation of patient treatments to permit more stable long-term fluid management.

Abstract: Systems and methods for closed-loop control of heart failure interventional therapies using closed-loop feedback from vascular implanted cardiac health status sensors are disclosed.

Abstract: Systems and methods are disclosed that provide for regular, periodic or continuous monitoring of fluid volume based on direct measurement of an inferior vena cava (IVC) physical dimension using a wireless measurement sensor implanted in the IVC. By basing diagnostic decisions and treatments on changes in an IVC physical dimension, information on patient fluid state is available across the entire euvolemic range of fluid states, thus providing earlier warning of hypervolemia or hypovolemia and enabling the modulation of patient treatments to permit more stable long-term fluid management.

Abstract: Systems, devices, and methods for performing catheter-based procedures in the heart. In specific embodiments a procedural catheter is introduced into the mediastinum from a suprasternal access site. The procedural catheter is passed through a wall of the heart, preferably at an extrapericardial location on the atrial dome. The procedural catheter is used to perform a procedure in the heart such as mitral valve repair or replacement, using remote catheter visualization techniques.

Abstract: Prosthetic heart valve devices for percutaneous replacement of native heart valves and associated systems and method are disclosed herein. A prosthetic heart valve device configured in accordance with a particular embodiment of the present technology can include an anchoring member having a first portion configured to engage with tissue on or near the annulus of the native heart valve and to deform in a non-circular shape to conform to the tissue. The device can also include a valve support coupled to a second portion of the anchoring member, configured to support a prosthetic valve and having a cross-sectional shape. In some embodiments, the first portion of the anchoring member is mechanically isolated from the valve support such that the cross-sectional shape of the valve support remains sufficiently stable that the prosthetic valve remains competent when the anchoring member is deformed in the non-circular shape.

Abstract: Methods for patient self-monitoring of vascular lumen dimensions, in particular in the inferior vena cava (IVC) for determining heart failure status of a patient. Related therapy systems as well as monitoring and therapy methods are also disclosed.

Abstract: Various devices, systems and methods for knotless suturing of tissue are disclosed. These devices allow sutures to be anchored to bone, and more specifically provide a suture anchor which eliminates the need for knotting the suture. Thus, damaged tissue may be re-attached to a substrate tissue. The anchors have a minimum of moving parts may be suited to being a single molded polymer construction. The anchors will find particular utility in hip and shoulder arthroscopy, e.g. labral re-attachment and similar procedures.

Abstract: Prosthetic heart valve devices for percutaneous replacement of native heart valves and associated systems and method are disclosed herein. A prosthetic heart valve device configured in accordance with a particular embodiment of the present technology can include an anchoring member having a first portion configured to engage with tissue on or near the annulus of the native heart valve and to deform in a non-circular shape to conform to the tissue. The device can also include a valve support coupled to a second portion of the anchoring member, configured to support a prosthetic valve and having a cross-sectional shape. In some embodiments, the first portion of the anchoring member is mechanically isolated from the valve support such that the cross-sectional shape of the valve support remains sufficiently stable that the prosthetic valve remains competent when the anchoring member is deformed in the non-circular shape.

Abstract: Implantable devices for continuously monitoring vascular lumen dimensions, in particular in the inferior vena cava (IVC) for determining heart failure status of a patient. Related therapy systems as well as monitoring and therapy methods are also disclosed. Devices include active or passive marker elements placed in contact with, adhered to or injected into the vessel wall to generate or reflect signals from which lumen diameter may be determined. Disclosed devices may be fully implantable and self-contained including capabilities for wirelessly communication monitored parameters.

Abstract: Systems, devices, and methods for providing access to the heart. The system includes an intracardiac access device comprising an elongate member having a channel extending between a distal end and a proximal end thereof. The intracardiac access device is configured to be advanced through an extrapericardial penetration in the left atrial wall without penetrating the pericardium of the heart. An optional procedural device is configured to be advanced through the channel of the intracardiac access device into an internal chamber of the heart and configured to perform a surgical procedure in the internal chamber of the heart. A working channel of an optional suprasternal access device is configured to facilitate access of the intracardiac access device into the body of the patient by providing a path from a suprasternal opening to a position adjacent the roof of the left atrium.

Abstract: Systems for mitral valve repair are disclosed where one or more mitral valve interventional devices may be advanced intravascularly into the heart of a patient and deployed upon or along the mitral valve to stabilize the valve leaflets. The interventional device may also facilitate the placement or anchoring of a prosthetic mitral valve implant. The interventional device may generally comprise a distal set of arms pivotably and/or rotating coupled to a proximal set of arms which are also pivotably and/or rotating coupled. The distal set of arms may be advanced past the catheter opening to a subannular position (e.g., below the mitral valve) and reconfigured from a low-profile delivery configuration to a deployed securement configuration. The proximal arm members may then be deployed such that the distal and proximal arm members may grip the leaflets between the two sets of arms to stabilize the leaflets.

Abstract: Systems for mitral valve repair are disclosed where one or more mitral valve interventional devices may be advanced intravascularly into the heart of a patient and deployed upon or along the mitral valve to stabilize the valve leaflets. The interventional device may also facilitate the placement or anchoring of a prosthetic mitral valve implant. The interventional device may generally comprise a distal set of arms pivotably and/or rotating coupled to a proximal set of arms which are also pivotably and/or rotating coupled. The distal set of arms may be advanced past the catheter opening to a subannular position (e.g., below the mitral valve) and reconfigured from a low-profile delivery configuration to a deployed securement configuration. The proximal arm members may then be deployed such that the distal and proximal arm members may grip the leaflets between the two sets of arms to stabilize the leaflets.

Abstract: Systems and methods are disclosed that provide for regular, periodic or continuous monitoring of fluid volume based on direct measurement of an inferior vena cava (IVC) physical dimension using a wireless measurement sensor implanted in the IVC. By basing diagnostic decisions and treatments on changes in an IVC physical dimension, information on patient fluid state is available across the entire euvolemic range of fluid states, thus providing earlier warning of hypervolemia or hypovolemia and enabling the modulation of patient treatments to permit more stable long-term fluid management.

Abstract: Prosthetic heart valve devices for percutaneous replacement of native heart valves and associated systems and method are disclosed herein. A prosthetic heart valve device configured in accordance with a particular embodiment of the present technology can include an anchoring member having a first portion configured to engage with tissue on or near the annulus of the native heart valve and to deform in a non-circular shape to conform to the tissue. The device can also include a valve support coupled to a second portion of the anchoring member, configured to support a prosthetic valve and having a cross-sectional shape. In some embodiments, the first portion of the anchoring member is mechanically isolated from the valve support such that the cross-sectional shape of the valve support remains sufficiently stable that the prosthetic valve remains competent when the anchoring member is deformed in the non-circular shape.

Abstract: A prosthetic heart valve (100) includes a flexible anchoring member (110) at least partially surrounding and coupled to an inner valve support (120). The device can further include a prosthetic valve (130) coupled to, mounted within, or otherwise carried by the valve support. The valve support includes a plurality of posts (122) connected circumferentially by a plurality of struts (124), where the posts extend along an axial direction generally parallel to the longitudinal axis (101) and the struts extend circumferentially around and transverse to the longitudinal axis. The posts extend an entire longitudinal height HI of the valve support 120. The device also includes one or more sealing members (140) and tissue engaging elements (170) like spikes.

Abstract: Implantable devices for continuously monitoring vascular lumen dimensions, in particular in the inferior vena cava (IVC) for determining heart failure status of a patient. Related therapy systems as well as monitoring and therapy methods are also disclosed. Devices include active or passive marker elements placed in contact with, adhered to or injected into the vessel wall to generate or reflect signals from which lumen diameter may be determined. Disclosed devices may be fully implantable and self-contained including capabilities for wirelessly communication monitored parameters.

Abstract: Prosthetic heart valve devices for percutaneous replacement of native heart valves and associated systems and method are disclosed herein. A prosthetic heart valve device configured in accordance with a particular embodiment of the present technology can include an anchoring member having a first portion configured to engage with tissue on or near the annulus of the native heart valve and to deform in a non-circular shape to conform to the tissue. The device can also include a valve support coupled to a second portion of the anchoring member, configured to support a prosthetic valve and having a cross-sectional shape. In some embodiments, the first portion of the anchoring member is mechanically isolated from the valve support such that the cross-sectional shape of the valve support remains sufficiently stable that the prosthetic valve remains competent when the anchoring member is deformed in the non-circular shape.