Abstract: A prosthetic heart valve includes a valve frame defining an aperture that extends along a central axis and a flow control component mounted within the aperture. The valve frame includes a distal anchoring element and a proximal anchoring element. The valve frame has a compressed configuration to allow the valve to be delivered to a heart of a patient via a delivery catheter. The valve frame is configured to transition to an expanded configuration when released from the delivery catheter. The valve is configured to be seated in a native annulus when the valve frame is in the expanded configuration. The distal and proximal anchoring elements configured to be inserted through the native annulus prior to seating the valve. The proximal anchoring element is ready to be deployed subannularly or is optionally configured to be transitioned from a first configuration to a second configuration after the valve is seated.

Abstract: A side-deliverable prosthetic heart valve includes an outer frame and a flow control component. The outer frame has a supra-annular region, a subannular region, and a transannular region therebetween. The flow control component is mounted to the outer frame such that at least a portion of the flow control component is disposed in the transannular region. The prosthetic valve has a delivery configuration for side-delivery via a delivery catheter and is expandable when the prosthetic valve is released from the delivery catheter. The subannular region of the outer frame is disposable in a first configuration as the prosthetic valve is seated in an annulus of a native heart valve and is transitionable to a second configuration after the prosthetic valve is seated in the annulus of the native heart valve.

Abstract: A side-deliverable prosthetic heart valve includes an outer frame and a flow control component. The outer frame has a supra-annular region, a subannular region, and a transannular region therebetween. The flow control component is mounted to the outer frame such that at least a portion of the flow control component is disposed in the transannular region. The prosthetic valve has a delivery configuration for side-delivery via a delivery catheter and is expandable when the prosthetic valve is released from the delivery catheter. The subannular region of the outer frame is disposable in a first configuration as the prosthetic valve is seated in an annulus of a native heart valve and is transitionable to a second configuration after the prosthetic valve is seated in the annulus of the native heart valve.

Abstract: An electro-anatomical model of the mammalian His/Purkinje system includes a shell simulating the anatomy of at least a portion of a mammalian heart. The shell has a hollow interior and a first port providing an aperture to the interior of the shell. A plug is inserted in the first port so that a surface of the plug is exposed to the interior of the shell. An electrical circuit provides signals to electrodes in the plug which simulate the electrical signals generated by the bundle of His/Purkinje system in vivo. A second port provides access to the interior of the shell for an introducer catheter to locate the simulated bundle of His and to insert a pacing lead therein. The model is useful for developing tools for His pacing and for training users in techniques for implanting His pacing leads.

Abstract: A prosthetic heart valve includes a valve frame defining an aperture that extends along a central axis and a flow control component mounted within the aperture. The valve frame includes a distal anchoring element and a proximal anchoring element. The valve frame has a compressed configuration to allow the prosthetic heart valve to be delivered to a heart of a patient via a delivery catheter. The valve frame is configured to transition to an expanded configuration when released from the delivery catheter. The prosthetic heart valve is configured to be seated in a native annulus when the valve frame is in the expanded configuration. The distal and proximal anchoring elements configured to be inserted through the native annulus prior to seating the prosthetic heart valve. The proximal anchoring element is ready to be deployed subannularly or is optionally configured to be transitioned from a first configuration to a second configuration after the prosthetic valve is seated.

Abstract: A delivery system for side-delivery of a prosthetic valve includes a compression device defining a lumen having a first perimeter at a proximal end that is larger than a second perimeter of the lumen at a distal end. A loading device is coupleable to the compression device and defines a lumen having substantially the second perimeter. A distal end of the loading device includes a first gate that is movable between an open state and a closed state to at least partially occlude the lumen of the loading device. A delivery device defines a lumen having substantially the second perimeter. A proximal end of the delivery device is coupleable to the distal end of the loading device and includes a second gate movable between an open state and a closed state to at least partially occlude the lumen of the delivery device.

Abstract: A delivery system for side-delivery of a prosthetic valve includes a compression device defining a lumen having a first perimeter at a proximal end that is larger than a second perimeter of the lumen at a distal end. A loading device is coupleable to the compression device and defines a lumen having substantially the second perimeter. A distal end of the loading device includes a first gate that is movable between an open state and a closed state to at least partially occlude the lumen of the loading device. A delivery device defines a lumen having substantially the second perimeter. A proximal end of the delivery device is coupleable to the distal end of the loading device and includes a second gate movable between an open state and a closed state to at least partially occlude the lumen of the delivery device.

Abstract: A side-deliverable prosthetic heart valve includes an outer frame and a flow control component. The outer frame has a supra-annular region, a subannular region, and a transannular region therebetween. The flow control component is mounted to the outer frame such that at least a portion of the flow control component is disposed in the transannular region. The prosthetic valve has a delivery configuration for side-delivery via a delivery catheter and is expandable when the prosthetic valve is released from the delivery catheter. The subannular region of the outer frame is disposable in a first configuration as the prosthetic valve is seated in an annulus of a native heart valve and is transitionable to a second configuration after the prosthetic valve is seated in the annulus of the native heart valve.

Abstract: A side-deliverable prosthetic valve includes an outer frame, a flow control component mounted within the outer frame, and an anchoring element coupled to a distal side of the outer frame. The prosthetic valve is foldable along a longitudinal axis and compressible along a central axis to a compressed configuration for side delivery via a delivery catheter and is expandable to an expanded configuration when released from the delivery catheter. An end portion of the anchoring element is configured to engage a guide wire. The anchoring element is extended during deployment to allow the anchoring element to capture at least one of native leaflet or chordae and, in response to the guide wire being disengaged from the end portion, transitions to a folded configuration to secure at least one of the native leaflet or the chordae between the anchoring element and the distal side of the outer frame.

Abstract: A delivery system for side-delivery of a prosthetic valve includes a compression device defining a lumen having a first perimeter at a proximal end that is larger than a second perimeter of the lumen at a distal end. A loading device is coupleable to the compression device and defines a lumen having substantially the second perimeter. A distal end of the loading device includes a first gate that is movable between an open state and a closed state to at least partially occlude the lumen of the loading device. A delivery device defines a lumen having substantially the second perimeter. A proximal end of the delivery device is coupleable to the distal end of the loading device and includes a second gate movable between an open state and a closed state to at least partially occlude the lumen of the delivery device.

Abstract: A delivery system for side-delivery of a prosthetic valve includes a compression device defining a lumen having a first perimeter at a proximal end that is larger than a second perimeter of the lumen at a distal end. A loading device is coupleable to the compression device and defines a lumen having substantially the second perimeter. A distal end of the loading device includes a first gate that is movable between an open state and a closed state to at least partially occlude the lumen of the loading device. A delivery device defines a lumen having substantially the second perimeter. A proximal end of the delivery device is coupleable to the distal end of the loading device and includes a second gate movable between an open state and a closed state to at least partially occlude the lumen of the delivery device.

Abstract: The present invention is directed to a proximal anchoring tab for a side delivered prosthetic mitral valve having an elongated distal tab, where the proximal tab anchors the proximal side of the prosthetic valve using a tab or loop deployed to the A3-P3 (proximal) commissure area of the mitral valve, and wherein the elongated distal tab is extended around the posterior P1-P2 leaflet and/or chordae using a guide wire to capture native mitral leaflet and/or chordae tissue and where withdrawing the guide wire contracts the tab and pins the native posterior tissue against the subannular posterior-side sidewall of the prosthetic valve.

Abstract: A prosthetic heart valve includes a valve frame defining an aperture that extends along a central axis and a flow control component mounted within the aperture. The valve frame includes a distal anchoring element and a proximal anchoring element. The valve frame has a compressed configuration to allow the prosthetic heart valve to be delivered to a heart of a patient via a delivery catheter. The valve frame is configured to transition to an expanded configuration when released from the delivery catheter. The prosthetic heart valve is configured to be seated in a native annulus when the valve frame is in the expanded configuration. The distal and proximal anchoring elements configured to be inserted through the native annulus prior to seating the prosthetic heart valve. The proximal anchoring element is ready to be deployed subannularly or is optionally configured to be transitioned from a first configuration to a second configuration after the prosthetic valve is seated.

Abstract: A side-deliverable prosthetic heart valve includes an outer frame and a flow control component. The outer frame has a supra-annular region, a subannular region, and a transannular region therebetween. The flow control component is mounted to the outer frame such that at least a portion of the flow control component is disposed in the transannular region. The prosthetic valve has a delivery configuration for side-delivery via a delivery catheter and is expandable when the prosthetic valve is released from the delivery catheter. The subannular region of the outer frame is disposable in a first configuration as the prosthetic valve is seated in an annulus of a native heart valve and is transitionable to a second configuration after the prosthetic valve is seated in the annulus of the native heart valve.

Abstract: A delivery system for side-delivery of a prosthetic valve includes a compression device defining a lumen having a first perimeter at a proximal end that is larger than a second perimeter of the lumen at a distal end. A loading device is coupleable to the compression device and defines a lumen having substantially the second perimeter. A distal end of the loading device includes a first gate that is movable between an open state and a closed state to at least partially occlude the lumen of the loading device. A delivery device defines a lumen having substantially the second perimeter. A proximal end of the delivery device is coupleable to the distal end of the loading device and includes a second gate movable between an open state and a closed state to at least partially occlude the lumen of the delivery device.

Abstract: A side-deliverable prosthetic valve includes an outer frame, a flow control component mounted within the outer frame, and an anchoring element coupled to a distal side of the outer frame. The prosthetic valve is foldable along a longitudinal axis and compressible along a central axis to a compressed configuration for side delivery via a delivery catheter and is expandable to an expanded configuration when released from the delivery catheter. An end portion of the anchoring element is configured to engage a guide wire. The anchoring element is extended during deployment to allow the anchoring element to capture at least one of native leaflet or chordae and, in response to the guide wire being disengaged from the end portion, transitions to a folded configuration to secure at least one of the native leaflet or the chordae between the anchoring element and the distal side of the outer frame.

Abstract: A delivery device for delivering a pacing lead to the His bundle of a patient's heart includes an elongated sheath having a distal end, and a plurality of mapping electrodes positioned at the distal end. The distal end of the sheath may have a distal tip, and the mapping electrodes may include two electrodes that diametrically oppose one another at a position spaced from the distal tip of the sheath. The sheath includes a plurality of flexible sections spaced apart from one another, and a pull wire that causes the sheath to deflect from a straight configuration to a dual hinged curved configuration that positions the electrodes in the vicinity of the bundle of His.

Abstract: Systems and methods for computing a causal uplift in performance of an output action for one or more treatment actions in parallel are described herein. In an embodiment, a server computer receives interaction data for a particular period of time which identifies a plurality of users and a plurality of actions that were performed by each user of the plurality of users through a particular graphical user interface during the particular period of time. The server computer uses the interaction data to generate a feature matrix of actions for each user, and a set of confounding variables included to minimize spurious correlations. The feature matrix is then used to train a machine learning system, using data identifying a user's performance or non-performance of each action as inputs and data identifying performance or non-performance of a target output action as the output.

Abstract: Described are systems and methods to provide agnostic sensor data obtained from a sensor and transmitted to a central database by a transmitter device. In one aspect, a value sensed by a sensor component is converted at the transmitter device to an agnostic value defined by a dimensionless universal scale and offset. The agnostic value is then sent to a data acquisition database where it is converted back to the original value. This is accomplished by first providing the data acquisition database with a sensor definition of a scale and offset used to convert the sensor values in addition to any sensor indicia and other parameters to display the data acquired at the data acquisition database. The wireless sensors database and user interface are also automatically updated when a new sensor type is attached to the network utilizing configuration data that resides in the new sensor that is sent to the database on its first connection.

Abstract: The present invention is directed to a proximal anchoring tab for a side delivered prosthetic mitral valve having an elongated distal tab, where the proximal tab anchors the proximal side of the prosthetic valve using a tab or loop deployed to the A3-P3 (proximal) commissure area of the mitral valve, and wherein the elongated distal tab is extended around the posterior P1-P2 leaflet and/or chordae using a guide wire to capture native mitral leaflet and/or chordae tissue and where withdrawing the guide wire contracts the tab and pins the native posterior tissue against the subannular posterior-side sidewall of the prosthetic valve.