Abstract: In some examples, a prosthetic heart valve system includes an outer stent, an inner stent coupled to the outer stent, the inner stent supporting a valve assembly including a cuff and a plurality of leaflets, and at least one linking member coupling the outer stent to the inner stent, the at least one linking member being transitionable between a collapsed condition and a relaxed condition, the inner stent being axially spaced away from the outer stent when the at least one linking member is in the collapsed condition, and the inner stent being at least partially nested within the outer stent when the at least one linking member is in the relaxed condition.

Abstract: A medical device including a removable frame and biomaterial cover, methods of assembling and using the same, and a delivery system including the same are described herein. The medical device includes a frame having proximal and distal ends, the frame including a proximal disc at the proximal end, a distal disc at the distal end, and a connecting segment having a proximal end and a distal end connecting the proximal and distal discs. Each of the proximal and distal discs includes a respective plurality of prongs and has a maximum cross-sectional dimension larger than the connecting segment. The medical device further includes at least one biomaterial cover including an outer section and an inner section defining a cavity therebetween, wherein at least one of the proximal and distal discs of the frame is positioned in the cavity.

Abstract: A prosthetic heart valve includes a support structure and a valve assembly disposed within the support structure, the valve assembly including a plurality of leaflets. Each leaflet is formed from a predetermined leaflet material. Some leaflet materials include a metal body with a plurality of openings. The metal body may be coated with a polymer. Other leaflet materials include natural mammalian tissue subjected to a plastination preservation process.

Abstract: A method for determining a predicted lesion size formed in a tissue by receiving or calculating a measure of contact force between the electrode and the tissue, determining a tissue characterization, and calculating the predicted lesion size using both the measure of contact force and the tissue characterization. A system comprising an electronic control unit configured to receive or determine a measure of contact force between the electrode and the tissue, characterize the tissue based on both the measure of impedance and the measure of contact force, and cause the tissue characterization to be either (a) presented to a user, or (b) applied to calculate a metric and cause the metric to be presented to the user.

Abstract: A robotic catheter system includes an arch-shaped suspension system comprising a first and second vertical span, a horizontal span between the pair of vertical spans, and at least one robotic catheter head coupled to the horizontal span. The arch-shaped suspension system can include a pair of linear guide blocks that can be attached to a patient bed and in some embodiments the linear guide blocks can be configured to slidably move along a rail. The arch-shaped suspension system can be moved to allow for proper placement of the arch-shaped suspension system for use on a patient or for placing the system away from a patient or for storage. In some embodiments the robotic catheter system can include a suspension system cart for storing and moving the arch-shaped suspension system.

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: Techniques are provided for candidate screening for a target therapy. A plurality of medical codes corresponding to patient billing data are identified. A candidate classification model for a target therapy is generated by selecting a set of medical codes from the plurality of medical codes and assigning a weight to each medical code selected. The candidate classification model is applied to patient billing data for a plurality of patients to generate a set of target therapy scores. The patient billing data includes associations between one or more patients of the plurality of patients and one or more medical codes of the plurality of medical codes. Each target therapy score corresponds to a patient of the plurality of patients, and is calculated based on weights for one or more medical codes associated with the patient.

Abstract: A catheter including a loop member adjustment mechanism for adjusting a diameter of a loop member is provided. The catheter further includes a longitudinally-extending catheter shaft including a proximal end portion and a distal end deflectable portion, wherein the distal end deflectable portion includes the loop member. The loop adjustment mechanism includes a loop member pull wire, wherein a distal end of the loop member pull wire is attached to the loop member, and a sliding member, located within the handle, wherein the sliding member is configured to translate within the handle, and wherein a proximal end of the pull wire is attached to the sliding member.

Abstract: According to one aspect of the disclosure, a prosthetic heart valve includes a collapsible and expandable frame that includes a central portion, and atrial and ventricular portions flaring outwardly from the central portion. A prosthetic valve is housed within the frame. An outer skirt is disposed on an outer surface of the frame, the outer skirt having a first end portion having a first attachment to the atrial portion or the ventricular portion, a second intermediate portion having a second attachment to the frame adjacent the central portion, and a third intermediate portion having a third attachment to the frame adjacent the central portion. Upon transition of the frame from the expanded condition to the collapsed condition, the first attachment does not translate relative to the frame, while the second and third attachments do translate relative to the frame.

Abstract: A deflectable catheter shaft section is disclosed comprising an elongated body extending along a longitudinal axis with a distal end and a proximal end. First and second pull wires can extend along the elongated body and can have a proximal end and a distal end. First and second pull wire liners can be disposed over a portion of one of the first and second pull wires, respectively. Each of the first and second pull wires can have a proximal end and a distal end. A first gap can exist between the proximal end of the first pull wire liner and the proximal end of the elongated body and a second gap can exist between the proximal end of the second pull wire liner and the proximal end of the elongated body.

Abstract: A prosthetic heart valve system may include a collapsible anchor frame which may include a support frame that has a central portion, and atrial and ventricular portions flared radially outwardly from the central portion. The atrial and ventricular portions may be sized to sandwich or clamp an annulus of the heart valve. An atrial sheet may be coupled to the atrial portion of the support frame and may extend radially inwardly to a central aperture in the atrial sheet, the atrial sheet being formed of a material that is substantially impermeable to blood. The system may include a leaflet support structure, an inflow end of the leaflet support structure coupled to the atrial sheet. The atrial sheet may define an opening positioned radially outside of the leaflet support structure so that blood flowing around an exterior of the leaflet support structure passes through the opening.

Abstract: Electrode assemblies include segmented electrodes disposed on a catheter. The segmented electrodes can be constructed at the tip of the catheter or more proximally located. Tip electrodes can be constructed from an electrically-insulative substrate covered with a conductive material. The conductive material can be deposited on the electrically-insulative substrate to form a single tip electrode or multiple segmented electrodes. In some embodiments the tip electrode can include irrigation flow holes for irrigation. A method of manufacturing a tip electrode comprising a thin layer of conductive material deposited on an electrically-insulative substrate is disclosed. Segmented ring electrodes can be constructed from segmented ring electrodes that can be equally separated around a circumference of a catheter. The segmented ring electrodes can be formed into segmented electrode subassemblies that can then be joined to a catheter shaft.

Abstract: Implantable occlusion devices that include one or more flanges extending from a tubular body are disclosed. The flange or flanges may assist in retention of the device within a vessel, cavity, appendage, etc. At least one flange on the occlusion device may include a concave surface proximate one end of a body. Because of the shape of the flange, e.g., its concavity, the occlusion device may resist dislocation due to e.g., the forces generated within the left atrial appendage during atrial fibrillation.

Abstract: In some embodiments, a prosthetic heart valve system, includes a prosthetic heart valve including a stent, a cuff and a plurality of leaflets, the cuff and the plurality of leaflets forming a valve assembly, and the stent having one or more retention tabs, and a delivery device having an inner shaft and an expandable balloon transitionable between a deflated state and an inflated state, the delivery device having a hub with one or more receivers to accept the one or more retention tabs.

Abstract: According to one aspect of the disclosure, a prosthetic heart valve system includes a prosthetic heart valve including a stent, a cuff and a plurality of leaflets, the cuff and the plurality of leaflets forming a valve assembly, and an expandable balloon having a deflated state and an inflated state, the expandable balloon being configured and arranged to transition the prosthetic heart valve from a collapsed condition to an expanded condition and protect portions of the valve assembly during crimping and delivery.

Abstract: Described herein is a medical device for treating a target site. The medical device includes a proximal end including a disc and a distal end including a lobe. The disc and lobe are connected by a connecting member. The disc includes a proximal surface, a distal surface, and a central surface extending between and connecting the proximal surface and distal surface, wherein the central surface separates the proximal surface from the distal surface by a predetermined depth distance.

Abstract: A collapsible prosthetic heart valve includes a collapsible and expandable stent and a collapsible and expandable valve assembly. The stent has a proximal end and a distal end. A plurality of commissure points is disposed on the stent. The valve assembly is disposed within the stent and includes a plurality of leaflets. Each leaflet has a free edge. An end portion of the free edge of each leaflet is folded and sutured to a corresponding one of the plurality of the commissure points.

Abstract: The present disclosure is directed to embodiments of an occlusive medical device including a frame and at least one closure coupled to the frame. The frame includes a distal annular flange having a radially outer surface and a radially inner surface, a proximal annular flange having a radially outer surface and a radially inner surface, and a waist portion extending between and connecting the distal annular flange to the proximal annular flange. The radially inner surface of the distal annular flange, the waist member, and the radially inner surface of the proximal annular flange define an unobstructed passageway through the frame. The at least one closure is configured to close the passageway to: (i) provide an occlusive effect, and (ii) enable subsequent access through the passageway.

Abstract: A prosthetic heart valve includes a support structure and a valve assembly disposed within the support structure, the valve assembly including a plurality of leaflets. Each leaflet includes a sewing edge and a free edge. The leaflet is formed from a sheet of leaflet material which is processed so that the resulting leaflet has a non-uniform thickness. Various methods may be used to form the leaflet with a non-uniform thickness.

Abstract: A prosthetic heart valve includes a stent having a collapsed condition and an expanded condition. The stent includes a plurality of cells, each cell being formed by a plurality of struts, and a plurality of commissure features. The heart valve further includes a valve assembly secured to the stent and including a cuff and a plurality of leaflets, each leaflet being attached to adjacent commissure features and to the stent struts and/or the cuff.