Abstract: According to one aspect of the disclosure, a delivery device may include a handle, a catheter sheath extending distally from the handle, and a hemostasis valve positioned within the handle. The hemostasis valve may be located proximal to the catheter sheath and distal to a proximal end of the handle. The delivery device may also include a hemostasis bypass assembly coupled to the handle. The hemostasis bypass assembly may include a bypass tube coupled to an actuator. The actuator may be configured to be transitioned between a first condition in which a distal end of the bypass tube is positioned proximal to the hemostasis valve and the hemostasis valve is closed, and a second condition in which the distal end of the bypass tube traverses the hemostasis valve and the hemostasis valve is opened.

Abstract: A delivery cable for delivering a medical device and a delivery device including the same are described herein. The delivery cable includes a flexible inner core, an outer coil surrounding at least a portion of the flexible inner core, and a pull wire disposed between the flexible inner core and the outer coil, the pull wire configured to deflect a distal deflectable portion of the delivery cable upon manipulation thereof. Methods of making the delivery cable and methods of using the delivery cable to deploy a medical device are also described herein.

Abstract: Described herein is a medical device including a frame having proximal and distal ends. The frame includes a proximal disc at the proximal end, a distal disc at the distal end, and a connecting segment extending between the proximal end and the distal end and connecting the proximal and distal discs. Each of the proximal and distal discs includes a respective plurality of lobes. Each lobe is defined by a peripheral strut. The medical device also includes at least one patch. The at least one patch is coupled to at least one of the proximal and distal discs of the frame.

Abstract: A prosthetic heart valve system may include a prosthetic heart valve, a tether having a first end configured to connect to the prosthetic heart valve and a second end, and a collapsible and expandable anchor. The anchor includes a center rim configured to couple to the second end of the tether. The anchor further includes a plurality of struts extending radially outward from the center rim forming an inner dome that is concave toward a heart when the anchor is in a resting configuration implanted on an apex of the heart. The anchor further includes a plurality of wings extending radially outward from the struts.

Abstract: Systems and methods for separating native heart valve leaflets attached together by a fixation device. The system has elongate shaft including a proximal end portion, a distal end portion and a longitudinal axis extending therebetween. The elongate shaft is configured for transvascular delivery of the distal end portion to a native heart valve. A balloon is disposed at the distal end portion of the elongate shaft, and the balloon is inflatable from a collapsed condition to an inflated condition. At least one snare lumen extends along at least a portion of the balloon, the at least one snare lumen having an exit port defined therein. A snare is deployable through the exit port from a delivery position within the at least one snare lumen to an extended position extending beyond the exit port. The snare in the extended position is configured to capture the fixation device.

Abstract: A medical device includes a first end, a second end, and a central segment proximate a middle of the medical device and about which the medical device is symmetrical. The medical device also includes a pair of inner reverse bends spaced from the central segment by a first body plane extending from the central segment to the pair of inner reverse bends in a first longitudinal direction, and a pair of outer reverse bends. The outer reverse bends are spaced from the pair of inner reverse bends by a second body plane extending from the pair of inner reverse bends to the pair of outer reverse bends in a second, opposite longitudinal direction, and the outer reverse bends are spaced from the first and second ends of the medical device by a third body plane extending in the first direction from the outer reverse bends to the first and second ends.

Abstract: A prosthetic heart valve may include a valve portion, a tether connected to the valve portion, and an anchor for connecting the tether to the wall of the heart. The prosthetic heart valve system includes a collapsible and expandable stent, a plurality of prosthetic leaflets coupled to the stent, a collapsible anchor, and a tether configured to couple the stent to the anchor, wherein the collapsible anchor includes a flexible frame body defining a plurality of collapsible cells, each cell having at least one side shared with a neighboring cell, a center adjoining point defined by the cells formed in the flexible frame body, the center adjoining point configured to receive the tether, and a first tip end and a second tip end defining a major axis of the flexible frame body, the major axis passing through the center adjoining point.

Abstract: A medical device including a locking mechanism and a method including activating the locking mechanism are described herein. The medical device includes distal and proximal disc portions and a locking mechanism. The locking mechanism is configured to pull and maintain the distal and proximal disc portions toward each other when the medical device is deployed in an expanded configuration.

Abstract: A delivery cable for delivering a medical device and a delivery device including the same are described herein. The delivery cable includes a flexible inner core, an outer coil surrounding at least a portion of the flexible inner core, and a pull wire disposed between the flexible inner core and the outer coil, the pull wire configured to deflect a distal deflectable portion of the delivery cable upon manipulation thereof. Methods of making the delivery cable and methods of using the delivery cable to deploy a medical device are also described herein.

Abstract: A delivery device for a prosthetic heart valve includes a catheter assembly and an operating handle. The catheter assembly may include an inner shaft around which a compartment for the heart valve is defined, and a distal sheath having proximal and distal segments configured to enclose the compartment. The handle may include a first lead screw coupled to the proximal segment and a second lead screw coupled to the distal segment. Actuation of the first lead screw operates to move the proximal segment of the distal sheath proximally and actuation of the second lead screw operates to move the distal segment of the distal sheath distally to uncover the compartment and deploy the heart valve.

Abstract: A delivery device for a prosthetic heart valve includes a catheter assembly and an operating handle. The catheter assembly may include an inner shaft around which a compartment for the heart valve is defined, and a distal sheath having proximal and distal segments configured to enclose the compartment. The handle may include a first lead screw coupled to the proximal segment and a second lead screw coupled to the distal segment. Actuation of the first lead screw operates to move the proximal segment of the distal sheath proximally and actuation of the second lead screw operates to move the distal segment of the distal sheath distally to uncover the compartment and deploy the heart valve.