Abstract: Systems and methods for preparing and loading a collapsible cardiac implant into a delivery system is provided, and includes a stent crimper with an alignment mechanism and a transfer tube to reduce the risk of damage to the delivery system during loading.

Abstract: A replacement heart valve comprises one or more stent frame features, including inset barbs, ring attachment structures or attachment tabs.

Abstract: Prosthetic mitral valves and their methods of manufacture and use.

Abstract: An intravascular device delivery system has an elongated member, a guidewire receiving member, and a distal cap longitudinally fixed to a guidewire receiving member. The distal cap includes an insert having an elongate member, a rim member radially separated from the elongate member, and a wall member supporting the rim member, the wall member being disposed between the rim member and the elongate member.

Abstract: A system for delivery of cardiac implants includes a catheter having a handle assembly including a cable control assembly. The handle assembly further includes a tubular body assembly extending distally from the handle assembly and deflectable by operation of the cable control assembly. The system also includes a robot having a linear displacement platform and a carriage coupled to the linear displacement platform. The carriage includes a drive motor assembly and is at least one of linearly displaceable along the linear displacement platform and rotatable relative to the linear displacement platform. The handle assembly is coupled to the carriage such that the cable control assembly interfaces with the drive motor assembly of the carriage to facilitate operation of the cable control assembly by the robot.

Abstract: A delivery device includes a handle, a central elongate member extending from the handle, a sheath configured to slide over and relative to the central elongate member, a distal tether retainer at a distal end of the central elongate member, a proximal tether restraining mechanism positioned along the central elongate member distal of the handle and proximal of the distal tether retainer, and a plurality of tethers. The tethers are configured to extend from the proximal tether restraining mechanism to the distal tether retainer.

Abstract: A loading device configured to radially collapse an expandable medical implant may include an operating handle having an opening therein extending along a longitudinal axis, a native sheath coupled to the operating handle and partially extending into the opening, such that the native sheath is configured to translate relative to the operating handle parallel to the longitudinal axis, a removable sheath removably coupled to the native sheath, an actuation rod extending parallel to the longitudinal axis at least partially through the opening, a lumen of the native sheath, and a lumen of the removable sheath, a distal end of the actuation rod being configured to be removably coupled to the expandable medical implant, and a first control element movable relative to the operating handle and coupled to the native sheath, the first control element being configured to translate the native sheath and the removable sheath relative to the operating handle.

Abstract: A delivery device includes a handle, a central elongate member extending from the handle, a sheath configured to slide over and relative to the central elongate member, a distal tether retainer at a distal end of the central elongate member, a proximal tether restraining mechanism positioned along the central elongate member distal of the handle and proximal of the distal tether retainer, and a plurality of tethers. The tethers are configured to extend from the proximal tether restraining mechanism to the distal tether retainer.

Abstract: A system for delivery of cardiac implants includes a catheter having a handle assembly including a cable control assembly. The handle assembly further includes a tubular body assembly extending distally from the handle assembly and deflectable by operation of the cable control assembly. The system also includes a robot having a linear displacement platform and a carriage coupled to the linear displacement platform. The carriage includes a drive motor assembly and is at least one of linearly displaceable along the linear displacement platform and rotatable relative to the linear displacement platform. The handle assembly is coupled to the carriage such that the cable control assembly interfaces with the drive motor assembly of the carriage to facilitate operation of the cable control assembly by the robot.

Abstract: A prosthetic valve delivery device includes a handle and a delivery catheter. The delivery catheter includes a central elongate member extending from the handle and a proximal sheath configured to slide over and relative to the central elongate member. The proximal sheath is connected to a hollow helical strand, and the hollow helical strand is configured to rotate to retract the proximal sheath and expose at least a portion of the prosthetic valve.

Abstract: A delivery device includes a central elongate structure including an annular member at the distal end, a sheath, a plurality of tethers extending through the central elongate structure, a handle, and a control on the handle. The handle is connected to the elongate structure, the sheath, and the plurality of tethers. The control is configured to move the sheath proximally and distally over the central elongate structure. The annular member includes a plurality of pockets extending radially therearound. Each tether includes a feature on a distal end thereof configured to fit within a pocket of the plurality of pockets to hold the tethers in place.

Abstract: A prosthetic mitral valve includes an anchor assembly, an annular strut frame, and a plurality of replacement leaflets secured to the annular strut frame. The anchor assembly includes a ventricular anchor, an atrial anchor, and a central portion therebetween. The annular strut frame is disposed radially within the anchor assembly. An atrial end of the annular strut frame is attached to the anchor assembly such that a ventricular end of the annular strut frame is spaced away from the anchor assembly.

Abstract: A delivery device includes a central elongate structure, a sheath, a plurality of tethers extending through the central elongate structure configured to hold a cardiac valve, a cutting mechanism, a handle, and a control. The sheath is configured to slide over the central elongate structure. The cutting mechanism is configured to cut the tethers upon activation to release the cardiac valve. The handle is connected to the central elongate structure. The control on the handle is configured to activate the cutting mechanism.

Abstract: A delivery device includes a handle, a central elongate member extending from the handle, a sheath configured to slide over and relative to the central elongate member, a distal tether retainer at a distal end of the central elongate member, a proximal tether restraining mechanism positioned along the central elongate member distal of the handle and proximal of the distal tether retainer, and a plurality of tethers. The tethers are configured to extend from the proximal tether restraining mechanism to the distal tether retainer.

Abstract: A loading device configured to radially collapse an expandable medical implant may include an operating handle having an opening therein extending along a longitudinal axis, a native sheath coupled to the operating handle and partially extending into the opening, such that the native sheath is configured to translate relative to the operating handle parallel to the longitudinal axis, a removable sheath removably coupled to the native sheath, an actuation rod extending parallel to the longitudinal axis at least partially through the opening, a lumen of the native sheath, and a lumen of the removable sheath, a distal end of the actuation rod being configured to be removably coupled to the expandable medical implant, and a first control element movable relative to the operating handle and coupled to the native sheath, the first control element being configured to translate the native sheath and the removable sheath relative to the operating handle.

Abstract: Prosthetic mitral valves and their methods of manufacture and use.

Abstract: A loading device configured to radially collapse an expandable medical implant may include an operating handle having an opening therein extending along a longitudinal axis, a native sheath coupled to the operating handle and partially extending into the opening, such that the native sheath is configured to translate relative to the operating handle parallel to the longitudinal axis, a removable sheath removably coupled to the native sheath, an actuation rod extending parallel to the longitudinal axis at least partially through the opening, a lumen of the native sheath, and a lumen of the removable sheath, a distal end of the actuation rod being configured to be removably coupled to the expandable medical implant, and a first control element movable relative to the operating handle and coupled to the native sheath, the first control element being configured to translate the native sheath and the removable sheath relative to the operating handle.

Abstract: A delivery device includes a handle, a central elongate member extending from the handle, a sheath configured to slide over and relative to the central elongate member, a distal tether retainer at a distal end of the central elongate member, a proximal tether restraining mechanism positioned along the central elongate member distal of the handle and proximal of the distal tether retainer, and a plurality of tethers. The tethers are configured to extend from the proximal tether restraining mechanism to the distal tether retainer.

Abstract: Prosthetic mitral valves and their methods of manufacture and use.

Abstract: A delivery device includes a central elongate structure including an annular member at the distal end, a sheath, a plurality of tethers extending through the central elongate structure, a handle, and a control on the handle. The handle is connected to the elongate structure, the sheath, and the plurality of tethers. The control is configured to move the sheath proximally and distally over the central elongate structure. The annular member includes a plurality of pockets extending radially therearound. Each tether includes a feature on a distal end thereof configured to fit within a pocket of the plurality of pockets to hold the tethers in place.