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: Disclosed herein is an inflow cannula for an implantable blood pump assembly. The inflow cannula includes a tubular body that extends from a proximal end to a distal end. The tubular body includes a proximal portion adapted for connection to a pump housing, and a distal portion adapted for positioning within an opening formed in a heart. The inflow cannula further includes an expandable sleeve coupled to an exterior surface of the distal portion. The sleeve has a first portion coupled to the distal portion of the tubular body, and a second portion extending from the distal end of the tubular body. The second portion is deployable from a first, stored configuration to a second, deployed configuration in which the second portion expands radially to engage and conform to an endocardial surface of the heart.

Abstract: Disclosed herein is a catheter pump that includes an expandable cannula and an impeller system. The expandable cannula defines a blood flow channel and includes an impeller blade zone, an inlet zone, and an outlet zone. The catheter pump further includes an impeller system including an impeller body, the impeller system movable relative to the expandable cannula along a longitudinal axis of the catheter pump. The catheter pump is selectively transitionable between a separated configuration in which the impeller body is axially spaced from the expandable cannula along the longitudinal axis, and an operational configuration in which the impeller body is positioned within the impeller blade zone of the expandable cannula.

Abstract: Systems and methods are provided for implanting an implantable cardiac monitor. An insertion system includes an implantable cardiac monitor (ICM). An insertion housing comprises a passage extending from a first end of the insertion housing to a second end of the insertion housing. The passage configured to receive the obturator and a receptacle in communication with the passage and an external environment. The receptacle configured to receive the ICM. An obturator is configured to move within the passage when the obturator is moved relative to the insertion housing. The obturator has a channel forming section at a distal end thereof and a motion limiter is provided on at least one of the shaft and the insertion housing.

Abstract: A tether system for securing a prosthetic heart valve within a patient, the tether system comprising a tether defining a longitudinal axis, and a deformable element coupled to the tether, the deformable element having a first deformed shape in a first condition of the deformable element, and having a second substantially straight shape in a second condition of the deformable element so that, when the deformable element is in the second condition, the deformable element extends in a direction along the longitudinal axis.

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 patent foramen ovale (PFO) tunnel filler medical device including device anchors coupled to and extending outwardly from a filler portion of a device frame that has a generally planar shape configured to fill a PFO tunnel, and a delivery system including the same are described herein. The medical device includes a fabric layer and the device anchors are configured to extend outwardly from the device frame.

Abstract: A prosthetic heart valve for replacing a native valve includes a collapsible and expandable stent having a proximal end and a distal end, and a valve assembly including a plurality of leaflets, the valve assembly being disposed within the stent. The heart valve further includes a first plurality of elongated legs coupled to the stent and transitionable from an extended configuration to a relaxed configuration. A first sealing portion connected to the first plurality of legs forms a sealing structure when the legs transition to the relaxed configuration to reduce perivalvular leakage between the implanted valve and surrounding tissue.

Abstract: A prosthetic heart valve may include an expandable stent, a cuff attached to an annulus section of the stent, and a plurality of leaflets disposed within an interior region of the stent and attached to at least one of the cuff or the stent. The stent may have a plurality of cells connected to one another in a plurality of annular rows around the stent. The leaflets together may have a coapted position occluding the interior region of the stent and an open position in which the interior region is not occluded. Each leaflet may include a primary leaflet material, as well as features that reinforce specific regions of the leaflet.

Abstract: A valve and tether fixation mechanism includes an anchor, a tether, and a prosthetic heart valve. The anchor may be for anchoring a prosthetic heart valve in a native heart valve. The tether may have a distal end coupled to the anchor. The tether may extend proximally from the anchor and connect to a tensioning mechanism. The prosthetic valve may be configured to translate along the tether. The valve may have a tether connecting portion configured to allow for adjustment of the tension in the tether and affix the prosthetic valve to the tether at a desired tension.

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 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 prosthetic heart valve includes a non-collapsible annular frame extending between an inflow edge and an outflow edge, the frame having a plurality of annularly spaced commissure posts adjacent the outflow edge. A valve assembly including a plurality of leaflets is connected to the frame. The frame includes a weakened portion such that the frame is expandable from an initial condition having a first diameter to an expanded condition having a second diameter larger than the first diameter when a radially outward force is applied to an inner surface of the frame. A stabilizing strut may be positioned adjacent the weakened portion to reinforce the frame. The prosthetic heart valve may include an expandable ring positioned around the expandable frame.

Abstract: A delivery system for an intracorporeal device includes a sheath defining one or more lumens shaped to receive a delivery catheter or shaft and a guidewire. The system may include a delivery shaft having a distal coupling feature adapted to releasably couple with a proximal coupling feature of the intracorporeal device. The delivery system may further include a hub through which the delivery shaft and guidewire are passed. The delivery shaft may be coupled to a feature, such as a knob, that enables manipulation of the delivery shaft to decouple the distal fixation feature from the proximal fixation feature of the intracorporeal device in order to deploy the intracorporeal device within a patient.

Abstract: A medical tool includes a rotation mechanism that further includes a warning feature. The warning feature provides an indication when the rotation mechanism has achieved a number of rotations.

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: Disclosed herein is a catheter pump that includes an expandable cannula and an impeller system. The expandable cannula defines a blood flow channel and includes an impeller blade zone, an inlet zone, and an outlet zone. The catheter pump further includes an impeller system including an impeller body, the impeller system movable relative to the expandable cannula along a longitudinal axis of the catheter pump. The catheter pump is selectively transitionable between a separated configuration in which the impeller body is axially spaced from the expandable cannula along the longitudinal axis, and an operational configuration in which the impeller body is positioned within the impeller blade zone of the expandable cannula.

Abstract: A delivery system for an intracorporeal device includes a sheath defining one or more lumens shaped to receive a delivery catheter or shaft and a guidewire. The system may include a delivery shaft having a distal coupling feature adapted to releasably couple with a proximal coupling feature of the intracorporeal device. The delivery system may further include a hub through which the delivery shaft and guidewire are passed. The delivery shaft may be coupled to a feature, such as a knob, that enables manipulation of the delivery shaft to decouple the distal fixation feature from the proximal fixation feature of the intracorporeal device in order to deploy the intracorporeal device within a patient.

Abstract: A medical tool includes a rotation mechanism that further includes a warning feature. The warning feature provides an indication when the rotation mechanism has achieved a number of rotations.

Abstract: A prosthetic heart valve includes a collapsible and expandable stent having an outflow end and an inflow end, a plurality of commissure features attached to the stent, a plurality of anchoring features disposed on legs of the stent, the plurality of anchoring features being coupleable to a delivery device for repositioning, and a valve assembly disposed within the stent. The anchoring features may be configured to attach to heart tissue to help secure the prosthetic heart valve in an operating position.