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 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 method of closing a patent foramen ovale (PFO) including a septum primum and septum secundum is implemented using a suture device including an operational shaft housing an anchor assembly, a needle assembly, and a suture. The method includes advancing an end of the operational shaft to a proximal side of the PFO, positioning a distal portion of the end of the operational shaft on a distal side of the PFO, and actuating the anchor assembly to deploy the anchor assembly on the distal side of the PFO. The method also includes actuating the needle assembly on the proximal side of the PFO to deploy the needle assembly through the PFO and the anchor assembly, thereby deploying the suture through the PFO. The method further includes retracting the anchor assembly into the operational shaft, and withdrawing the distal portion of the operational shaft from the PFO, leaving the deployed suture.

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 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: 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 catheter pump includes a cannula and an impeller system. The cannula has an inlet zone with a first maximum outer diameter, an outlet zone with a second maximum outer diameter and a blood flow channel extending between the inlet zone and the outlet zone. The first maximum outer diameter is greater than the second maximum outer diameter, and the impeller system has a rotatable impeller body operable to convey blood from the inlet zone to the outlet zone. The impeller body may be axially spaced from the cannula in a separated position.

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 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: 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: Apparatus, systems, and methods for percutaneous valve replacement and/or augmentation are provided. The apparatus includes a valve having a valve frame, a valve leaflet coupled to the valve frame, and a leaflet transition member coupled to the valve leaflet. The valve leaflet and leaflet transition member can transition from a first position where the valve leaflet and leaflet frame are at least partially outside a lumen of the valve frame to a second position where the valve leaflet and the leaflet transition member are within the lumen of the valve frame.

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: An introducer hub assembly, such as an introducer hub assembly of a leadless cardiac pacemaker, including a hemostatic seal having a cross-slit configuration, is described. The hemostatic seal can be retained between a hub cap and an introducer hub. The hemostatic seal includes a first section having first slits intersecting along a longitudinal axis of the introducer hub, and a second section having second slits intersecting along the longitudinal axis. The first slits are angularly offset relative to the second slits to reduce a likelihood that fluid will leak directly through the seal. Other embodiments are also described and claimed.

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 medical device including stabilizing members and a delivery system including the same are described herein. The medical device includes a device body and the stabilizing members coupled thereto. Each stabilizing member has a backing portion coupled to the device body and an engagement portion extending from an outward face of the backing portion. The engagement portion is configured to extend radially outward from the device body. The medical device also includes one or more features configured to control at least one of tissue penetration depth of the at least one engagement portion, extension of the stabilizing member from the device body, and tissue engagement of the at least one engagement portion. The delivery system includes the medical device and a delivery sheath configured to retain and recapture the medical device during deployment to a target site.

Abstract: A medical device includes a device frame, including a proximal portion and a distal portion and configured to selectively transition between a collapsed configuration and an expanded configuration. The medical device also includes at least one cover, wherein at least one cover is coupled to at least one of the proximal and distal portions.

Abstract: An introducer hub assembly, such as an introducer hub assembly of a leadless cardiac pacemaker, including a hemostatic seal having a cross-slit configuration, is described. The hemostatic seal can be retained between a hub cap and an introducer hub. The hemostatic seal includes a first section having first slits intersecting along a longitudinal axis of the introducer hub, and a second section having second slits intersecting along the longitudinal axis. The first slits are angularly offset relative to the second slits to reduce a likelihood that fluid will leak directly through the seal. Other embodiments are also described and claimed.

Abstract: Described herein is a medical device including a medical device including a device body and a plurality of extensions. The device body includes a first side, a second side, and a plurality of expandable cells. The plurality of expandable cells have a proximal edge and a distal edge. The plurality of expandable cells extends laterally between and connects the first and second sides. The plurality of extensions extend longitudinally from each of the first and second sides. A first plurality of extensions extend proximally from a proximal end of each side to beyond the proximal edge and a second plurality of extensions extend distally from a distal end of each side to beyond the distal edge. The first and second pluralities of extensions have coiled ends.

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.