Abstract: Anchoring assemblies that increase the surface area and/or amount of anchored tissue include a barb anchor, translatably disposed within the opening of an anchor housing, the barb anchor comprising a barb arm, the barb arm including a linear configuration wherein the barb arm is aligned with an axis of the opening and a deflected configuration wherein at least a portion the barb arm is deflected away from a central axis of the opening of the anchor housing.

Abstract: A valve annulus repair system joins anchors at one or both of their proximal and distal ends to construct an implant to reshape the annulus. A removable frame may be used to position the anchors proximate to the annulus and to adjust the shape of the annulus. The frame may support the anchors during deployment of the system, release the anchors during construction of the implant, adjust the shape of the implant (and concomitantly the shape of the reconstructed valve) during an adjustment/cinching process, retain the adjusted shape of the valve annulus while relative anchor positions are secured, and release the anchors to enable the frame to be removed from the deployment site following implant construction. With such a system, a low-profile, flexile annular valve implant with reduced the risks of migration, fracture, embolism and thrombus may be provided.

Abstract: An implantable medical device includes an expandable frame that is moveable between a collapsed configuration for delivery and an expanded configuration for deployment. One or more proximally-facing fixation burrs are secured relative to the expandable frame. One or more distally-facing fixation burrs are secured relative to the expandable frame. The one or more proximally-facing fixation burrs and the one or more distally-facing fixation burrs together provide the implantable medical device with bi-directional stability.

Abstract: A direct visualization catheter includes a handle, a balloon, an elongate shaft, and a camera assembly. The elongate shaft has a proximal end and a distal end opposite the proximal end. The proximal end is coupled to the handle. The distal end is coupled to the balloon and defines a longitudinal axis. The camera assembly is coupled to the distal end of the elongate shaft and is disposed within the balloon. The camera assembly includes a camera and an adjustment mechanism for varying a configuration of the camera relative to the distal end of the elongate shaft between a delivery configuration and a deployed configuration. The camera faces primarily in a radial direction in the delivery configuration and the camera faces primarily in an axial direction in the deployed configuration.

Abstract: An actuator sleeve includes resiliency features that may reduce chronic strain on valve annulus implants. The resiliency features may relate to one or more of a material, a manufacture, a dimension, and/or design attribute of the sleeve. In one aspect the resiliency features may allow deformation of the sleeve at frame interfaces to distribute forces to reduce the frame fatigue.

Abstract: Medical devices and methods for making and using medical devices are disclosed. An example medical device may include a guide extension catheter. The guide extension catheter may include a proximal member having a proximal end, a distal end, and a proximal diameter. The guide extension catheter may additionally include a collar member attached to the distal end of the proximal member, the collar member comprising a base portion and one or more ribs connected to the base portion and extending distally away from the base portion. In still some additional embodiments, the guide extension catheter may further include a distal sheath member attached to the collar member, the distal sheath member having a distal diameter larger than the proximal diameter.

Abstract: Anchoring assemblies that increase the surface area and/or amount of anchored tissue include a barb anchor, translatably disposed within the opening of an anchor housing, the barb anchor comprising a barb arm, the barb arm including a linear configuration wherein the barb arm is aligned with an axis of the opening and a deflected configuration wherein at least a portion the barb arm is deflected away from a central axis of the opening of the anchor housing.

Abstract: An example occlusive implant is disclosed. The example occlusive implant includes an expandable framework configured to shift between a first configuration and a second expanded configuration, an occlusive member disposed along at least a portion of an outer surface of the expandable framework and a resilient member coupled to the occlusive member. Further, the resilient member is configured to keep the occlusive member taut against an outer surface of the expandable member in both the first configuration and the second configuration.

Abstract: Medical devices and methods for making and using medical devices are disclosed. An example medical device may include an elongate shaft having a proximal end region and a distal end region. A first lumen may be defined in the shaft. A second lumen may be defined in the shaft. The distal end region may include a common lumen region in fluid communication with the first lumen and the second lumen. A deflectable member may be disposed within the shaft. The deflectable member may be designed to shift between a first configuration where the deflectable member directs a first medical device disposed within the common lumen region into the first lumen and a second configuration where the deflectable member allows a second medical device to move between the common lumen region and the second lumen.

Abstract: An example introducer is disclosed. An example introducer includes an inner liner including a lumen, a distal region and at least one folded portion extending along the distal region. The introducer also includes a reinforcing member having a length and including at least one spine extending along the length of the reinforcing member. The introducer also includes a sheath disposed along at least a portion of the introducer, wherein the sheath includes at least one perforation, wherein material adjacent to the at least one folded portion is removed from a distal portion of the introducer to form a tip region. The introducer also includes a tip member disposed along the tip region.

Abstract: Various embodiments of an implant delivery systems including at least one removable actuator to reshape a valve annulus are described. The systems may use the removable actuator to customize annular reshaping at a treatment site and withdraw the actuator from the treatment site following custom reshaping to provide a low profile annuloplasty implant.

Abstract: A delivery system is provided for delivering an expandable medical device. The delivery system includes a catheter shaft, a proximal stop coupled to the catheter shaft, an inner tube coupled to the proximal stop and extending distally therefrom, a distal stop coupled to the inner tube, and a balloon disposed over the distal stop, the inner tube, and the proximal stop. The inner tube defines an inflation lumen and has a plurality of openings extending through a sidewall of the inner tube into the inflation lumen. The distal stop includes at least one channel extending through a sidewall of the distal stop into the lumen. The distal stop is configured to allow inflation fluid to flow through the inner tube and the at least one channel into a distal region of the balloon.

Abstract: A delivery system for an expandable prosthetic heart valve is provided. The delivery system includes an elongate inner member, a distal stop and a proximal stop both disposed on the elongate inner member. At least one of the proximal and distal stops is fixed to the elongate inner member. The delivery system also includes a flexible member disposed around the elongate inner member and having a distal end, a central region, and a proximal end, and an inflatable balloon disposed over the flexible member. The flexible member is configured such that when a heart valve is crimped onto the central region, the central region compresses and proximal and distal regions of the flexible member expand radially to prevent axial movement of the valve.

Abstract: Medical devices and methods for making and using medical devices are disclosed. An example medical device may include a guide extension catheter. The guide extension catheter may include a proximal member having a proximal end, a distal end, and a proximal diameter. The guide extension catheter may additionally include a collar member attached to the distal end of the proximal member, the collar member comprising a base portion and one or more ribs connected to the base portion and extending distally away from the base portion. In still some additional embodiments, the guide extension catheter may further include a distal sheath member attached to the collar member, the distal sheath member having a distal diameter larger than the proximal diameter.

Abstract: An example introducer is disclosed. An example introducer includes an inner liner including a lumen, a distal region and at least one folded portion extending along the distal region. The introducer also includes a reinforcing member having a length and including at least one spine extending along the length of the reinforcing member. The introducer also includes a sheath disposed along at least a portion of the introducer, wherein the sheath includes at least one perforation, wherein material adjacent to the at least one folded portion is removed from a distal portion of the introducer to form a tip region. The introducer also includes a tip member disposed along the tip region.

Abstract: Medical devices and methods for making and using medical devices are disclosed. An example medical device may include an elongate shaft having a proximal end region and a distal end region. A first lumen may be defined in the shaft. A second lumen may be defined in the shaft. The distal end region may include a common lumen region in fluid communication with the first lumen and the second lumen. A deflectable member may be disposed within the shaft. The deflectable member may be designed to shift between a first configuration where the deflectable member directs a first medical device disposed within the common lumen region into the first lumen and a second configuration where the deflectable member allows a second medical device to move between the common lumen region and the second lumen.

Abstract: A low profile implant, system and method of deployment includes a frame comprising an elongate body having ends that overlap to form an annular configuration of the frame. A circumference of the frame may be modified by varying an extent of the overlap between the ends of the elongate body. The elongate structure may extend through a sleeve of a number of respective anchor housings of the implant along a first axis, and anchors may be deployed through bores in the anchor housings along a second axis to secure the anchor housings to tissue. The implant may be deployed about and anchored to a valve annulus, and the circumference of the frame, and associated anchored tissue, may be adjusted to reconfigure the valve annulus.

Abstract: Various embodiments of an implant delivery systems including at least one removable actuator to reshape a valve annulus are described. The systems may use the removable actuator to customize annular reshaping at a treatment site and withdraw the actuator from the treatment site following custom reshaping to provide a low profile annuloplasty implant.

Abstract: Devices, systems, and methods for delivering various implantable devices, such as heart valve implants, with the use of a steerable imaging element are described. An imaging element is positioned adjacent the implantable device and implant site, a relationship between the implantable device and the implant site is visualized and/or imaged, and the implantable device is anchored and/or adjusted with reference to the visualization and/or imaging thereof.

Abstract: An implantable device delivered and deployed with a visualization and/or imaging system. An imaging element is positioned on a distal end of a flexible elongate member of the visualization/imaging system. The distal end with the imaging element is positioned adjacent the implant and/or the implant site, and moved relative to the longitudinal axis of the flexible elongate member to adjust the viewing field of the imaging device.