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 hub assembly for connection to a medical device. The hub assembly may comprises an outer component having a proximal end, a distal end, and a cavity extending from the proximal end to the distal end. The hub assembly may further include an insert having a proximal end, a distal end, and a lumen extending from the proximal end to the distal end positioned at least in part within the cavity of the outer component. The insert may have a lumen extending from the proximal end to the distal end thereof. The outer component may be formed from a first material and the insert may be formed from a second material different from the first material.

Abstract: An example medical device for occluding the left atrial appendage includes an expandable member having a first end region, a second end region and an inflation cavity. The medical device also includes a plurality of spine members coupled to the expandable member, the plurality of spine members spaced circumferentially around an outer surface of the expandable member. Additionally, the medical device includes a valve member extending at least partially into the inflation cavity, wherein the plurality of spine members are configured to position the medical device within an opening of the left atrial appendage and wherein the expandable member is configured to expand and seal the opening of the left atrial appendage.

Abstract: An implant for occluding a left atrial appendage may include an expandable framework configured to shift between a collapsed configuration and an expanded configuration, wherein the expandable framework includes an attachment point configured to secure the expandable framework to a delivery device, and an occlusive element disposed on a proximal portion of the expandable framework, wherein the occlusive element covers the attachment point.

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: 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 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: Described herein are delivery devices and systems for delivering a detachable medical device and various associated methods of using such devices and systems.

Abstract: Systems for nerve and tissue modulation are disclosed. An example system may include an intravascular nerve modulation system including an elongated shaft having a proximal end region and a distal end region. The system may further include one or more ablation electrodes affixed to the distal end region of the elongated shaft. One or more ground pad electrodes may be provided and connected to a processor configured to modulate the impedance of each circuit completed between the ablation electrodes and the ground pads.

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 a tubular member including an inner layer and an outer layer, the inner layer having an inner surface, an outer surface and wall extending therebetween. The outer layer is disposed along the outer surface of the inner layer. The inner layer includes a plurality of longitudinal channels extending radially outward from the inner surface. Each channel of the plurality of channels has a circumferential width. Further, the tubular member is designed to shift from an unexpanded configuration to an expanded configuration, wherein the width of each channel increases as the tubular member shifts from the unexpanded configuration to the expanded configuration.

Abstract: An atherectomy device is disclosed herein. The atherectomy device includes a first drive shaft, a second drive shaft, a handle assembly, and a cutting member. The first drive shaft extends distally from the handle assembly and includes the cutting member mounted on a distal end region of the first drive shaft. The second drive shaft extends distally from the handle assembly to a distal end of the second drive shaft such that both the first and the second drive shafts are rotatable relative to the handle assembly, and the first drive shaft is rotatable independent of the second drive shaft.

Abstract: Catheter systems and methods for determining blood flow rates based on temperature measurements by thermodilution. The catheter may include a fluid lumen defined between inner and outer tubular members for delivering an indicator fluid, and a guidewire lumen defined by the inner tubular member. The catheter may include fluid infusion openings at the distal end region of the outer tubular member configured to permit the indicator fluid to exit the catheter from the fluid lumen, and a fluid hole located at the distal end region of the inner tubular member configured to permit the indicator fluid to pass from the fluid lumen into the guidewire lumen. A temperature sensor positioned on a guidewire may be positioned within the guidewire lumen to measure the temperature of the indicator fluid entering the guidewire lumen through the fluid hole. A blood flow rate may be calculated based on the measured temperature.

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 implant for occluding a left atrial appendage may include an expandable framework configured to shift between a collapsed configuration and an expanded configuration, an occlusive element disposed on the expandable framework, and a sealing member spaced apart proximally from the expandable framework by a gap distance. A system for occluding a left atrial appendage may further include a delivery sheath and a core wire releasably secured to the implant. A method for occluding a left atrial appendage may include advancing the implant to the left atrial appendage, deploying the expandable framework within the left atrial appendage, shifting the expandable framework into the expanded configuration within the left atrial appendage, and deploying the sealing member proximate an ostium of the left atrial appendage.

Abstract: Medical devices and methods for making and using medical devices are disclosed. An example medical device may include a renal nerve modulation device. The renal nerve modulation device may include an elongate shaft. A balloon may be coupled to the shaft. The balloon may have a hydrophilic electrode region. A sensor may be coupled to the balloon and may be disposed adjacent to the hydrophilic electrode region. An electrode may be coupled to the catheter shaft and may be disposed within the balloon.

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: Catheters with weeping balloons can be used for various medical purposes. For example, in some embodiments provided herein weeping balloons are used for catheter visualization devices. In some embodiments, weeping balloons are used to deliver therapeutic agents. Weeping balloons can include openings of a selected size and shape through which a fluid gradually flows or “weeps.” The design of the openings can affect performance characteristics such as, but not limited to, fluid flow rate, tear resistance, and mitigation of counter-flow.

Abstract: The present invention provides systems and methods for accurately delivering embolic coils within a body lumen of a patient, as well as recapturing deployed embolic coils for removal or repositioning. In various embodiments, an embolic coil delivery system may include an elongate sheath with a lumen extending therethrough. An elongate shaft may be slidably disposed within the sheath. The shaft may comprise a split-distal end that defines an aperture. The split-distal end may be moveable between a contracted configuration and an expanded configuration. An embolic coil may include a proximal ball-tip that may be reversibly disposed within the aperture of the split-distal end.

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.