Abstract: The present disclosure relates to numerous delivery devices and methods for transcatheter prosthetic heart valve loading, deployment and delivery utilizing at least one suture. Disclosed delivery devices utilize improved suture routing methods and configurations that reduce suture tangling and also provide the ability to adjust the prosthetic heart valve expansion and contraction prior to the final release of the prosthetic heart valve from the delivery device.

Abstract: A balloon catheter includes a balloon coupled to a shaft. The shaft includes a proximal perfusion portion disposed proximal of the balloon and a distal perfusion portion disposed distal of the balloon. The proximal and distal perfusion portions each are formed by a respective plurality of wire members woven together to form a respective proximal and distal braided shafts. The plurality of wire members are woven together such that a plurality of perfusion openings are formed between the wire members. The plurality of perfusion openings extend from an outer surface of the respective proximal or distal braided shaft to a lumen of the respective proximal or distal braided shaft. A perfusion lumen extends between the proximal perfusion portion and the distal perfusion portion.

Abstract: A delivery system for delivering a prosthesis includes a sheath, a slide shaft having a threaded outer surface, and a handle. The handle includes an internal spring assembly for selectively engaging and disengaging the handle with the threaded outer surface of the slide shaft. The internal spring assembly includes at least one spring arm, a head coupled to the spring arm and having a circumferentially rounded threaded inner surface, and a ring slidably disposed over the spring arm. When the ring is in a first longitudinal position, the threaded inner surface of the head is spaced apart from the threaded outer surface of the slide shaft. When the ring is in a second longitudinal position, the threaded inner surface of the head is threadedly engaged with the threaded outer surface of the slide shaft. The handle may include a resilient cover to provide the internal spring assembly with a biased or nominal operational position.

Abstract: Delivery devices for a stented prosthetic heart valve. The delivery device includes a spindle, at least one cord, and a covering feature associated with the spindle for selectively covering at least a portion of a stented prosthetic heart valve tethered to the spindle in a delivery state. In some embodiments, the covering feature includes a tip mounted to the spindle. The tip can include an overhang region for selectively covering a portion of the stented prosthetic heart valve. In other embodiments, the tip can include a tip body and a compressible foam bumper. In yet other embodiments, the covering feature includes an outer sheath arranged to selectively cover the stented prosthetic heart valve. The outer sheath can be elastic and stretchable for recapturing a partially expanded prosthesis, for example by including one or more windows covered by a stretchable covering layer.

Abstract: Delivery devices and methods for delivering a stented prosthesis to a target site are disclosed. Disclosed delivery devices include a handle assembly including an actuator, an inner shaft assembly interconnected to the handle assembly, and are configured to releasably retain the stented prosthesis to the delivery device with at least one elongate tension member. The delivery devices further include a tension management device that is configured to limit the amount of tension that can be applied via the actuator to the at least one tension member. Certain embodiments are configured to apply different tension limits to different tension members that are controlled by a one or more actuators. Other various embodiments include one or more tension adjustors to selectively adjust one or more tension limits.

Abstract: Delivery devices for a stented prosthetic heart valve. The delivery device includes a spindle, at least one cord, and a lateral control feature. The cord is tensioned to crimp the prosthesis to a compressed condition for delivery to a target site. Tension is lessened to allow the prosthesis to self-expand. In a tethered and expanded state in which the prosthesis has self-expanded and is connected to the spindle by the cord, the lateral control feature directs the spindle to a prescribed location relative to the prosthesis appropriate for a functional evaluation of the prosthesis. In some embodiments, the spindle is directed to a center of the prosthesis; in other embodiments, the spindle is held at a commissure of the prosthesis. The lateral control features of the present disclosure assume numerous forms.

Abstract: A method of making a method of making a stent includes forming a precursor stent using micro-cladding. The precursor stent includes a plurality of bands made of a first material disposed adjacent to each other and a plurality of connectors connecting each band to an adjacent band. The precursor stent includes a plurality of first connectors configured to remain and a plurality of second connectors made by functionally grading the first material with a second material to create embrittlement. The plurality of second connectors are configured to be removed. The precursor stent is processed to remove the plurality of second connectors without adversely affecting the bands and the plurality of first connectors. The second material may be a radiopaque material.

Abstract: Stented prosthetic heart valves including a stent frame having a plurality of stent frame support structures collectively defining an interior surface, an exterior surface and a plurality of cells. The stented prosthetic heart valve further including a valve structure including valve leaflets disposed within and secured to the stent frame and defining a margin of attachment. The stented prosthetic heart valve including one or both of an outer paravalvular leakage prevention wrap and an inner skirt for supporting the valve leaflets. In various embodiments, the outer wrap is positioned entirely on one side of the margin of attachment. In embodiments including an inner skirt, the outer wrap and the inner skirt are on opposite sides of the margin of attachment such that the inner skirt and the outer wrap do not overlap. In other embodiments, the outer wrap includes a plurality of zones having varying thickness.

Abstract: A delivery system for percutaneously delivering a heart valve prosthesis to a site of a native heart valve includes a delivery catheter and a heart valve prosthesis. The delivery catheter includes an outer sheath, an inner shaft, and an orifice restriction mechanism. The heart valve prosthesis has a valve member and a docking member. When the orifice restriction mechanism is positioned within the docking member within an annulus of the native heart valve, the orifice restriction mechanism temporarily replicates the operation of the native heart valve until the valve member is positioned within the docking member.

Abstract: Tissue compression devices having a tension limiting strap retainer and methods of using the same. The tissue compression devices described herein may include a strap retainer that is attached to a base by an elastic member that is configured to draw the strap retainer towards the base. The tissue compression devices described herein may also include a tension indicator that extends between the base of the tissue compression device and strap retainer. The tension indicator may be configured to limit the travel distance of the strap retainer away from the base in response to forces acting on the strap retainer. The tension indicator may also provide visual feedback to a user of the tension force in a strap to attach the tissue compression device to a patient.

Abstract: An endovascular guide catheter includes a guide tube and a handle. The flexible guide tube has a distal end portion configured to deflect via actuation of a pull wire. The handle is coupled to the guide tube and comprises a steering assembly configured to actuate the pull wire to deflect the distal end portion of the guide tube. The steering assembly can comprise a stationary rack, a gear, a reel, and a slider. The gear engages the rack and the reel is coupled to and configured to rotate with the gear. The pull wire is coupled to the reel such that rotation of the reel causes the pull wire to wind or unwind around the reel. The slider is adapted for translation relative to the rack. Translation of the slider translates the reel relative to the rack and rotation of the gear along the rack rotates the reel.

Abstract: A prosthetic valve including an inner frame, an outer frame, and a connection assembly interconnecting the frames. The inner frame defines an interior volume for receiving a valve structure within the interior volume. The outer frame surrounds the inner frame. The inner and outer frames are each configured to be transitionable between compressed and expanded conditions. The prosthetic heart valve provides a initial deployed state in which the inner and outer frames are in the expanded condition, and a radial shape of the outer frame is adjustable via the connection assembly to a final deployed state. A shape of the outer frame can be adjusted upon implant to enable radial anchoring at the native annulus, while addressing possible non-uniformities of the native annulus and possible anatomical concerns such as LVOT obstruction.

Abstract: A method for stabilizing a cardiac valve annulus is provided. The method includes intravascularly delivering a prosthesis to a region of a cardiac valve, expanding the prosthesis to secure the prosthesis to the region of the cardiac valve, and reducing the inner diameter of the prosthesis to form the region of the cardiac valve into a predefined shape.

Abstract: A stent includes a hollow wire formed into a stent pattern. The hollow wire includes an outer member, a lumen extending longitudinally within the hollow wire, at least one opening extending from an outer surface of the outer member to the lumen, and a surface area component within the hollow wire. The surface area component increases the amount of surface area available for tissue in-growth within the hollow wire. More than one surface area component may be utilized. Each surface area component may be disposed within the lumen or the at least one opening of the hollow wire. A pharmacologically or biologically active agent may be disposed within the lumen.

Abstract: The present disclosure relates to numerous delivery devices and methods for transcatheter prosthetic heart valve loading, deployment and delivery utilizing at least one suture. Disclosed delivery devices utilize improved suture routing methods and configurations that reduce suture tangling and also provide the ability to adjust the prosthetic heart valve expansion and contraction prior to the final release of the prosthetic heart valve from the delivery device.

Abstract: A fenestrated aortic cuff is configured to be delivered endovascularly to a target region, deployed, fastened, and sealed to a vessel wall, e.g., in a neck region of an aortic aneurysm. Example fenestrated cuffs provide a suitable landing zone for a commercially available endograft, which may be, in some cases, positioned below or above the renal arteries in order to complete exclusion of an abdominal aortic aneurysm (AAA) or a thoracic aortic aneurysm (TAA), respectively, from systematic circulation. In some cases, fenestrated cuff function is facilitated and improved by employing active fixation and sealing mechanisms, including, e.g., helical fasteners, which may allow deployment of the fenestrated cuff in short neck regions with limited sealing area.

Abstract: A system for repairing a defective heart valve. The system includes a delivery device, a balloon and a prosthetic heart valve. The delivery device includes an inner shaft assembly and a delivery sheath assembly. The delivery sheath assembly provides a capsule terminating at a distal end. The prosthesis includes a stent carrying a prosthetic valve. In a delivery state, the capsule maintains the prosthesis in a collapsed condition over the inner shaft assembly, and the balloon is in a deflated arrangement radially between the prosthetic heart valve and the capsule. In a deployment state, at least a portion of the balloon and at least a portion of the prosthetic heart valve are distal the capsule. Further, the balloon is inflated and surrounds an exterior of at least a portion of the prosthetic heart valve. The balloon controls self-expansion of the prosthetic heart valve.

Abstract: Delivery devices for delivering a stented prosthesis to a target site are disclosed. Disclosed delivery devices include a handle assembly including an actuator, an inner shaft assembly interconnected to the handle assembly, and are configured to releasably retain the stented prosthesis to the delivery device with at least one elongate tension member. The delivery devices further include a tension management device that is configured to limit the amount of tension that can be applied via the actuator to the at least one tension member. Certain embodiments are configured to apply different tension limits to different tension members that are controlled by a one or more actuators. Other various embodiments include one or more tension adjustors to selectively adjust one or more tension limits.

Abstract: A medical device includes a body defining an exterior surface, and a coating including a therapeutic agent-containing nanoparticle disposed on the exterior surface of the medical device. The nanoparticle may include a brush-arm star polymer. The therapeutic agent may be paclitaxel.

Abstract: Delivery devices for a stented prosthetic heart valve. The delivery device includes a spindle, at least one cord, and a lateral control feature. The cord is tensioned to crimp the prosthesis to a compressed condition for delivery to a target site. Tension is lessened to allow the prosthesis to self-expand. In a tethered and expanded state in which the prosthesis has self-expanded and is connected to the spindle by the cord, the lateral control feature directs the spindle to a prescribed location relative to the prosthesis appropriate for a functional evaluation of the prosthesis. In some embodiments, the spindle is directed to a center of the prosthesis; in other embodiments, the spindle is held at a commissure of the prosthesis. The lateral control features of the present disclosure assume numerous forms.