Abstract: A guide sheath device with an integrated stabilization wire is provided. The guide sheath device includes an elongate member having a proximal and distal end and a lumen there between and a stabilization wire integrated to the elongate member. The guide sheath is configured to access the lower vasculature via a contralateral percutaneous access. The stabilization wire is configured to exit the vasculature at an ipsilateral percutaneous access and be locked in place at the exit. The proximal end of the guide sheath and the distal end of the stabilization wire being accessible outside the vasculature enable stabilization of the stabilization wire and the guide sheath. The stabilization enables stabilization of procedural catheters and instruments as they access the site of a procedure within the lower vasculature.

Abstract: Implant engagement mechanisms are disclosed for maintaining engagement with a stent until it has been fully deployed and expanded from a catheter or sheath. The apparatus, method and system involving these engagement mechanisms allow a physician to withdraw or retract a sheath prior to full deployment, thereby allowing for redeployment of the stent at a more desirable position.

Abstract: A system for treating a bifurcation includes first and second delivery catheters. The first catheter has a first shaft, a first expandable member adjacent the distal end of the first shaft, an auxiliary expandable member disposed under the first expandable member, and a first radially expandable stent disposed over both the first expandable member and the auxiliary expandable member. The second delivery catheter has a second shaft, and a second expandable member adjacent the distal end of the second shaft. A portion of the second catheter is disposed under a portion of the first stent, and a portion of the second delivery catheter passes through a side hole in the first stent. The first stent is crimped over the first and second catheters such that the first stent remains attached to the first and the second catheters during advancement of the catheters through a blood vessel.

Abstract: The present disclosure describes systems for endoluminal devices utilizing a sleeve for constraining an expandable device toward a constrained configuration suitable for endoluminal delivery to a treatment site along vasculature; and a mechanism for retracting at least a portion of the sleeve.

Abstract: A delivery device according to principles described herein includes a catheter having three concentric shafts including an inner core, an outer sheath over the inner core and an outer support shaft at least partially extending over the inner core and the outer sheath. A timing belt having a plurality of belt teeth on a surface of the timing belt is coupled to an outer sheath over a medical device or stent on the inner core such that movement of the timing belt link causes movement of the outer sheath from its position over the medical device or stent. The delivery device is actuated by rotation of a thumbwheel a thumbwheel coupled to a barrel having a plurality of teeth such that rotation of the thumbwheel causes movement of the barrel such that the barrel teeth engage the belt teeth to cause movement of the timing belt causing movement of the outer sheath.

Abstract: Disclosed herein are systems and methods for aiding a surgeon to perform a surgical procedure on an eye. The surgical procedure includes inserting an elongate probe from an opening into the eye across an anterior chamber to a target tissue region comprising a trabecular meshwork and a Schlemm's canal. Exemplary systems include an optical microscope for the surgeon to view the eye with a microscope image during the procedure; an optical coherence tomography (OCT) apparatus configured to perform an OCT scan of a target location in the target tissue region during the procedure; and an image processing apparatus configured to generate an augmented image by overlaying an OCT image of target location and a graphical visual element identifying the locations, wherein the graphical visual element is registered with the microscope image to aid the surgeon in advancing a distal end of the elongate probe to the target location.

Abstract: The disclosure relates to a method for triggered acquisition of a measured data set by a magnetic resonance system, to a corresponding computer program, to a corresponding data memory and to the corresponding magnetic resonance system. In the method, a cyclical signal is detected, which describes a cyclical change in a target object to be imaged. Cycles are automatically identified in this cyclical signal. Furthermore, at least one property of the cyclical signal is automatically determined. It is then automatically determined whether triggering of a single measurement for acquisition of some of the measured data set is permitted in an identified cycle of the cyclical signal. This determination is made as a function of the at least one determined property of the cyclical signal and a specified reference value of an acquisition parameter.

Abstract: A delivery device according to principles described herein includes a catheter having three concentric shafts including an inner core, an outer sheath over the inner core and an outer support shaft at least partially extending over the inner core and the outer sheath. A timing belt having a plurality of belt teeth on a surface of the timing belt is coupled to an outer sheath over a medical device or stent on the inner core such that movement of the timing belt link causes movement of the outer sheath from its position over the medical device or stent. The delivery device is actuated by rotation of a thumbwheel a thumbwheel coupled to a barrel having a plurality of teeth such that rotation of the thumbwheel causes movement of the barrel such that the barrel teeth engage the belt teeth to cause movement of the timing belt causing movement of the outer sheath.

Abstract: A vascular intervention device delivery system includes a thumbwheel rotatably mounted in a handle. A termination assembly is mechanically connected to the handle. A catheter extends through the termination assembly and has a proximal end attached to the handle, and a distal carrier segment for mounting a vascular intervention device. A retractable sheath is movable from a first position covering the distal carrier segment to a second position retracted proximally to uncover the distal carrier segment. A pull extends between the thumbwheel and the retractable sheath, and through the termination assembly. A stability sheath that receives the pull and the inner catheter has a proximal end that terminates in the termination assembly.

Abstract: An example introducer is disclosed. An example introducer includes an inner liner including a lumen, a proximal region, and at least one folded portion extending longitudinally along the proximal region. The introducer further includes an expandable support member. The support member includes a plurality of ribs extending along a length of the support member. The introducer further includes a sheath attached to at least a portion of the support member and the support member is designed to shift from a first position to an expanded position.

Abstract: Patient-specific 3D complex coils and methods of making and using such coils, including custom fixtures for the manufacture of such coils. Such patient-specific 3D complex coils improve treatment outcomes for cerebral aneurysm repair. The aneurysm may be an aneurysm in a specific patient and/or population of patients having a similar aneurysm shape and size.

Abstract: In one embodiment, a delivery apparatus handle, such as for a mechanical heart valve frame can comprise an actuation knob with a toggle mechanism that can toggle the actuation knob from a first state in which the actuation knob is operable to cause the linear or rotational movement of multiple elements or sets of elements, such as tubes that are attached to, e.g., a mechanical heart valve frame to cause expansion or collapsing of the frame, to a second state in which only a single element or set of elements is moved, allowing for additional operations, such as, e.g., locking the frame and/or releasing it from the delivery apparatus.

Abstract: A cylindrical indwelling medical device is formed by connecting a plurality of struts in a circumferential direction of the device in such a way to share a rib in an axial direction in neighboring struts to form annular or spiral columns of struts and connecting the columns of struts in the axial direction via links. Each strut has at least one set of strut pieces providing a bistable structure for supporting a load from reducing a diameter of the indwelling medical device and portions for inducing snap-through buckling deformation. load is in a direction preventing reverse snap-through buckling deformation to hold an expanded diameter state of the device. After the indwelling medical device with its diameter reduced has been introduced into a luminal organ and has expanded its diameter to indwell there, the device can resist sufficiently against the reduction in diameter, thus maintaining the expanded diameter state of the device.

Abstract: Catheter-based delivery systems for delivery and retrieval of a leadless pacemaker include features to facilitate improved manipulation of the catheter and improved capture and docking functionality of leadless pacemakers. Such functionality includes mechanisms directed to deflecting and locking a deflectable catheter, maintaining tension on a retrieval feature, protection from anti-rotation, and improved docking cap and drive gear assemblies.

Abstract: An embolic protection and filtration device (EFD) that is deployable within the aortic arch of a patient to prevent emboli from entering the coronary arteries. The device includes a collapsible tubular chassis having enlarged opposing end portions and a midsection of smaller radial dimension. A filtration membrane is disposed at least on upstream and midsection portions of the chassis and is configured to filter and shunt large emboli down the descending aorta and away from the coronary arteries. A retrieval device is provided for retrieving the EFD from within the patient. The retrieval device automatically compensates for elongation of the EFD as the EFD is radially contracted such that the EFD is not moved or drug along the aorta as it is collapsed and retracted into a retrieval catheter.

Abstract: The device, that can be implanted in the intestinal cavity, comprises a reactor comprising a semi-permeable or porous membrane or coating linked to a element for attachment to an intestinal or gastric wall. The reactor can be in the form of a ribbon, a structure having more than two faces or an open structure delimiting a lumen, comprising, or formed from, a semi-permeable or porous membrane. The reactor can also delimit, at least partially with the semi-permeable or porous membrane of same, a closed inner space. The reactor can comprise or carry enzymes or micro-organisms, in particular bacteria or yeast. The reactor is used for generating a chemical reaction with one or more molecules present in the intestine, or for producing one or more biologically active molecules. It can, in particular, be used for consuming sugars, disaccharides and simple sugars or producing essential amino acids or other molecules having a positive effect on the health.

Abstract: Methods and devices useful, for example, in the field of angioplasty and stenting are disclosed. In some embodiments, the methods, devices and kits are configured for directional expansion inside a lumen, for example of a blood vessel obstructed by plaque. In some embodiments, the directional expansion displaces the plaque in a desired direction.

Abstract: Devices, systems and methods are described herein a prosthesis for implantation within a lumen or body cavity and delivery devices for delivering the prosthesis to a location for implantation. A delivery system can include a plurality of components which are moveable relative to each other. The delivery system can include a nose cone which can cover at least a first end of the prosthesis, an outer elongate member which can cover at least a second end of the prosthesis, and a tether which can at least partially restrain the prosthesis from deployment.

Abstract: Embodiments of the present disclosure provide methods of loading a prosthetic heart valve within a delivery apparatus such that it can be used for delivery of the prosthetic heart valve to a native valve site via the human vasculature. The methods can include attaching the prosthetic heart valve to a valve-retaining mechanism at a distal end of the catheter and causing a torque shaft of the delivery apparatus to rotate relative to the catheter, wherein the torque shaft extends within the catheter and is coupled to the valve delivery sheath. Rotation of the torque shaft relative to the catheter can cause relative longitudinal movement between the valve sheath and the prosthetic heart valve such that the prosthetic heart valve is covered by the valve sheath.

Abstract: Guide extension catheters and related methods are disclosed. A guide extension catheter can comprise an elongate tube member, a push member, and a removable support member. The push member can be eccentrically coupled directly or indirectly to the elongate tube member and can extend proximally therefrom for slidably positioning the elongate tube member within and partially beyond a distal end of a guide catheter. The removable support member can comprise a structure that surrounds at least a portion of the push member. The removable support member alone, or when placed over the push member, can be more rigid along its longitudinal axis than the elongate tube member and can have a cross-sectional dimension that is greater than a maximal cross-sectional dimension of the push member.

Abstract: The present invention relates to a delivery apparatus for delivering a radially self-expanding medical device (2) having a proximal portion and a distal portion, said delivery apparatus comprising an elongated tubular member having a proximal end, a distal end and a lumen (122) extending along a longitudinal axis from the proximal end to the distal end; a sheath (11), said sheath (11) being coaxially disposed around the elongated tubular member (12); wherein the elongated tubular member (12) is movable relative to the sheath (11); and wherein the sheath (11) is configured for receiving the radially self-expanding medical device (2) in a radially compressed state; and a holding and retrieving mechanism configured to constrain radially the proximal portion of the radially self-expanding medical device (2) such that in response to a proximal movement of the elongated tubular member (12) relative to the sheath (11), the holding and retrieving mechanism (13) constrains radially the proximal portion of the radially

Abstract: Described is an apparatus for transcatheter detachment of a stent from a delivery device. A single-ended draw line with loops is inserted through a restraining hole in a glide and a release line is inserted through the loops. The single-ended draw line is thus prevented from pulling through the restraining hole while the release line is through the loops. The single-ended draw line is free to pass through the restraining hole after the release line is pulled out of the loops and thereafter pulled free of stent holes formed through a stent, thereby detaching the stent at a desired location.

Abstract: This patent document discloses guide extension catheters for use with a predefined length guide catheter and related methods for treating blood vessel lesions and abnormalities. A guide extension catheter can include a push member, an elongate tube member, and a balloon radially surrounding a portion of the elongate tube member. The balloon can include an inflatable tube coupled to an elongate shaft having a lumen for receiving inflation fluid, and the inflatable tube can be coiled in a helical manner around the elongate tube member. A bioactive layer can coat an outer surface portion of the balloon and, when the balloon is inflated, one or more drugs of the bioactive layer can be received by the blood vessel. Inflation of the balloon can engage the elongate tube member with an inner surface of the blood vessel and/or an inner surface of the guide catheter.

Abstract: A stent delivery system includes a shaft extending from a proximal end of the system into a delivery tip at a distal end. The shaft includes a coil and a stent bed. A stent is loaded onto the stent bed and has a first portion at its distal end having a greater flexibility than a second portion at its proximal end. Sheathing is moveable over the stent bed between pre-deployed and deployed positions. The sheathing includes a flexible section at the sheathing distal end, a semi-flexible section adjacent the flexible section, and a stiff section adjacent the semi-flexible section. The delivery tip is more flexible than the combination of the stent bed, the first portion of the stent, and the flexible section of the sheathing, which is more flexible than the combination of the stent bed, the second portion the stent, and the flexible section of the sheathing.

Abstract: A mitral cerclage annuloplasty apparatus comprises a tissue protective device and a knot delivery device. The tissue protective device comprises a first protective tube and a second protective tube. The knot delivery device comprises a tube wherein a loose knot is looped around its distal end through a hole and wherein tight knot is formed when the distal end of the tube is cut open. Alternatively, the knot delivery device comprises an inner tube and outer tube. The inner tube is insertable and rotatable inside the outer tube. When the tubes are in a closed position by rotating either the outer tube or the inner tube, a hole is created near its distal end. When the tubes are in open position by rotating either the outer tube or the inner tube, the hole joins the opening of the outer tube and lengthens.

Abstract: A prosthesis delivery device having a cannula with an expandable positioning device disposed at the proximal end thereof is disclosed. A prosthesis is retained on the cannula distal of the expandable device. Expansion of the expandable device retains and centers the delivery device and the prosthesis carried thereon in the vessel and allows repositioning of the prosthesis without contacting the proximal end of the prosthesis with the vessel walls prior to deployment.

Abstract: An exemplary valve repair system for repairing a native valve of a patient during a non-open-heart procedure includes a delivery device and a valve repair device. The delivery device includes a catheter, an actuation shaft, and a coupler. The valve repair device is configured to be delivered through the catheter. The valve repair device is configured to attach to a native valve of a patient. The valve repair device includes a coaption element having a first end portion and a second end portion, a proximal collar attached to the first end portion of the coaption element, first and second paddles connected to the coaption element, and a distal collar connected to the first and second paddles. The coupler is releasably connected to the proximal collar. The actuation shaft extends through the coupler, the proximal collar, and the coaption element. The actuation shaft is releasably connected to the distal collar.

Abstract: Delivery devices for delivering a stented prosthesis to a target site are disclosed. Certain disclosed delivery devices include a handle assembly including an actuator, a 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 torque shaft that is configured to apply and adjust the amount of tension in the each tension member. For example, the torque shaft can be configured to wind and unwind each elongate tension member around the torque shaft to correspondingly compress and expand the stented prosthesis. The torque shaft can be controlled with an actuator provided in the handle assembly, for example. In some embodiments, the actuator is further configured to axially move the torque shaft.

Abstract: A vascular intervention device delivery system, such as for implanting a stent, includes a thumbwheel rotatably mounted in a handle. A catheter has a proximal end attached to the handle, and a distal carrier segment for mounting a vascular intervention device thereon. A retractable sheath is movable from a first position covering the distal carrier segment to a second position retracted proximally uncovering the distal carrier segment. A pull extends between the thumbwheel and the retractable sheath. A latch is positioned in the handle and moveable from a locked position at which the latch engages the radially outward thumb surface, and an unlocked position at which the latch is out of contact with the thumbwheel. A pusher, which is partially positioned outside of the handle, is operable to move the latch from the locked position to the unlocked position. The retractable sheath moves responsive to rotation of the thumbwheel.

Abstract: A system for treating a bifurcation includes first and second delivery catheters, each having an expandable member and a stent. The stent on the second delivery catheter has a side hole. A portion of the first delivery catheter is disposed under a portion of the stent on second delivery catheter. The first delivery catheter is slidable relative to the second delivery catheter, and the first delivery catheter passes through the side hole.

Abstract: An exemplary recapturable valve repair system for repairing a native valve of a patient during a non-open heart procedure has a delivery device, a valve repair device, and a tethering line. The delivery device has a catheter and a coupler. The valve repair device is configured to be delivered through the catheter and attach to a native valve of a patient. The valve repair device includes a coaption element, a proximal collar, and first and second paddles. The first and second paddles are connected to the coaption element. The coupler is releasably connected to the proximal collar. The tethering line connects the valve repair device to the delivery device for recapturing the valve repair device.

Abstract: A vascular occluding device for modifying blood flow in a vessel, while maintaining blood flow to the surrounding tissue. The occluding device includes a flexible, easily compressible and bendable occluding device that is particularly suited for treating aneurysms in the brain. The neurovascular occluding device can be deployed using a micro-catheter. The occluding device can be formed by braiding wires in a helical fashion and can have varying lattice densities along the length of the occluding device. The occluding device could also have different lattice densities for surfaces on the same radial plane.

Abstract: An endovascular prosthesis includes a stent-graft and an external coagulation inducer. The stent-graft includes a first portion of structural strut members and a first portion of a graft member, which, when the endovascular prosthesis is unconstrained in a radially-expanded state, together are shaped so as to define a blood-carrying tubular structure defining a lumen. The external coagulation inducer includes an extra-luminal skirt, which includes a second portion of the structural strut members and a second portion of the graft member, and is configured to assume: (i) when the endovascular prosthesis is removably disposed in a delivery sheath, a radially-compressed delivery state, in which the structural strut members of the first portion do not coincide with the structural stent members of the second portion, and (ii) when the endovascular prosthesis is unconstrained, a radially-expanded state, in which the extra-luminal skirt extends radially outward from an external surface of the stent-graft.

Abstract: A releasable elongated assembly includes a release member having a length and an opening that extends along the length. The releasable elongated assembly includes a first elongated element having a first coupling member disposed in the opening and a second elongated element having a second coupling member disposed in the opening opposite the first coupling member along the length. The first and second elongated elements are interlaced with each other in the opening at a location between the first coupling member and the second coupling member such that the first and second elongated elements are attached to each other. The release member is moveable from a first position where the first and second coupling members are captured in the opening to a second position where the first and second coupling members are released from the opening so as to detach the first and second elongated elements from each other.

Abstract: Controlled deployable medical devices that are retained inside a body passage and in one particular application to vascular devices used in repairing arterial dilations, e.g., aneurysms. Such devices can be adjusted during deployment, thereby allowing at least one of a longitudinal or radial re-positioning, resulting in precise alignment of the device to an implant target site.

Abstract: A deployment device for deploying an expandable endoluminal prosthesis within a body vessel may include an elongate member extending longitudinally along at least a portion of a length of the deployment device. The deployment device may include at least one engagement member coupled to the elongate member and extending outwardly from the elongate member. The deployment device may include a circumferential trigger wire extending at least partially circumferentially around the elongate member and removably received between the engagement member and the elongate member. The circumferential trigger wire may be manipulatable from a distal end of the deployment device, whereby the circumferential trigger wire is removable from between the engagement member and the elongate member.

Abstract: A delivery device can provide sequential delivery of a plurality of intraluminal devices or tacks held in a compressed state on the delivery device. Delivery platforms on the delivery device can hold a tack in a compressed position and have a unique shape, such as a non-constant outer diameter, an hourglass shape, a tapered proximal half, ridges, dimples, etc. This unique shape can be positioned between annular pusher bands that may also be radiopaque markers. In some embodiments, the unique shape is provided by a sleeve of flexible material with the unique shape surrounding a harder inner shaft. Further, the annular pusher bands can be made of wire or sections of material to increase flexibility while remaining radiopacity. A tack deployment method can include alignment of radiopaque markers on the outer sheath and the tack to be deployed prior to deployment.

Abstract: A system for crimping a fully deployed heart valve includes a delivery tube extending in a longitudinal direction and having a lumen for receiving the crimped heart valve, a deployment device including a first member and a second member moveably secured to the first member, and a sheath configured to at least partially enclose a radially collapsible stent. A first attachment area of the sheath is connected to the first member and a second attachment area of the sheath is connected to the second member such that movement of the first member relative to the second member tensions the sheath for crimping the heart valve. A method of crimping a fully deployed heart valve is also provided.

Abstract: A stent-valve for transcatheter implantation to replace a cardiac valve, the stent valve being compressible to a compressed state for delivery, and expandable to an operative state for implantation, the stent-valve comprising a stent, a plurality of leaflets for defining a prosthetic valve, an inner skirt, an outer skirt, and a paravalve seal for sealing against surrounding tissue. In some embodiments, the paravalve seal comprises material that swells in response to contact with blood. In some embodiments, the seal comprises a flap or pocket that is distensible in response to backpressure and/or paravalve back-flow of blood.

Abstract: A method for implanting a stent by providing an implantation system including a catheter, an expandable element, and a delivery wire, moving a first portion of the expandable element to exit the catheter, and maintaining a second portion of the expandable element within the catheter to establish a partially implanted configuration. Then moving the delivery wire independent of the expandable element in the partially implanted configuration, and enlarging a circumference of the expandable element in response to the moving the delivery wire.

Abstract: Numerous delivery devices for delivery of a stented prosthesis, such as a stented prosthetic heart valve. Various delivery devices include a capsule that is advanced proximally to retain the stented prosthesis, which is secured over an inner shaft assembly of the delivery device. The delivery device further includes a bumper or bumper assembly to provide a smooth transition of the capsule over the stented prosthesis. In some alternate disclosed embodiments, the bumper further serves to connect various elements of the inner shaft assembly. Additional embodiments include a bumper assembly arranged and configured to longitudinally expand and contract to substantially fill any open space as the capsule is retracted from the stented prosthesis, which prevents kinking in the capsule. Additional embodiments include proximal and/or distal bumpers for temporarily covering and smoothing the ends of the stented prosthesis as part of a delivery device that does not include a capsule.

Abstract: A delivery system for delivering an implant having both a rigid portion and a flexible portion to a body lumen. The delivery system includes an outer tubular member and an inner tubular member slidably disposed within the lumen of the outer tubular member. The inner tubular member includes at least one opening positioned in a side wall adjacent to a distal end region. An expandable implant, including a rigid portion and a flexible portion, is disposed about the outer surface of the inner tubular member. A distal portion of a thread is wrapped around the flexible portion of the implant and configured to maintain the flexible portion in a radially collapsed configuration during delivery of the implant. A distal end region of the outer tubular member is disposed around the rigid portion of the implant to maintain the rigid portion in a radially collapsed configuration during delivery of the implant.

Abstract: The invention is suitable for use in medicine for maximally precise, safe and quick positioning a coronary stent in case of simple and complicated anatomical lesions of the coronary bed as well as for stenting renal, visceral arteries. The claimed device comprise a body with a tail portion, a screw rotation wheel, a screw, a slider with a cam, a bush with clip and a rubber coupling provided thereon, a wedge comprised of two members, a spring and a lock button arranged in the body. In preparation to use the device, the coronary stent on the delivery system is first successively introduced into the device whereafter the coronary stent on the delivery system is manually advanced to the affected area of the coronary artery, the delivery system is locked in the device and the stent is positioned within the coronary artery by means of the rotation wheel.

Abstract: In some embodiments, a valve prosthesis includes an inlet portion that is substantially s-shaped and configured to engage the floor of the outflow tract of the native heart atrium. In some embodiments, a valve prosthesis includes a chordae guiding element configured to reduce bending of the chordae to reduce stress on the chordae during the cardiac cycle. In some embodiments, a valve prosthesis includes a central portion having an hourglass shape configured to pinch a native annulus in order to provide axial fixation of the valve prosthesis within a valve site. In some embodiments, a valve prosthesis includes a frame having an outflow end that is flared to provide a gap between an outflow end of the frame and an outflow end of prosthetic leaflets when the prosthetic leaflets are fully opened.

Abstract: The invention relates to a problem of setting mutual position of an anatomy being imaged and imaging means of a computed tomography imaging apparatus so that specifically the very volume of the anatomy desired to be imaged actually is imaged. To further the positioning, a positioning tool in a form of a three-dimensional virtual positioning model (40), generated from the anatomy to be imaged, is shown on a display from which the volume (41) of the anatomy desired to be imaged can be pointed, selected or defined.

Abstract: This disclosure describes, inter alia, materials, devices, kits and methods that may be used for loading scaffolds into delivery devices and delivery of scaffolds into the body of a patient, including delivery of scaffolds to the sinuses for the treatment of chronic sinusitis, among other purposes.

Abstract: A stent delivery system includes an elongate shaft including a proximal portion, a distal portion, at least one lumen extending at least partially therethrough, and a stent receiving portion on the distal portion of the elongate shaft. A stent is positioned on the stent receiving portion of the elongate shaft, the stent having a first configuration and a second configuration. A sheath is positioned longitudinally around the inner elongate shaft, the inner elongate shaft extending coaxially at least partially within the lumen of the outer sheath, the outer sheath moveably positionable relative to the outer elongate shaft. A proximal constraining arrangement is engaged with a proximal end of the stent. A distal constraining arrangement is engaged with a distal end of the stent. A handle assembly is connected to the proximal constraining arrangement, the distal constraining arrangement, and the outer sheath. A brake assembly is positioned within the handle assembly.

Abstract: A delivery device for a prosthetic mitral valve includes five sheaths and a handle. The first sheath is coupled to a first handle portion and is rotatable and bendable. The second sheath is coupled to a second handle portion and extends through the first sheath. The second sheath is bendable, rotatable and translatable relative to the first sheath. The third sheath is coupled to a third handle portion and extends through the first and second sheaths. The third sheath is translatable relative to the second sheath. The second handle portion is coupled to the first and third handle portions. The fourth sheath extends through the third sheath and forms part of a compartment to store the prosthetic valve. The fifth sheath extends through the fourth sheath to a tip and is coupled to a retaining sheath that closes the compartment to retain the valve in a collapsed condition.

Abstract: Systems, devices, and methods for reducing regurgitation through an atrioventricular heart valve: i.e., the mitral valve and the tricuspid valve. The device includes a flexible anchor rail anchored in the tissue of the ventricle and an offset coaptation element on a catheter that rides over the anchor rail and is positionable between the valve leaflets. The proximal end of the coaptation catheter is fixed subcutaneously adjacent the subclavian vein. The coaptation element includes an inert covering over a foam interior, and is radially offset on the catheter so that the foam body projects away from the septal side of the valve to reduce or minimize deformation from contact with the septal wall of the ventricle. Markers on the coaptation element facilitate positioning in the desired rotational orientation during delivery and implant.

Abstract: An apparatus and method for a micro-patterned thin film Nitinol (TFN) that is used as a cover for an expandable stent structure, and has elongation/expansion properties that are configured to match the elongation/expansion properties of the expandable stent structure is presented.