Abstract: Stented prosthetic heart valves comprising a stent frame having a compressed arrangement for delivery within a patient's vasculature and an expanded arrangement for deployment within a native heart valve. The stented prosthetic heart valves including a paravalvular leakage prevention or mitigation wrap that encircles a stent frame and is formed of a flexible material having a variable diameter defined by a greatest distance between the wrap and the stent frame. The wrap further includes a first end coupled to the stent frame and an opposing second end that is not coupled to the stent frame, wherein the wrap can selectively enlarge its diameter in situ via movement of the second end. Devices for and methods of selectively deploying the wrap are also disclosed.

Abstract: A valve delivery system and valve delivery method are disclosed. The valve delivery system includes an inner shaft extending along a longitudinal axis and an elongated tension member to continuously circumferentially coil around a prosthetic valve disposed on the inner shaft to form a sheath portion to releasably contain the prosthetic valve on the inner shaft in a compressed state, the elongated tension member extending from the sheath portion along the longitudinal axis of the inner shaft.

Abstract: The present technology is a prosthetic heart valve device, and related systems and methods, for treating a native valve of a human heart having a native annulus and native leaflets. One embodiment comprises a valve support, a prosthetic valve assembly within the valve support, and an anchoring member having an upstream portion and a downstream portion. The device further includes an extension member coupled to the fixation frame and extending radially outward therefrom. The extension member includes a plurality of wires, at least a portion of which include an inner core surrounded by an outer material. The wires include a plurality of recesses extending through at least a portion of the thickness of the outer material, and a therapeutic agent in the recesses for delivery to the anatomy when the prosthetic heart valve device is positioned at a native annulus.

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: A transcatheter prosthesis with radially compressed and expanded configurations. An elongate member encircling at least a portion of the prosthesis, and configured to provide a seal between the prosthesis and a native anatomy when the prosthesis is deployed in the radially expanded configuration. The elongate member may be a resilient elongate member having a radially contracted state, when in tension, to hold at least the portion of the prosthesis in the radially compressed configuration, and having a radially expanded state, when relaxed, to provide the seal between at least the portion of the prosthesis and a native anatomy when the prosthesis is deployed. A system for delivering the transcatheter prosthesis may include a delivery catheter having an elongate cinching member encircling at least a second portion of the prosthesis, wherein the elongate cinching member is configured to hold the second portion of the prosthesis in the radially compressed configuration.

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: The present technology is a prosthetic heart valve device, and related systems and methods, for treating a native valve of a human heart having a native annulus and native leaflets. One embodiment comprises a valve support, a prosthetic valve assembly within the valve support, and an anchoring member having an upstream portion and a downstream portion. The device further includes an extension member coupled to the fixation frame and extending radially outward therefrom. The extension member includes a plurality of wires, at least a portion of which include an inner core surrounded by an outer material. The wires include a plurality of recesses extending through at least a portion of the thickness of the outer material, and a therapeutic agent in the recesses for delivery to the anatomy when the prosthetic heart valve device is positioned at a native annulus.

Abstract: A transcatheter prosthesis with radially compressed and expanded configurations. An elongate member encircling at least a portion of the prosthesis, and configured to provide a seal between the prosthesis and a native anatomy when the prosthesis is deployed in the radially expanded configuration. The elongate member may be a resilient elongate member having a radially contracted state, when in tension, to hold at least the portion of the prosthesis in the radially compressed configuration, and having a radially expanded state, when relaxed, to provide the seal between at least the portion of the prosthesis and a native anatomy when the prosthesis is deployed. A system for delivering the transcatheter prosthesis may include a delivery catheter having an elongate cinching member encircling at least a second portion of the prosthesis, wherein the elongate cinching member is configured to hold the second portion of the prosthesis in the radially compressed configuration.

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 transcatheter prosthesis with radially compressed and expanded configurations. An elongate member encircling at least a portion of the prosthesis, and configured to provide a seal between the prosthesis and a native anatomy when the prosthesis is deployed in the radially expanded configuration. The elongate member may be a resilient elongate member having a radially contracted state, when in tension, to hold at least the portion of the prosthesis in the radially compressed configuration, and having a radially expanded state, when relaxed, to provide the seal between at least the portion of the prosthesis and a native anatomy when the prosthesis is deployed. A system for delivering the transcatheter prosthesis may include a delivery catheter having an elongate cinching member encircling at least a second portion of the prosthesis, wherein the elongate cinching member is configured to hold the second portion of the prosthesis in the radially compressed configuration.

Abstract: Aspects of the disclosure include methods, systems and devices for severing and optionally removing at least a portion of heart valve leaflets. Leaflets can be partially removed or entirely removed or otherwise, the leaflets can be severed or splayed in such a way as to avoid coronary blockage, LVOT obstruction, or access challenges in procedures where a prosthetic valve is to be implanted within a previously implanted prosthetic valve. Aspects of the disclosure also relate to numerous devices for and methods of disabling one or more valve ligating devices to provide an unobstructed valve opening so that a prosthetic heart valve can be implanted within the opening. The ligation device(s) is disabled either by removing the ligation device(s) or severing one leaflet so that ligated leaflets can be separated. In some embodiments, the ligation device(s) are severed to disable the ligation device(s).

Abstract: Aspects of the disclosure include methods, systems and devices for severing and optionally removing at least a portion of heart valve leaflets. Leaflets can be partially removed or entirely removed or otherwise, the leaflets can be severed or splayed in such a way as to avoid coronary blockage, LVOT obstruction, or access challenges in procedures where a prosthetic valve is to be implanted within a previously implanted prosthetic valve. Aspects of the disclosure also relate to numerous devices for and methods of disabling one or more valve ligating devices to provide an unobstructed valve opening so that a prosthetic heart valve can be implanted within the opening. The ligation device(s) is disabled either by removing the ligation device(s) or severing one leaflet so that ligated leaflets can be separated. In some embodiments, the ligation device(s) are severed to disable the ligation device(s).

Abstract: Aspects of the disclosure relate to packaging assemblies including a tray having at least one compartment adapted to receive a medical device component or product. The packaging assemblies a barrier film covering the compartment and a lid pivotally attached to the tray; wherein the tray and the lid each include cooperative latching features. The lid defines a recess in which one or more product items can be stored and the packaging assembly further includes a label removably secured over the recess and the sheet of product documentation. Methods of assembling, sterilizing and opening such packaging assemblies are also disclosed.

Abstract: A device and method for ablating tissue is disclosed comprising the steps of acquiring an anatomical image of a patient, correlating the image to the patient, guiding an ablating member within the patient while tracking the position of the ablating member in the patient, positioning the ablating member in a desired position to ablate tissue, emitting ablating energy from the ablating member to form an ablated tissue area and removing the ablating member from the patient.

Abstract: A delivery system for transcatheter implantation of a heart valve prosthesis. The delivery system includes an outer sheath component defining a lumen therethrough, an elongate tube having at least two flat wires longitudinally extending from a distal end thereof, and self-expanding first and second frames disposed in series within a distal portion of the outer sheath component and held in a compressed delivery configuration therein. The elongate tube and the at least two flat wires are slidably disposed within the lumen of the outer sheath component. In the compressed delivery configuration the at least two flat wires longitudinally extend along exterior portions of the first and second frames and are woven through adjacent ends of the first and second frames to releasably couple them to each other. Proximal retraction of the at least two flat wires from the first and second frames releases at least the first frame from the delivery system.

Abstract: A delivery system for transcatheter implantation of a heart valve prosthesis. The delivery system includes an outer sheath component defining a lumen therethrough, an elongate tube having at least two flat wires longitudinally extending from a distal end thereof, and self-expanding first and second frames disposed in series within a distal portion of the outer sheath component and held in a compressed delivery configuration therein. The elongate tube and the at least two flat wires are slidably disposed within the lumen of the outer sheath component. In the compressed delivery configuration the at least two flat wires longitudinally extend along exterior portions of the first and second frames and are woven through adjacent ends of the first and second frames to releasably couple them to each other. Proximal retraction of the at least two flat wires from the first and second frames releases at least the first frame from the delivery system.

Abstract: A tool for compressing a stented prosthesis. The tool includes first and second sets of rollers. The first set includes a plurality of rollers arranged to define a first working region having a first working diameter. The second set includes a plurality of rollers arranged to define a second working region having a second working diameter. The sets of rollers are arranged such that the working regions are axially aligned. The first working diameter is greater than the second working diameter. A stented prosthesis traversing the first working region and then the second working region is forced to a compressed state. In some embodiments, the tool includes one or more intermediate sets of rollers between the first and second sets of rollers, with each of the intermediate sets of rollers defining a working region having a working diameter. The respective working diameters progressively decrease in a downstream direction.

Abstract: Methods of transcatheter delivery of a prosthetic heart valve. A distal region of a guide member assembly is advanced into a heart of a patient. The distal region is docked to native anatomy of the heart. A delivery device, including a collapsed prosthetic heart valve, is advanced over the docked guide member assembly. The collapsed prosthetic heart valve is located at an implantation site. The prosthetic heart valve is deployed from the delivery device, and then the delivery device is removed from the patient. At least a portion of the guide member assembly is removed from the patient. In some embodiments, the docking structure is docked to one or more of native mitral valve leaflets, chordae in the left ventricle, or walls of the left ventricle as part of a transseptal mitral valve delivery procedure.

Abstract: A method for treating a human patient includes emitting ultrasound energy from an ultrasound transducer positioned remotely from target tissue of the patient. The ultrasound transducer is positioned at a desired location relative to the patient and target tissue using location and imaging techniques. The method further includes focusing the ultrasound energy such that one or more focal points are directed to the target tissue of the patient and ablating the target tissue at each focal point. The target tissue is ablated via the focused ultrasound energy without ablating non-target tissue through which the ultrasound energy passes between the ultrasound transducer and the one or more focal points.

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.