Abstract: A system for treating aortic dissection including an aortic dissection implant comprising an expandable anchoring structure and an elongate tubular structure. The expandable anchoring structure can be configured to apply radial force to the sinuses of the aortic root and/or the sinotubular junction when expanded. The elongate tubular structure can comprise an expandable support frame and one or more layers. The expandable support frame can be configured to extend from the descending aorta to the ascending aorta and curve along with a curvature of the aortic arch when expanded within the aorta. The one or more layers can comprise a first porous layer comprising an atraumatic outer surface positioned over the expandable support frame and a second non-porous layer positioned over a portion of the first porous layer. The second non-porous layer may be configured to be positioned on opposite sides of the aortic dissection and to be inflatable via blood flow to seal against the dissection.

Abstract: A replacement heart valve includes a self-expanding frame having an upstream end and a downstream end. A plurality of anchors extends from the downstream end of the frame. A valve skirt is attached to the frame and a valve body is attached to the valve skirt, wherein the valve body includes leaflets for providing one-way flow through the replacement valve. The frame preferably includes a plurality of connector eyelets sized to receive at least one tether. The replacement heart valve is radially collapsible for delivery within a delivery device and radially expandable for engaging a native heart valve annulus upon release from the delivery device. The tether may be used to control expansion and/or adjust the diameter of the replacement heart valve during deployment.

Abstract: A transfemoral delivery system for implanting a replacement heart valve is provided. The replacement heart valve includes an expandable frame and a plurality of distal anchors. The delivery device includes an outer sheath assembly, a mid-shaft assembly, and an inner assembly, wherein the outer sheath assembly and the mid shaft assembly retain the replacement heart valve in a radially compacted state. The outer sheath assembly is retracted relative to the mid-shaft assembly to release the distal anchors while a portion of the replacement heart valve remains retained by the mid shaft assembly. After the distal anchors engage leaflets of the native heart valve, the retained portion of the replacement heart valve is released from the mid-shaft assembly and is allowed to fully expand.

Abstract: A prosthetic cardiac valve comprises an anchor having an atrial skirt, an annular region, and a ventricular skirt. The prosthetic valve also has a plurality of prosthetic valve leaflets each having a first end and a free end. The first end is coupled with the anchor and the free end is opposite the first end. The prosthetic cardiac valve has an open configuration in which the free ends of the prosthetic valve leaflets are disposed away from one another to allow antegrade blood flow therepast, and a closed configuration in which the free ends of the prosthetic valve leaflets engage one another and substantially prevent retrograde blood flow therepast. The anchor has a collapsed configuration for delivery to the heart and an expanded configuration for anchoring the prosthetic cardiac valve to a patient's heart.

Abstract: Disclosed herein are delivery systems and methods for delivering a prosthetic heart valve to a native heart valve of a heart. An exemplary delivery system may include a shaft portion having at least one shaft, at least one steering wire, and at least one pull wire. The system may further include a handle portion coupled to a proximal end of the shaft portion and a capsule portion coupled to a distal end of the shaft portion. The capsule portion may be configured to house the prosthetic heart valve. At least one portion of the delivery system may be configured to be engaged with the prosthetic heart valve when the prosthetic heart valve is implanted in the native heart valve of the heart.

Abstract: Described herein are prosthetic heart valves and methods for improving the functionality of native heart valves. An exemplary prosthetic heart valve may include one or more support structures, in which at least one support structure defines an elongate central passageway having a longitudinal. The prosthetic heart valve may include a plurality of leaflet elements attached to the at least one support structure and disposed within the elongate central passageway for control of blood flow through the elongate central passageway. The at least one support structure may be configured to biodynamically fix the prosthetic heart valve to native leaflets of a native heart valve of a heart.

Abstract: Various systems, devices, components and methods are disclosed for controllably and selectively occluding, restricting, and/or diverting flow within a patient's vasculature. The flow restriction systems can include an implant having a flow restrictor and an implantable controller having an actuator for actuating the flow restrictor. The flow restriction systems can also include an external device for controlling operation of the implant via the implantable controller.

Abstract: A system for percutaneous ventriculoplasty. Anchors can be placed in the ventricular septum and the ventricular wall. Sutures tethered to the anchors can be tensioned to reduce the size of a dilated left ventricle. Multiple anchors can be positioned in the ventricular wall and the sutures can be independently tensioned to allow tailored treatment of the dilated ventricle.

Abstract: A transfemoral delivery system for implanting a replacement heart valve is provided. The replacement heart valve includes an expandable frame and a plurality of distal anchors. The delivery device includes an outer sheath assembly, a mid-shaft assembly, and an inner assembly, wherein the outer sheath assembly and the mid shaft assembly retain the replacement heart valve in a radially compacted state. The outer sheath assembly is retracted relative to the mid-shaft assembly to release the distal anchors while a portion of the replacement heart valve remains retained by the mid shaft assembly. After the distal anchors engage leaflets of the native heart valve, the retained portion of the replacement heart valve is released from the mid-shaft assembly and is allowed to fully expand.

Abstract: A flow restriction system may include an implantable controller system for controlling an implantable flow restrictor. The controller system may include: an implantable housing, an actuator at least partially disposed within the implantable housing, the actuator having a first configuration corresponding to the implantable flow restrictor being in the low profile state and a second configuration corresponding to the implantable flow restrictor being in the high profile pressure restricting state, an internal power source configured to supply current to the actuator, and a processor configured to control operation of the actuator using power from the internal power source.

Abstract: A method for remodeling a heart chamber. A catheter system can be used to deliver implants to the heart chamber. A user can use a handle to adjust the tension of sutures between the implants to adjust the size of the heart chamber. The heart chamber can be remodeled at specific dimensions to address cardiomyopathy in a patient-specific manner.

Abstract: A system and method for increasing cardiac output of a heart patient and/or diuresis is disclosed. The system can include a fluid pump with an expandable housing and an impeller. The impeller can be non-obstructive to at least some blood flowing between impeller blades of the impeller. The impeller can be housed in an expandable housing that is open to incoming flow which also reduces obstruction to blood flow. The fluid pump can be placed within and powered to rotate an impeller of the fluid pump in a first direction. The fluid pump can be switched to an unpowered state. In the unpowered state the impeller can be rotated by blood flowing through the fluid pump to reduce the obstructive effect of the impeller and/or to engage a power generating and/or physiologic conditions sensing mode.

Abstract: The present disclosure generally relates to implantable medical devices, and, in some embodiments, to a prosthetic implant. Such implantable devices may be, in some cases, useful in the treatment of acute aortic dissections (AADs). In some embodiments, the prosthetic implant comprises an inner frame and an outer frame, the inner frame comprising an expandable support structure. The expandable support structure may comprise one or more expandable branches. The expandable branch may comprise a proximal portion, a middle portion, and a distal portion configured to permit flattening, telescoping, pivoting, and/or expansion of the one or more portions of the expandable branch. The one or more expandable branches may be, in some cases, configured to be placed into a vessel, e.g., a coronary artery. Additionally, a first expandable support structure comprising one or more expandable branches may be, in some cases, coupled to a second expandable support structure comprising one or more expandable branches.

Abstract: The present disclosure generally relates to prosthetic implants, prosthetic implant systems, and their methods of use, for example, for treating a dissection. The prosthetic implants contemplated herein comprise an expandable arch support structure comprising one or more expandable branches configured to be placed within one or more vessels. Certain aspects of the disclosure relate to methods for treating a dissection, e.g., an aortic dissection, using said prosthetic implants and implant systems. The methods comprise advancing one or more guidewires into an ascending aorta, a descending aorta, and/or one or more one or more vessels of an aortic root or aortic arch. The methods further comprise exposing one or more components of the expandable arch support structure from a sheath. In some cases, the exposed component is an expandable branch that is advanced into the one or more vessels of the aortic root or aortic arch, thus anchoring the implant to the native aorta.

Abstract: The present disclosure generally relates to implantable medical devices, and, in some embodiments, to a prosthetic aortic implant. Such implantable devices may be useful in the treatment of acute aortic dissections (AADs). related systems and methods are also provided. In some embodiments, the prosthetic aortic implant comprises an expandable support structure and at least a first portion sized and configured to be positioned within an ascending portion of a native aorta of a subject. In some embodiments, the first portion comprises a non-porous layer and a porous layer. In some embodiments, the first portion is sized and configured to engage an aortic root of the native aorta. In some embodiments, the prosthetic aortic implant is designed and configured to engage with and/or receive an aortic valve implant.

Abstract: A system for percutaneous ventriculoplasty. Anchors can be placed in the ventricular septum and the ventricular wall. Sutures tethered to the anchors can be tensioned to reduce the size of a dilated left ventricle. Multiple anchors can be positioned in the ventricular wall and the sutures can be independently tensioned to allow tailored treatment of the dilated ventricle.

Abstract: Methods of delivering a replacement heart valve to a native heart valve and securing the replacement heart valve relative to a native heart valve annulus supporting native valve leaflets are disclosed. Some methods include delivering a replacement heart valve mounted on a delivery device to the native heart valve annulus while the replacement heart valve is in a radially compacted state. The replacement heart valve can comprise a radially expandable frame. Methods can include positioning the replacement valve so that at least a portion of the plurality of anchors are on a ventricular side of the native leaflets. Methods can also include releasing at least a portion of the replacement heart valve from the delivery device to thereby expand the plurality of anchors radially outwardly, and/or engaging at least the portion of the plurality of anchors with tissue on the ventricular side of the native heart valve annulus.

Abstract: A method for remodeling a heart chamber. A catheter system can be used to deliver implants to the heart chamber. A user can use a handle to adjust the tension of sutures between the implants to adjust the size of the heart chamber. The heart chamber can be remodeled at specific dimensions to address cardiomyopathy in a patient-specific manner.

Abstract: A vascular implant for replacing a native heart valve comprises a self expanding stent supporting a valve body having leaflets. The stent preferably comprises an anchoring structure configured to prevent the implant from passing through the valve annulus. For delivery, the implant is compacted within delivery device and secured at one end. During delivery the implant is partially released from the delivery device, and positioning of the implant can be verified prior to full release. The implant can be at least partially resheathed and repositioned if desired.

Abstract: A system for implanting a replacement heart valve at a native valve location between an atrium and a ventricle of a patient includes a replacement valve having an expandable frame and a plurality of prosthetic valve leaflets positioned within the expandable frame. A delivery device is provided for delivering the replacement heart valve to the native valve location. The delivery device includes an elongate inner tube having an inner retention ring for coupling to and end of the replacement heart valve and an outer support tube slidable over the inner retention ring for securing the replacement heart valve to the inner retention ring. The inner retention ring preferably includes slots for receiving struts of the expandable frame. The expandable frame preferably includes a plurality of anchors extending from the downstream portion in an upstream direction for extending between chordae and for placement outside of the native leaflets.