Abstract: Disclosed herein are representative embodiments of methods, apparatus, and systems used to deliver a prosthetic heart valve to a deficient valve. In one embodiment, for instance, a support structure and an expandable prosthetic valve are advanced through the aortic arch of a patient using a delivery system. The support structure is delivered to a position on or adjacent to the surface of the outflow side of the aortic valve (the support structure defining a support-structure interior). The expandable prosthetic valve is delivered into the aortic valve and into the support-structure interior. The expandable prosthetic heart valve is expanded while the expandable prosthetic heart valve is in the support-structure interior and while the support structure is at the position on or adjacent to the surface of the outflow side of the aortic valve, thereby causing one or more native leaflets of the aortic valve to be frictionally secured between the support structure and the expanded prosthetic heart valve.

Abstract: Disclosed herein is an expandable sheath that can be used in conjunction with a catheter assembly to introduce a prosthetic device, such as a heart valve, into a patient. The disclosed herein sheath can minimize trauma to the vessel by allowing for temporary expansion of a portion of the introducer sheath to accommodate the delivery apparatus, followed by a return to the original diameter once the prosthetic device passes through. Some aspects can include a sheath comprising an inner layer comprising a reinforcing layer comprising a plurality of struts that can be encapsulated within a polymer layer comprising a tether portion and an outer layer disposed over the inner layer. The disclosed sheath is configured to locally expand from a predetermined first diameter d1 to an expanded second diameter d2 during application of a radial outward force by passage of a medical device through the sheath.

Abstract: Aspects of an expandable sheath can be used in conjunction with a catheter assembly to introduce a prosthetic device, such as a heart valve, into a patient. Such aspects can minimize trauma to the vessel by allowing for temporary expansion of a portion of the introducer sheath to accommodate the delivery apparatus, followed by a return to the original diameter once the prosthetic device passes through. Some aspects can include a sheath comprising an inner layer comprising a reinforcing layer rolled into a spiral slidable configuration and encapsulated within a polymer layer comprising a tether portion and an outer layer disposed over the inner layer. The disclosed sheath is configured to locally expand from a predetermined first diameter d1 to an expanded second diameter d2 during application of a radial outward force by passage of the medical device through the sheath.

Abstract: Disclosed herein are representative embodiments of methods, apparatus, and systems used to deliver a prosthetic heart valve assembly. In embodiments, a prosthetic heart valve assembly, including a self-expandable support structure and a self-expanding heart valve, are advanced through the aortic arch of a patient using a delivery system. The support structure, which includes a plurality leaflet retaining arms, is at least partially expanded and positioned on or adjacent to the outflow side of the aortic valve. The prosthetic heart valve is positioned in the aortic valve. The prosthetic heart valve is expanded while it is within an interior of the support structure and while the support structure is positioned on or adjacent to the outflow side of the aortic valve, thereby causing one or more native leaflets of the aortic valve to be frictionally secured between the arms of the support structure and the expanded prosthetic heart valve.

Abstract: A method and apparatus for delivery of cell therapies, introduced via percutaneous access to the circulation, and delivered to the site of vascular injury or intervention.

Abstract: Disclosed herein are representative embodiments of methods, apparatus, and systems used to deliver a prosthetic heart valve assembly. In embodiments, a prosthetic heart valve assembly, including a self-expandable support structure and a self-expanding heart valve, are advanced through the aortic arch of a patient using a delivery system. The support structure, which includes a plurality leaflet retaining arms, is at least partially expanded and positioned on or adjacent to the outflow side of the aortic valve. The prosthetic heart valve is positioned in the aortic valve. The prosthetic heart valve is expanded while it is within an interior of the support structure and while the support structure is positioned on or adjacent to the outflow side of the aortic valve, thereby causing one or more native leaflets of the aortic valve to be frictionally secured between the arms of the support structure and the expanded prosthetic heart valve.

Abstract: A valve repair delivery handle includes a housing, an actuation control mechanism, and a clasp control mechanism. The actuation control mechanism includes a knob and an actuation tube. The knob is rotatably coupled to the housing. The actuation tube is coupled to the knob such that rotation of the knob in a first direction moves the actuation tube distally relative to the housing and rotation of the knob in a second direction moves the actuation tube proximally relative to the housing. The clasp control mechanism is coupled to the housing.

Abstract: An implantable prosthetic device can include a spacer member, a plurality of anchors, and a plurality of clasps. The spacer member can be configured to be disposed between native leaflets of a heart. The anchors can be coupled to the spacer member and configured to secure the native leaflets against the spacer member. The clasps can be coupled to a respective anchor and configured to secure the native leaflets to the anchors. The clasps can be independently movable between an open configuration and a closed configuration.

Abstract: A delivery system includes an elongate shaft, a handle, a first clasp control member, and a second clasp control member. The handle is connected to a proximal portion of the elongate shaft. The first and second clasp control members each extend into a distal portion of the elongate shaft, through at least a portion of the elongate shaft, out of the proximal portion of the elongate shaft, and through the handle. The first and second clasp control members have paths that include a first parallel portion in the elongate shaft where the first clasp control member and the second clasp control member are parallel, and a diverging portion that is proximal to the first parallel portion where the first clasp control member diverges from the second clasp control member.

Abstract: A delivery system includes an elongate shaft, a handle, a first clasp control member, and a second clasp control member. The handle is connected to a proximal portion of the elongate shaft. The first and second clasp control members each extend into a distal portion of the elongate shaft, through at least a portion of the elongate shaft, out of the proximal portion of the elongate shaft, and through the handle. The first and second clasp control members have paths that include a first parallel portion in the elongate shaft where the first clasp control member and the second clasp control member are parallel, and a diverging portion that is proximal to the first parallel portion where the first clasp control member diverges from the second clasp control member.

Abstract: An implantable heart valve device has a main body including a first end portion and a second end portion. The main body is configured to be implanted around a native leaflet of a heart valve such that the first end portion is on an atrial side of the leaflet and the second end portion is on a ventricular side of the leaflet, and such that the main body can coapt with an opposing native leaflet during operation of the heart valve. One of the first or second end portions comprises a coupling assembly, and the other of the first or second end portions comprises a coupling member configured to extend through the native leaflet when the heart valve device is implanted in a heart valve. The coupling assembly is configured to releasably engage the coupling member to permit adjustment of the relative positions of the first and second end portions.

Abstract: A delivery system includes an elongate shaft, a handle, a first clasp control member, a second clasp control member, and an actuator. The handle is connected to a proximal portion of the elongate shaft. The first and second clasp control members each extend into a distal portion of the elongate shaft, through at least a portion of the elongate shaft, out of the proximal portion of the elongate shaft, and through the handle. The actuator is coupled to the handle and has a first side portion connected to the first clasp control and a second side portion connected to the second clasp control.

Abstract: A delivery system includes an elongate shaft, a handle, a first clasp control member, a second clasp control member, and an actuator. The handle is connected to a proximal portion of the elongate shaft. The first and second clasp control members each extend into a distal portion of the elongate shaft, through at least a portion of the elongate shaft, out of the proximal portion of the elongate shaft, and through the handle. The actuator is coupled to the handle and has a first side portion connected to the first clasp control and a second side portion connected to the second clasp control.

Abstract: Disclosed herein are representative embodiments of methods, apparatus, and systems used to deliver a prosthetic heart valve to a deficient valve. In one embodiment, for instance, a support structure and an expandable prosthetic valve are advanced through the aortic arch of a patient using a delivery system. The support structure is delivered to a position on or adjacent to the surface of the outflow side of the aortic valve (the support structure defining a support-structure interior). The expandable prosthetic valve is delivered into the aortic valve and into the support-structure interior. The expandable prosthetic heart valve is expanded while the expandable prosthetic heart valve is in the support-structure interior and while the support structure is at the position on or adjacent to the surface of the outflow side of the aortic valve, thereby causing one or more native leaflets of the aortic valve to be frictionally secured between the support structure and the expanded prosthetic heart valve.

Abstract: Representative embodiments of methods, apparatus, and systems used to deliver a prosthetic heart valve to a deficient valve are disclosed. In one embodiment, for instance, a support structure and an expandable prosthetic valve are delivered to a position on or adjacent to the surface of the outflow side of the aortic valve (the support structure defining a support-structure interior) via a delivery system. The expandable prosthetic valve is delivered into the aortic valve and into the support-structure interior. The expandable, prosthetic heart valve is expanded while the expandable prosthetic heart valve is in the support-structure interior and while the support structure is at the position on or adjacent to the surface of the outflow side of the aortic valve, thereby causing one or more native leaflets of the aortic valve to be frictionally secured between the support structure and the expanded prosthetic heart valve.

Abstract: A mitral valve repair system includes a delivery sheath, a mitral valve repair device, and an actuator. The mitral valve repair device is disposed in the delivery sheath in an extended condition. The mitral valve repair device includes a pair of barbed clasps. The barbed clasps are in a closed condition while the mitral valve repair device is in the extended condition in the delivery sheath.

Abstract: A mitral valve repair system includes a delivery sheath, a mitral valve repair device, and an actuator. The mitral valve repair device is disposed in the delivery sheath in an extended condition. The mitral valve repair device is movable out of the delivery sheath while in the extended condition. The actuator is coupled to the mitral valve repair device, such that retracting the actuator reduces a length of the mitral valve repair device from the extended condition.

Abstract: A pair of paddles are moved laterally away from one another in an exemplary method of repairing a native valve of a patient during a non-open-heart procedure. After the paddles are moved laterally away from one another, first and second gripping members are moved from an open position to a closed position to grasp valve leaflets. The paddles are then moved laterally toward one another. A cam can be used to move the paddles away from one another.

Abstract: An exemplary valve repair system for repairing a native valve of a patient during a non-open-heart procedure has a delivery device and a valve repair device. The valve repair device is configured to be delivered through a lumen of the delivery device and to attach to a native valve of a patient. The valve repair device has first and second paddles and first and second gripping members. The first and second paddles are movable between an open position and a closed position. The first gripping member is attached to the first paddle and the second gripping member is attached to the second paddle. The gripping members are configured to attach to the native valve of the patient. A gripper control mechanism is configured to separately move the first and second gripping members.

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.