Abstract: An apparatus for delivering a prosthetic device through the vasculature of a patient includes a radially expandable member coupled to the distal end of an elongate shaft. The expandable member has an open frame configuration and an outer mounting surface for mounting the prosthetic device in a collapsed state thereon. The expandable member expands radially outwards from a first configuration to a second configuration to expand a prosthetic device mounted thereon.

Abstract: A method of implanting a balloon expandable prosthetic valve within a native aortic valve includes introducing a delivery system into a femoral artery of a patient, the delivery system comprising an outer sleeve and a shaft extending through a lumen of the outer sleeve. A distal end portion of the shaft is positioned distal to a distal end of a steerable distal end portion of the outer sleeve. A prosthetic valve is crimped over a balloon disposed along the distal end portion of the shaft. The delivery system further comprises a first radiopaque marker inside the balloon and positioned adjacent a proximal end of the prosthetic valve and a second radiopaque marker inside the balloon and positioned adjacent a distal end of the prosthetic valve. The method also includes identifying a location of the prosthetic valve by monitoring the first and second radiopaque markers inside the balloon under fluoroscopy.

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: A valve repair system for repairing a native valve of a patient includes a catheter and a valve repair device. The valve repair device is disposed in the catheter. The valve repair device comprises a compressible spacer and a pair of paddles. The pair of paddles are moveable between an open position and a closed position. The valve repair device can transition to a compressed configuration with the compressible spacer between the pair of paddles in the closed position.

Abstract: An assembly for delivering a prosthetic heart valve to a native heart valve is disclosed. The assembly includes a self-expanding prosthetic heart valve formed with an expandable metallic stent and a flexible valvular structure. The assembly also includes a delivery apparatus having a delivery sleeve. The delivery sleeve includes a selectively steerable section and a distal portion for retaining the prosthetic heart valve in a compressed state. A handle is coupled to a proximal end of the delivery sleeve and a pull wire extends from the handle to the steerable section of the delivery sleeve. The handle preferably includes a rotatable portion for actuating the pull wire and thereby selectively controlling a curvature of the steerable section during advancement through the patient's vasculature. In preferred embodiments, the steerable section includes a flexible metallic tubular portion formed with a plurality of circumferentially extending openings.

Abstract: A valve repair devices and systems for repairing a native valve of a patient include a spacer, a pair of paddles, and a pair of moveable clasp arms. The pair of moveable clasp arms are disposed between the pair of paddles and the spacer. The moveable clasp arms are configured to attach to leaflets of a heart valve. The spacer, the pair of paddles, and the moveable clasp arms are configured such that, when attached to the leaflets, the moveable clasp arms are located between the spacer and first portions of the leaflet, while second portions of the leaflet engage the spacer.

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 valve repair device includes a pair of gripping members that are configured to attach to the native valve of the patient. A gripper control mechanism is configured to independently engage and move each of the gripping members.

Abstract: An exemplary valve repair device for repairing a native valve of a patient has a pair of paddles, a pair of gripping members, and at least one latch member. The paddles are movable between an open position and a closed position. The paddles and/or the gripping members are configured to attach to the native valve of the patient. When the paddles are in the closed position, the latch members latch the paddles in the closed position.

Abstract: An exemplary valve repair device for repairing a native valve of a patient includes a pair of paddles, a coaption element, and a covering. The coaption element has a first end portion and a second end portion. The coaption element is connected to the pair of paddles. The covering is disposed over the caption element. The covering prevents blood from flowing through the caption element.

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 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: An exemplary implantable prosthetic device has a paddle frame, an inner paddle, and an outer paddle. The outer paddle is connected to the inner paddle. The inner and outer paddles are connected to the paddle frame at a connection between the inner paddle and the outer paddle. The paddle frame can be positioned inside the inner paddle, outside the outer paddle, or between the inner and outer paddles.

Abstract: An exemplary valve repair device for repairing a native valve of a patient has a cap, and a paddle. The paddle has an inner paddle portion and an outer paddle portion. The inner paddle portion and the outer paddle portion are formed from a continuous strip of metal fabric. The outer paddle portion is connected to the cap. The cap is moveable away from the inner paddle portion to open the paddle.

Abstract: A delivery catheter is in various embodiments configured to deliver an anchoring device to a native valve annulus of a patient's heart, where the anchoring device can better secure a prosthesis at the native annulus. The delivery catheter can includes a distal section that includes one or more spines or is laser cut to assume a particular shape for better facilitating delivery of the anchoring device at the implant site and can include a flexible tube, a first pull wire, and a second pull wire. The flexible tube can comprise a bore extending between the first end and the second end sized for passing the anchoring device therethrough. The distal portion can comprise a first flexing section and a second flexing section. Actuation of the first pull wire and the second pull wire can cause the flexible tube to move from a first configuration to a second configuration.

Abstract: In a representative embodiment, a method comprises implanting first and second inflatable bodies within an annulus of a native heart valve by securing the inflatable bodies to tissue of the native heart valve with sutures, and implanting a prosthetic heart valve between the inflatable bodies such that the prosthetic heart valve is retained within the annulus by the inflatable bodies.

Abstract: An exemplary valve repair device for repairing a native valve of a patient has a paddle frame, and inner and outer paddle portions formed from a strip of metal fabric. The paddle frame has a round three-dimensional shape. The strip of metal fabric is attached to a closed attachment portion of the paddle frame.

Abstract: An exemplary valve repair device for repairing a native valve of a patient includes a coaption element, a collar, a pair of paddles, a cap, and a shaft. The coaption element has a first end portion and a second end portion. The collar is connected to the first end portion of the coaption element. The pair of paddles each include an inner paddle portion and an outer paddle portion that are movable between an open position, a closed position, and a bailout position. The cap is connected to the pair of paddles. The shaft extends through the collar and the coaption element and is connected to the cap. Movement of the cap by the shaft causes the inner paddle portions and the outer paddle portions of the pair of paddles to move between the open position, the closed position, and the bailout position. When the paddles are in the bailout position, a bailout angle between each inner paddle portion and the shaft is greater than or equal to 120 degrees.

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: 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: Embodiments of the present disclosure provide an introducer device and method for introducing a delivery apparatus into a patient's vasculature. Disclosed methods can include positioning a sleeve of an introducer sheath in a blood vessel of a patient, the sleeve having a lattice layer with a lumen therethrough, inserting a distal end portion of the delivery apparatus and a prosthetic heart valve into the lumen, and advancing the distal end portion of the delivery apparatus through the lumen from the proximal end to the distal end. The method can then include expanding the lumen from a first diameter smaller to a second diameter at least equal to the diameter of the prosthetic heart valve to allow passage of the prosthetic heart valve through the lumen, and returning the lumen of the sleeve to a diameter smaller than the second diameter after advancing the prosthetic heart valve through the lumen.