Abstract: The present disclosure concerns embodiments of an implantable device that are used to treat an insufficient heart valve that has been previously treated by implantation of a fixation device or an Alfieri stitch that is secured to opposing portions of the native leaflets. In one representative embodiment, an implantable device for remodeling a native mitral valve having two native leaflets and a fixation device or an Alfieri stitch secured to respective free edges of the leaflets is configured to be coupled to the fixation device or Alfieri stitch and apply a remodeling force to the native mitral valve that draws the native leaflets toward each other to promote coaptation of the leaflets.

Abstract: A method of using a device to improve the function of a heart valve is disclosed. In one preferred embodiment, the method includes positioning a prosthetic insert member between leaflets of mitral valve. The insert member has an elongated cross-sectional profile for conforming to gap between leaflets of a mitral valve. The device also includes an anchoring member for attachment to heart tissue for maintaining the insert member in the mitral valve. The insert member is used to plug the gap between the leaflets of the mitral valve and thereby reduce undesirable regurgitation while allowing the leaflets to function in a substantially normal manner. An anchoring member secures the prosthetic insert member to a heart wall. The anchoring member preferably includes a plurality of tissue penetrating hooks or prongs.

Abstract: Disclosed herein are devices for improving coaption of the mitral valve leaflets to reduce or eliminate mitral valve regurgitation. The devices may be used to perform mitral valve annuloplasty, or to serve as a docking station for a transcatheter prosthetic heart valve. The various embodiments of devices are configured for percutaneous and, in some cases, transvascular delivery. Delivery systems useful for routing the devices to the mitral valve are also disclosed, including catheters, balloons and/or mechanical expansion systems. The devices themselves include at least one tissue penetrating member. Methods of delivery include partially embedding the devices in the mitral valve annulus via at least one tissue penetrating member. Tissue penetrating members may be embedded into the tissue in a simultaneous or a nearly simultaneous fashion. Upon embedding, the devices employ various expansion and/or contraction features to adjust the mitral valve diameter.

Abstract: A device for reshaping the tricuspid valve comprises a stent that is deployed in the right ventricular outflow tract (RVOT) adjacent to the tricuspid valve and expanded to a size sufficient to reduce the annular diameter or size of the tricuspid valve, thereby improving coaptation of the leaflets and reducing regurgitation. Embodiments of the device are deliverable percutaneously.

Abstract: A medical device configured for placement in a blood vessel, in which an elastic tube extends between first and second expandable anchoring stents. The elastic tube is constructed of a resilient material that deflects outward in response to increased blood pressure of a heart beat and that moves back inward as the blood pressure drops, thereby aiding the heart's pumping action.

Abstract: An apparatus, system, and method for repairing openings such as septal defects includes advancing a catheter to the site of the defect, grasping opposing edges of the defect, passing one or more suture lines through the opposing edges, tightening the suture lines, and deploying and expanding a fastener to secure the suture lines and close the defect. The fastener can include tissue-growth-inducing materials to encourage tissue growth onto or into the fastener and/or suture. The fastener includes a locking clip portion and a plug portion, which may be an expandable portion and/or tissue-growth-inducing portion.

Abstract: A method of using a device to improve the function of a heart valve is disclosed. In one preferred embodiment, the method includes positioning a prosthetic insert member between leaflets of mitral valve. The insert member has an elongated cross-sectional profile for conforming to gap between leaflets of a mitral valve. The device also includes an anchoring member for attachment to heart tissue for maintaining the insert member in the mitral valve. The insert member is used to plug the gap between the leaflets of the mitral valve and thereby reduce undesirable regurgitation while allowing the leaflets to function in a substantially normal manner. An anchoring member secures the prosthetic insert member to a heart wall. The anchoring member preferably includes a plurality of tissue penetrating hooks or prongs.

Abstract: A medical device for treating aortic insufficiency (and associated aneurysms or defects of any other vessel associated with a valve) includes a support structure, a stent, a prosthetic valve and a deflector. Generally, the support structure is configured to cooperate with the prosthetic valve to pinch the native valve therebetween and provide an anchor for the stent which extends into the aorta and supports the deflector which is positioned to abate blood flow against the aneurysm.

Abstract: Methods and devices for increasing flow in the left atrial appendage (LAA) include a conduit directing blood flow from a pulmonary artery into the LAA and/or a conduit drawing blood from the LAA by a Bernoulli effect. In one embodiment, a method comprises implanting a conduit in a pulmonary vein, expanding an inlet portion such that the conduit becomes anchored within the vein and directs blood through an outlet portion of the conduit into or toward the left atrial appendage.

Abstract: Methods and devices for increasing flow in the left atrial appendage (LAA) include a conduit directing blood flow from a pulmonary artery into the LAA and/or a conduit drawing blood from the LAA by a Bernoulli effect. In one embodiment, a method comprises implanting a conduit in a pulmonary vein, expanding an inlet portion such that the conduit becomes anchored within the vein and directs blood through an outlet portion of the conduit into or toward the left atrial appendage.

Abstract: A method of using a device to improve the function of a heart valve is disclosed. In one preferred embodiment, the method includes positioning a prosthetic insert member between leaflets of mitral valve. The insert member has an elongated cross-sectional profile for conforming to gap between leaflets of a mitral valve. The device also includes an anchoring member for attachment to heart tissue for maintaining the insert member in the mitral valve. The insert member is used to plug the gap between the leaflets of the mitral valve and thereby reduce undesirable regurgitation while allowing the leaflets to function in a substantially normal manner. An anchoring member secures the prosthetic insert member to a heart wall. The anchoring member preferably includes a plurality of tissue penetrating hooks or prongs.

Abstract: A method of dissolving a thrombus in a blood vessel for improving blood flow is provided. A filter device includes an expandable filter body fixed to a distal end portion of an outer catheter. The filter device also includes an agitation member disposed along a distal end portion of an inner catheter, wherein the inner catheter is slidably contained within the outer catheter. During treatment, the expandable filter body is expanded within the blood vessel and the inner catheter is advanced relative to the outer catheter such that the agitation member is positioned distal to the filter body. The agitation member is activated for dissolving the thrombus in the blood vessel. After the thrombus is at least partially dissolved, aspiration may be applied for pulling resulting particles into the filter body. The filter device is then retracted into a delivery sheath with the particles captured inside the filter body.

Abstract: Embodiments of a method for implanting a prosthetic valve at the native mitral valve region of the heart, the prosthetic valve including a main body that is radially compressible to a radially compressed state and self-expandable from the compressed state to a radially expanded state. The prosthetic apparatus also comprises at least one ventricular anchor coupled to the main body and disposed outside of the main body with a leaflet-receiving space between the anchor and an outer surface of the main body to receive a native valve leaflet. Apparatus for delivering and implanting the prosthetic valve are also described.

Abstract: A prosthetic insert member for improving the function of a mitral valve is disclosed. The insert member is configured for insertion between leaflets of mitral valve. The insert member has an elongated cross-sectional profile for conforming to the opening in the mitral valve. The device also includes an anchoring member for attachment to heart tissue for maintaining the insert member in the mitral valve. In operation, the insert member fills the opening between the leaflets of the mitral valve and reduces regurgitation while preferably allowing the leaflets to function in a substantially normal manner. In one embodiment, the insert member is formed with a valve member disposed in a passageway for allowing blood to pass through the insert member in one direction.

Abstract: A method of dissolving a thrombus in a blood vessel for improving blood flow. A filter device includes an expandable filter body fixed to a distal end portion of an outer catheter. The filter device also includes an agitation member disposed along a distal end portion of an inner catheter, wherein the inner catheter is slidably contained within the outer catheter. During treatment, the expandable filter body is expanded within the blood vessel and the inner catheter is advanced relative to the outer catheter such that the agitation member is positioned distal to the filter body. The agitation member is activated for dissolving the thrombus in the blood vessel. After the thrombus is at least partially dissolved, aspiration is applied for pulling resulting particles into the filter body. The filter device is then retracted into a delivery sheath with the particles captured inside the filter body.

Abstract: An apparatus, system, and method for repairing openings such as septal defects includes advancing a catheter to the site of the defect, grasping opposing edges of the defect, passing one or more suture lines through the opposing edges, tightening the suture lines, and deploying and expanding a fastener to secure the suture lines and close the defect. The fastener can include tissue-growth-inducing materials to encourage tissue growth onto or into the fastener and/or suture. The fastener includes a locking clip portion and a plug portion, which may be an expandable portion and/or tissue-growth-inducing portion.

Abstract: Methods and devices for increasing flow in the left atrial appendage (LAA) include a conduit directing blood flow from a pulmonary artery into the LAA and/or a conduit drawing blood from the LAA by a Bernoulli effect. In one embodiment, a method comprises implanting a conduit in a pulmonary vein, expanding an inlet portion such that the conduit becomes anchored within the vein and directs blood through an outlet portion of the conduit into or toward the left atrial appendage.

Abstract: A device for reshaping the tricuspid valve comprises a stent that is deployed in the right ventricular outflow tract (RVOT) adjacent to the tricuspid valve and expanded to a size sufficient to reduce the annular diameter or size of the tricuspid valve, thereby improving coaptation of the leaflets and reducing regurgitation. Embodiments of the device are deliverable percutaneously.

Abstract: Embodiments of a method for implanting a prosthetic valve at the native mitral valve region of the heart, the prosthetic valve including a main body that is radially compressible to a radially compressed state and self-expandable from the compressed state to a radially expanded state. The prosthetic apparatus also comprises at least one ventricular anchor coupled to the main body and disposed outside of the main body with a leaflet-receiving space between the anchor and an outer surface of the main body to receive a native valve leaflet. Apparatus for delivering and implanting the prosthetic valve are also described.

Abstract: A method of dissolving a thrombus in a blood vessel for improving blood flow. A filter device includes an expandable filter body fixed to a distal end portion of an outer catheter. The filter device also includes an agitation member disposed along a distal end portion of an inner catheter, wherein the inner catheter is slidably contained within the outer catheter. During treatment, the expandable filter body is expanded within the blood vessel and the inner catheter is advanced relative to the outer catheter such that the agitation member is positioned distal to the filter body. The agitation member is activated for dissolving the thrombus in the blood vessel. After the thrombus is at least partially dissolved, aspiration is applied for pulling resulting particles into the filter body. The filter device is then retracted into a delivery sheath with the particles captured inside the filter body.