Abstract: A medical device for treating a native heart valve may include a frame formed of shape-memory material, the frame including a central bar extending between a first leg and a second leg of the frame. The frame may be transitionable between a delivery condition and a deployed condition. The first leg and the second leg may each having a curved portion with a concave outer surface in the deployed condition. The concave outer surface may be sized and shaped to engage a corresponding native commissure of the native heart valve so that, when the frame is deployed within the native heart valve, the central bar bridges across the native heart valve.

Abstract: Apparatus and methods are described herein for a secondary valve apparatus that can be deployed within an existing implanted prosthetic heart valve. In some embodiments, a secondary prosthetic heart valve apparatus is implanted in series with an existing deteriorating implanted prosthetic valve. The secondary valve apparatus can restore proper valve function without disruption to the failing previously implanted valve. In some embodiments, the secondary valve apparatus can be positioned on an atrial portion of the existing valve, and be delivered transseptally. In other embodiments, the secondary valve apparatus can be positioned at a ventricular portion of the existing valve and delivered transapically. Devices and methods to prepare the existing valve to receive a secondary valve apparatus are also described herein. In some embodiments, a balloon expansion device can be used to expand an inner diameter of the existing valve to provide space for the secondary valve to be disposed.

Abstract: In some embodiments, a method includes delivering to a native valve annulus (e.g., a native mitral valve annulus) of a heart a prosthetic heart valve (200) having a body (242) expandable from a collapsed, delivery configuration to an expanded, deployed configuration. The method can further include, after the delivering, causing the prosthetic heart valve to move from the delivery configuration to the deployed configuration. With the prosthetic heart valve in its deployed configuration, an anchoring tether (191) extending from the prosthetic heart valve can be secured to a wall (Vw) of the heart (H). An electrode (189) coupled to at least one of the prosthetic heart valve or the anchoring tether can then be used to at least one of pace the heart or sense a signal associated with the heart.

Abstract: In some embodiments, a method includes delivering to a native valve annulus (e.g., a native mitral valve annulus) of a heart a prosthetic heart valve having a body expandable from a collapsed, delivery configuration to an expanded, deployed configuration. The method can further include, after the delivering, causing the prosthetic heart valve to move from the delivery configuration to the deployed configuration. With the prosthetic heart valve in its deployed configuration, an anchor can be delivered and secured to at least one of a fibrous trigone of the heart or an anterior native leaflet of the native valve. With the prosthetic heart valve disposed in the native valve annulus and in its deployed configuration, an anchoring tether can extending from the anchor can be secured to a wall of the heart to urge the anterior native leaflet towards the body of the prosthetic heart valve.

Abstract: Devices, systems and methods for removal of a mitral valve clip and subsequent delivery of a mitral valve implantation in a mitral valve replacement procedure. A modular port accessory device having a distal connector configured to be compatible with corresponding connectors on an existing therapeutic device, wherein the port accessory can be selectively attached to a proximal end portion connector of a proximal end portion of a catheter assembly of an existing therapeutic device. The catheter assembly is introduced to a target site within the patient's anatomy, and remains in place throughout a multistep therapeutic procedure for use with other therapeutic devices, all while allowing hemostasis to be controlled during use ad interchange of multiple therapeutic devices.

Abstract: In some embodiments, a method includes delivering to a native valve annulus (e.g., a native mitral valve annulus) of a heart a prosthetic heart valve having a body expandable from a collapsed, delivery configuration to an expanded, deployed configuration. The method can further include, after the delivering, causing the prosthetic heart valve to move from the delivery configuration to the deployed configuration. With the prosthetic heart valve in its deployed configuration, an anchor can be delivered and secured to at least one of a fibrous trigone of the heart or an anterior native leaflet of the native valve. With the prosthetic heart valve disposed in the native valve annulus and in its deployed configuration, an anchoring tether can extending from the anchor can be secured to a wall of the heart to urge the anterior native leaflet towards the body of the prosthetic heart valve.

Abstract: Apparatus and methods are described herein for a secondary valve apparatus that can be deployed within an existing implanted prosthetic heart valve. In some embodiments, a secondary prosthetic heart valve apparatus is implanted in series with an existing deteriorating implanted prosthetic valve. The secondary valve apparatus can restore proper valve function without disruption to the failing previously implanted valve. In some embodiments, the secondary valve apparatus can be positioned on an atrial portion of the existing valve, and be delivered transseptally. In other embodiments, the secondary valve apparatus can be positioned at a ventricular portion of the existing valve and delivered transapically. Devices and methods to prepare the existing valve to receive a secondary valve apparatus are also described herein. In some embodiments, a balloon expansion device can be used to expand an inner diameter of the existing valve to provide space for the secondary valve to be disposed.

Abstract: In some embodiments, a method includes delivering to a native valve annulus (e.g., a native mitral valve annulus) of a heart a prosthetic heart valve (200) having a body (242) expandable from a collapsed, delivery configuration to an expanded, deployed configuration. The method can further include, after the delivering, causing the prosthetic heart valve to move from the delivery configuration to the deployed configuration. With the prosthetic heart valve in its deployed configuration, an anchoring tether (191) extending from the prosthetic heart valve can be secured to a wall (Vw) of the heart (H). An electrode (189) coupled to at least one of the prosthetic heart valve or the anchoring tether can then be used to at least one of pace the heart or sense a signal associated with the heart.

Abstract: In some embodiments, a method includes delivering to a native valve annulus (e.g., a native mitral valve annulus) of a heart a prosthetic heart valve having a body expandable from a collapsed, delivery configuration to an expanded, deployed configuration. The method can further include, after the delivering, causing the prosthetic heart valve to move from the delivery configuration to the deployed configuration. With the prosthetic heart valve in its deployed configuration, an anchor can be delivered and secured to at least one of a fibrous trigone of the heart or an anterior native leaflet of the native valve. With the prosthetic heart valve disposed in the native valve annulus and in its deployed configuration, an anchoring tether can extending from the anchor can be secured to a wall of the heart to urge the anterior native leaflet towards the body of the prosthetic heart valve.

Abstract: In some embodiments, a method includes delivering to a native valve annulus (e.g., a native mitral valve annulus) of a heart a prosthetic heart valve having a body expandable from a collapsed, delivery configuration to an expanded, deployed configuration. The method can further include, after the delivering, causing the prosthetic heart valve to move from the delivery configuration to the deployed configuration. With the prosthetic heart valve in its deployed configuration, an anchor can be delivered and secured to at least one of a fibrous trigone of the heart or an anterior native leaflet of the native valve. With the prosthetic heart valve disposed in the native valve annulus and in its deployed configuration, an anchoring tether can extending from the anchor can be secured to a wall of the heart to urge the anterior native leaflet towards the body of the prosthetic heart valve.

Abstract: In some embodiments, a method includes delivering to a native valve annulus (e.g., a native mitral valve annulus) of a heart a prosthetic heart valve having a body expandable from a collapsed, delivery configuration to an expanded, deployed configuration. The method can further include, after the delivering, causing the prosthetic heart valve to move from the delivery configuration to the deployed configuration. With the prosthetic heart valve in its deployed configuration, an anchor can be delivered and secured to at least one of a fibrous trigone of the heart or an anterior native leaflet of the native valve. With the prosthetic heart valve disposed in the native valve annulus and in its deployed configuration, an anchoring tether can extending from the anchor can be secured to a wall of the heart to urge the anterior native leaflet towards the body of the prosthetic heart valve.

Abstract: A guide wire comprising an elongate, flexible core having a proximal region, a proximal end, a distal region, and a distal end; and a plurality of wire strands wrapped helically parallel to one another and disposed on at least a portion of the distal region of the core.

Abstract: A method for securing a compliant scaffold to an outer surface of a vascular graft includes positioning the scaffold radially about an elongated support tube which includes first and second radially outwardly flared end portions respectively defining first and second open ends of the support tube. The method further includes pulling the vascular graft through a lumen of the support tube, and axially deploying the scaffold over the first end portion of the support tube and into compliant contact with the outer surface of the vascular graft.

Abstract: A guide wire comprising an elongate, flexible core having a proximal region, a proximal end, a distal region, and a distal end; and a plurality of wire strands wrapped helically parallel to one another and disposed on at least a portion of the distal region of the core.

Abstract: A guide wire comprising an elongate, flexible core having a proximal region, a proximal end, a distal region, and a distal end, and the distal region having a tapered portion; a plurality of wire strands wrapped helically parallel to one another and disposed on at least a portion of the tapered distal region of the core; a polymer tie layer disposed on at least a portion of the plurality of wire strands; and a lubricious polymer layer disposed on the polymer tie layer.

Abstract: A method for securing a compliant scaffold to an outer surface of a vascular graft includes positioning the scaffold radially about an elongated support tube which includes first and second radially outwardly flared end portions respectively defining first and second open ends of the support tube. The method further includes pulling the vascular graft through a lumen of the support tube, and axially deploying the scaffold over the first end portion of the support tube and into compliant contact with the outer surface of the vascular graft.

Abstract: A guide wire including a lubricous distal portion and a less lubricous intermediate portion proximal of said distal portion. One guide wire provides a highly lubricous distal portion with a hydrophilic layer and a less lubricous intermediate portion with a hydrophobic layer. Another guide wire provides a lubricous distal portion with a polymer tip that is itself hydrophilic. Yet another guide wire provides a less lubricous intermediate portion using a stainless steel coil helically wound around the tapering intermediate portion. The coil is preferably coated with a hydrophobic coating such as PTFE or silicone. The coil can either abut the distal portion proximal end or extend into the distal portion interior.

Abstract: Devices and methods for detecting vulnerable plaque within a blood vessel are disclosed. A system in accordance with the present invention includes a first wire having a distal end coupled to a voltage source and a proximal end coupled to an instrument capable of measuring voltage. A distal end of a second wire is also coupled to the voltage source and a proximal end of the second wire is coupled to the instrument. The amplitude of the electromotive force produced by the voltage source preferably varies with the temperature of a tissue proximate the voltage source.

Abstract: Devices and methods for detecting vulnerable plaque within a blood vessel are disclosed. A system in accordance with the present invention includes a first wire having a distal end coupled to a voltage source and a proximal end coupled to an instrument capable of measuring voltage. A distal end of a second wire is also coupled to the voltage source and a proximal end of the second wire is coupled to the instrument. The amplitude of the electromotive force produced by the voltage source preferably varies with the temperature of a tissue proximate the voltage source.

Abstract: A radiation source for inhibiting restenosis including a radiation delivery tube having a radioactive distal region, the tube being adapted to slide over a guide wire within a radiation delivery catheter. One tube has radioactive material incorporated into the tube wall material. Another tube has radioactive material secured to the tube surface. One radiation delivery balloon catheter includes a common inflation and radiation delivery lumen, the lumen being sealed distally and having a radiation source guide wire within the lumen. The lumen is sealed from contact with bodily fluids and is filled with inflation fluid during use. In use, the catheter balloon is advanced to a site to be treated, the balloon inflated, and the radioactive tube advanced over the radiation source guide wire within the lumen.