Abstract: Intravascular devices and methods for intramural delivery of dissection fluids and infusates are disclosed herein. In some embodiments, the systems include an infusion assembly that can access a position in vessel adjacent an infusion site and advance a tissue manipulation component into the infusion site to deliver a therapeutic infusate. The infusion site can be an intraluminal space, such as within an obstructive material, adjacent the obstructive material, and/or within a boundary layer between the obstructive material and a vessel wall. The infusion assembly can further deliver an infusate that includes a therapeutic drug or other agent into the infusion site.

Abstract: According to some embodiments, the present technology includes device for removing obstructive material from a blood vessel lumen. For example, the device can comprise an elongated member, a cutting portion carried by a distal region of the elongated member, and a capture portion carried by the distal region of the elongated member. The cutting portion can comprise a blade configured to separate at least a portion of the obstructive material from the blood vessel wall, and the capture portion can comprise a mesh structure configured to enmesh and/or capture at least a portion of the obstructive material.

Abstract: Intravascular devices and methods for intramural delivery of dissection fluids and infusates are disclosed herein. In some embodiments, the systems include an infusion assembly that can access a vessel wall at a depth within a layer of the vessel wall and advance a tissue manipulation component at approximately the same depth within the vessel wall to create an intramural space within the vessel layer. The infusion assembly can further deliver an infusate that includes a therapeutic drug or other agent into the intramural space.

Abstract: Endovascular valve formation systems with imaging capabilities and associated devices and methods are disclosed herein. In some embodiments, a valve formation and imaging system can include, for example, (i) a valve formation device configured to access a vessel wall and dissect a portion of the vessel wall to form an autologous valve leaflet and (ii) an imaging device configured to image the vessel wall and components of the valve formation device during a valve formation procedure. In some embodiments, the imaging device is integrated into a distal end portion of the valve formation device. In some embodiments, the imaging device is a separate catheter device positionally coupled to the valve formation device and/or components thereof.

Abstract: System for fixation of leaflets of a heart valve including a delivery catheter having an elongated shaft, a proximal end portion and a distal end portion configured to be positioned proximate native leaflets of a heart valve from a remote vascular access point, the delivery catheter further includes a rotatable actuator rod having a threaded fastener at a distal end thereof, and a fixation device releasably coupled by a threaded connection to the threaded fastener of the actuator rod. The fixation device includes a first arm moveable between a closed position and an open position, a second arm moveable between a closed position and an open position.

Abstract: The invention provides devices, systems and methods for tissue approximation and repair at treatment sites. The devices, systems and methods of the invention will find use in a variety of therapeutic procedures, including endovascular, minimally-invasive, and open surgical procedures, and can be used in various anatomical regions, including the abdomen, thorax, cardiovascular system, heart, intestinal tract, stomach, urinary tract, bladder, lung, and other organs, vessels, and tissues. The invention is particularly useful in those procedures requiring minimally-invasive or endovascular access to remote tissue locations, where the instruments utilized must negotiate long, narrow, and tortuous pathways to the treatment site. In addition, many of the devices and systems of the invention are adapted to be reversible and removable from the patient at any point without interference with or trauma to internal tissues.

Abstract: System for fixation of leaflets of a heart valve including a delivery catheter having an elongated shaft, a proximal end portion and a distal end portion configured to be positioned proximate native leaflets of a heart valve from a remote vascular access point, the delivery catheter further includes a rotatable actuator rod having a threaded fastener at a distal end thereof, and a fixation device releasably coupled by a threaded connection to the threaded fastener of the actuator rod. The fixation device includes a first arm moveable between a closed position and an open position, a second arm moveable between a closed position and an open position.

Abstract: System for fixation of leaflets of a heart valve including a delivery catheter having an elongated shaft, a proximal end portion and a distal end portion configured to be positioned proximate native leaflets of a heart valve from a remote vascular access point, the delivery catheter further includes a rotatable actuator rod having a threaded fastener at a distal end thereof, and a fixation device releasably coupled by a threaded connection to the threaded fastener of the actuator rod. The fixation device includes a first arm moveable between a closed position and an open position, a second arm moveable between a closed position and an open position.

Abstract: The present invention provides methods and devices for grasping, and optional repositioning and fixation of the valve leaflets to treat cardiac valve regurgitation, particularly mitral valve regurgitation. Such grasping will typically be atraumatic providing a number of benefits. For example, atraumatic grasping may allow repositioning of the devices relative to the leaflets and repositioning of the leaflets themselves without damage to the leaflets. However, in some cases it may be necessary or desired to include grasping which pierces or otherwise permanently affects the leaflets. In some of these cases, the grasping step includes fixation.

Abstract: System for fixation of leaflets of a heart valve including a delivery catheter having an elongated shaft, a proximal end portion and a distal end portion configured to be positioned proximate native leaflets of a heart valve from a remote vascular access point, the delivery catheter further includes a rotatable actuator rod having a threaded fastener at a distal end thereof, and a fixation device releasably coupled by a threaded connection to the threaded fastener of the actuator rod. The fixation device includes a first arm moveable between a closed position and an open position, a second arm moveable between a closed position and an open position.

Abstract: System for fixation of leaflets of a heart valve including an implantable fixation device including a first distal element and a second distal element, a first proximal element moveable relative to the first distal element between a first position and a second position, and a second proximal element moveable relative to the second distal element between a first position and a second position. The system further includes a delivery device including a catheter having a proximal end portion and a distal end portion, the implantable fixation device releasably coupled to the distal end portion of the catheter, the catheter defining at least one lumen extending between the proximal end portion and the distal end portion.

Abstract: System for fixation of leaflets of a heart valve including a delivery catheter having an elongated shaft, a proximal end portion and a distal end portion configured to be positioned proximate native leaflets of a heart valve from a remote vascular access point, the delivery catheter further includes a rotatable actuator rod having a threaded fastener at a distal end thereof, and a fixation device releasably coupled by a threaded connection to the threaded fastener of the actuator rod. The fixation device includes a first arm moveable between a closed position and an open position, and a second arm moveable between a closed position and an open position.

Abstract: System for fixation of leaflets of a heart valve including a delivery catheter having an elongated shaft, a proximal end portion and a distal end portion configured to be positioned proximate native leaflets of a heart valve from a remote vascular access point, and a fixation device releasably coupled to the delivery catheter. The fixation device includes a first arm moveable between a closed position and an open position, and a second arm moveable between a closed position and an open position. The fixation device further includes a first gripping element movable relative to the first arm in the open position, the first gripping element biased toward the first arm to capture a first leaflet of the heart valve therebetween, and a second gripping element movable relative to the second arm in the open position, the second gripping element biased toward the second arm to capture a second leaflet of the heart valve therebetween.

Abstract: The present invention provides methods and devices for grasping, and optional repositioning and fixation of the valve leaflets to treat cardiac valve regurgitation, particularly mitral valve regurgitation. Such grasping will typically be atraumatic providing a number of benefits. For example, atraumatic grasping may allow repositioning of the devices relative to the leaflets and repositioning of the leaflets themselves without damage to the leaflets. However, in some cases it may be necessary or desired to include grasping which pierces or otherwise permanently affects the leaflets. In some of these cases, the grasping step includes fixation.

Abstract: The present invention provides methods and devices for grasping, and optional repositioning and fixation of the valve leaflets to treat cardiac valve regurgitation, particularly mitral valve regurgitation. Such grasping will typically be atraumatic providing a number of benefits. For example, atraumatic grasping may allow repositioning of the devices relative to the leaflets and repositioning of the leaflets themselves without damage to the leaflets. However, in some cases it may be necessary or desired to include grasping which pierces or otherwise permanently affects the leaflets. In some of these cases, the grasping step includes fixation.

Abstract: System for fixation of leaflets of a heart valve including an implantable fixation device including a first distal element and a second distal element, a first proximal element moveable relative to the first distal element between a first position and a second position, and a second proximal element moveable relative to the second distal element between a first position and a second position. The system further includes a delivery device including a catheter having a proximal end portion and a distal end portion, the implantable fixation device releasably coupled to the distal end portion of the catheter, the catheter defining at least one lumen extending between the proximal end portion and the distal end portion.

Abstract: System for fixation of leaflets of a heart valve including a delivery catheter having an elongated shaft, a proximal end portion and a distal end portion configured to be positioned proximate native leaflets of a heart valve from a remote vascular access point, and a fixation device releasably coupled to the delivery catheter. The fixation device includes a first arm moveable between a closed position and an open position, and a second arm moveable between a closed position and an open position. The fixation device further includes a first gripping element movable relative to the first arm in the open position, the first gripping element biased toward the first arm to capture a first leaflet of the heart valve therebetween, and a second gripping element movable relative to the second arm in the open position, the second gripping element biased toward the second arm to capture a second leaflet of the heart valve therebetween.

Abstract: System for fixation of leaflets of a heart valve including a delivery catheter having an elongated shaft, a proximal end portion and a distal end portion configured to be positioned proximate native leaflets of a heart valve from a remote vascular access point, the delivery catheter further includes a rotatable actuator rod having a threaded fastener at a distal end thereof, and a fixation device releasably coupled by a threaded connection to the threaded fastener of the actuator rod. The fixation device includes a first arm moveable between a closed position and an open position, and a second arm moveable between a closed position and an open position.

Abstract: System for fixation of leaflets of a heart valve including a delivery catheter having an elongated shaft, a proximal end portion and a distal end portion configured to be positioned proximate native leaflets of a heart valve from a remote vascular access point, the delivery catheter further includes a rotatable actuator rod having a threaded fastener at a distal end thereof, and a fixation device releasably coupled by a threaded connection to the threaded fastener of the actuator rod. The fixation device includes a first arm moveable between a closed position and an open position, a second arm moveable between a closed position and an open position.

Abstract: The methods, devices, and systems are provided for performing endovascular repair of atrioventricular and other cardiac valves in the heart. Regurgitation of an atrioventricular valve, particularly a mitral valve, can be repaired by modifying a tissue structure selected from the valve leaflets, the valve annulus, the valve chordae, and the papillary muscles. These structures may be modified by suturing, stapling, snaring, or shortening, using interventional tools which are introduced to a heart chamber. The tissue structures can be temporarily modified prior to permanent modification. For example, opposed valve leaflets may be temporarily grasped and held into position prior to permanent attachment. In one aspect, a structure is deployed in a gutter region of the valve annulus to modify the shape of the valve.