Abstract: A crimping device used with a medical device can include at least one force-applying surface configured to compress the medical device by applying a force to a surface of the medical device. The crimping device also includes at least one protruding element extending from the force-applying surface and arranged to least partially extend into one of the openings defined by frame struts while the medical device is being crimped. The extension of the at least one protruding element at least partially into one of the openings prevents at least a portion of the soft layer of the medical device from protruding between struts of the outer frame of the medical device while the device is being crimped.

Abstract: A catheter includes an elongate shaft including a proximal portion and a distal portion extending from the proximal portion to a distal opening at a distal end of the shaft. The proximal portion defines a proximal guidewire lumen and has a first outer diameter. The distal portion defines a distal guidewire lumen in communication with the proximal guidewire lumen and has a second outer diameter smaller than the first outer diameter. A pressure sensor is coupled to the proximal portion such that the pressure sensor faces the proximal guidewire lumen. When the catheter is tracked to a treatment site within the vasculature, the pressure sensor is disposed proximal the treatment site, the distal opening is disposed distal to the treatment site, and the distal guidewire lumen fills with blood such that the pressure sensor senses a pressure of the blood at the distal end of the shaft.

Abstract: A profile altering tip is provided for a delivery system. The tip defines a first profile with a generally conical shape and a second profile with a generally round shape. During use of the delivery system, a tip profile control assembly can alter the tip from the first profile to the second profile.

Abstract: The delivery systems disclosed herein can create simultaneous movement of an inner and an outer sheath of the delivery system. The delivery systems can generally include a handle assembly and a delivery catheter. In certain embodiments, the inner shaft and the outer sheath can be slidably controlled by a control element in the handle. The handle assembly can include a housing with a thumbwheel acting as the control element. In certain embodiments, movement of the inner shaft and the outer sheath can be caused via a gear-type system. In certain embodiments, the handle assembly can include a rotatable housing. A control element can rotate the housing, which can cause a first boss associated with the outer sheath and a second boss associated with the inner shaft to move in opposite directions.

Abstract: A prosthetic heart valve including a stent frame and a valve structure. The valve structure is disposed within a lumen of the stent frame. The stent frame is configured to self-expand from a compressed condition for transluminal delivery. The stent frame has a lattice structure forming a tubular shape defining a circumference and a plurality of closed cells arranged to define a band exhibiting a variable radial stiffness. The prosthesis can be deployed such that the band applies a minimal force on to anatomical locations relating to the heart's conductive pathways. A region of the band otherwise having low radial stiffness is located at or over a conductive pathway upon final implant.

Abstract: A catheter is disclosed for providing pressure measurements at a vascular lesion. The catheter includes an outer component having a side opening the providing transverse access to a lumen thereof and an inner component slidably disposed within the lumen. The inner component has a guidewire lumen with a proximal side port. When the inner component is longitudinally translated relative to the outer component, the side port of the inner component is accessible through the side opening of the outer component for providing transverse access to a guidewire. A first pressure sensor is disposed proximate of a distal end of the outer component and a second pressure sensor is disposed proximate of a distal end of the inner component, such that relative longitudinal translation between the inner and outer components permits a distance between the first and second pressure sensors to be varied.

Abstract: Embodiments hereof relate to methods and systems for determining a pressure gradient across a lesion of a vessel without requiring the use of a pharmacological hyperemic agent. A measurement system includes at least an injection catheter and a pressure-sensing instrument or guidewire slidingly disposed through the catheter, the pressure-sensing guidewire including at least one pressure sensor configured to obtain a pressure measurement for use in determining the pressure gradient across the lesion. The catheter is configured to deliver or inject a non-pharmacological fluid, such as saline or blood, across the lesion in order to increase a flow rate there-through, thereby simulating hyperemia without the use of a pharmacological hyperemic agent. Once an increased flow rate that simulates hyperemia is achieved, the pressure sensor of the pressure-sensing guidewire may be utilized to measure the pressure gradient across the lesion in order to assess the severity of the lesion.

Abstract: A catheter is disclosed for providing a pressure measurement at a vascular lesion. The catheter includes a tubular component having dual lumens along at least a segment thereof in which a first lumen acts as a pressure inlet and a second lumen allows the catheter to be tracked over a guidewire. A plurality of openings are located along a distal segment of the tubular component that permit blood flow into the first lumen when disposed in vivo. A pressure sensor is located within a handle component of the catheter or within the tubular component to be in fluid communication with a proximal end of the first lumen. When the catheter is positioned at the vascular lesion, the first lumen fills with blood via the plurality of openings such that the pressure sensor is able to sense a pressure of the blood at a distal end of the catheter.

Abstract: A valve prosthesis and methods for implanting the prosthesis are provided. The prosthesis generally includes a self-expanding frame and two or more engagement arms. A valve prosthesis is sutured to the self-expanding frame. Each engagement arm corresponds to a native mitral valve leaflet. At least one engagement arm immobilizes the native leaflets, and holds the native leaflets close to the main frame. The prosthetic mitral valve frame also includes two or more anchor attachment points. Each anchor attachment point is attached to one or more anchors that help attach the valve prosthesis to the heart.

Abstract: Medical devices and methods for closing an anatomical aperture in a tissue are disclosed. The medical devices can include distal and proximal support structures, which can include a plurality of anchor members. A connection element can connect the distal and proximal support structures, and be configured to twist to create a seal within the medical device. In certain embodiments, a sheath about the medical device can be retracted to expose the distal support structure, which can allow it to revert to an anchoring configuration from a delivery configuration, such that the anchor members can engage an interior surface of the tissue. After twisting the connection element to form a seal, the sheath can be further retracted to expose the proximal support structure, which can allow it to revert to an anchoring configuration from a delivery configuration, such that the anchor members can engage an exterior surface of the tissue.

Abstract: A device useful for implantation at a native heart valve can include an anchor element having a tubular configuration defining a longitudinal direction and a circumference, a heart valve prosthesis disposed within the anchor element, and a plurality of elongate members positioned at equidistant angular intervals about the circumference of the anchor element. The device can be configured to be transitioned from a radially collapsed delivery configuration to a radially expanded implantation configuration, and the plurality of elongate members can have a length extending in the longitudinal direction of the tubular member in the expanded implantation configuration.

Abstract: A device useful for implantation at a native heart valve can include an anchor element having a tubular configuration defining a longitudinal direction and a circumference, a heart valve prosthesis disposed within the anchor element, and a plurality of elongate members positioned at equidistant angular intervals about the circumference of the anchor element. The device can be configured to be transitioned from a radially collapsed delivery configuration to a radially expanded implantation configuration, and the plurality of elongate members can have a length extending in the longitudinal direction of the tubular member in the expanded implantation configuration.

Abstract: A delivery system for deploying a medical device includes a first attachment member configured to selectively couple to and radially constrain a first end portion of the medical device. The delivery system also includes a second attachment member configured to selectively couple to and radially constrain a second end portion of the medical device. The first attachment member is configured to move relative to the second attachment member such that the first attachment member applies a first tensile force to the first end portion of a medical device in a first direction and the second attachment member applies a second tensile force to the second end portion of a medical device in a second direction substantially opposite from the first direction.

Abstract: A transcatheter valve prosthesis is disclosed that has a compressed, delivery configuration and an expanded configuration for deployment within a native heart valve. The valve prosthesis includes a self-expanding frame and a prosthetic valve component. The self-expanding frame includes a valve receiving portion defining an opening therethrough and first and second anchors at opposing ends of the valve receiving portion. The valve receiving portion is substantially planar and the first and second anchors are oriented substantially perpendicular to the valve receiving portion when the valve prosthesis is in the expanded configuration. The prosthetic valve component is disposed within the opening of the valve receiving portion and secured thereto.

Abstract: A dual valve prosthesis having first and second prosthetic valve sections is disclosed. The first prosthetic valve section includes a stent structure with a first prosthetic valve secured therein and the second prosthetic valve section includes an annular frame with a second prosthetic valve secured therein. When the dual valve prosthesis is in an expanded configuration, the annular frame extends from the stent structure such that the first and second prosthetic valves are laterally offset from each other. In a method in accordance herewith, the first and second prosthetic valve sections include prosthetic aortic and mitral valves, respectively, and the dual heart valve prosthesis is configured to replace both the native aortic and mitral valves of the heart in a single transcatheter heart valve implantation procedure.

Abstract: Medical device delivery assemblies are disclosed. The assembly may include a catheter-based delivery system. The assembly may include a pacing element to pace a patient's heart before, during, or after a procedure. The pacing element may be a detachable, implanting pacing element. The pacing element may be an implantable pacemaker and the implantable pacemaker may be disposed on a catheter-based delivery system. The assembly may include a prosthetic heart valve with one or more pacing elements on it. The pacing element may include a pacing strip or strips. These strips may be conductive or insulative. These strips may prevent, treat, or correct abnormal electrical communication in a heart.

Abstract: Devices, systems, and methods for crimping a medical device are disclosed. More specifically, the present disclosure relates to devices, systems, and methods for reducing the diameter of a collapsible heart valve prosthesis to be loaded onto a delivery device. The devices, systems, and methods using at least one funnel to crimp the heart valve prosthesis and load it onto the delivery system.

Abstract: Devices and methods for preparing a transcatheter heart valve system. The device includes a housing, sealing apparatuses and a port. The housing forms a chamber sized to receive a prosthetic valve and a portion of a delivery device. During use, the prosthesis is seated in the chamber, and the sealing apparatuses operated to seal the chamber about the delivery device. Air bubbles in a liquid delivered through the delivery device and to the chamber are removed from the system via the port, thereby flushing the system. Further, the device is manipulated to permit loading of the prosthesis into the delivery device in an air bubble-free environment.

Abstract: The delivery systems disclosed herein can create simultaneous movement of an inner and an outer sheath of the delivery system. The delivery systems can generally include a handle assembly and a delivery catheter. In certain embodiments, the inner shaft and the outer sheath can be slidably controlled by a control element in the handle. The handle assembly can include a housing with a thumbwheel acting as the control element. In certain embodiments, movement of the inner shaft and the outer sheath can be caused via a gear-type system. In certain embodiments, the handle assembly can include a rotatable housing. A control element can rotate the housing, which can cause a first boss associated with the outer sheath and a second boss associated with the inner shaft to move in opposite directions.

Abstract: A valve prosthesis and methods for implanting the prosthesis are provided. The prosthesis generally includes a self-expanding frame and two or more engagement arms. A valve prosthesis is sutured to the self-expanding frame. Each engagement arm corresponds to a native mitral valve leaflet. At least one engagement arm immobilizes the native leaflets, and holds the native leaflets close to the main frame. The prosthetic mitral valve frame also includes two or more anchor attachment points. Each anchor attachment point is attached to one or more anchors that help attach the valve prosthesis to the heart.