Abstract: Various stabilizing systems and devices are described for holding and maneuvering medical devices. Some systems and devices include a channel and one or more clamps. The one or more clamps can include one or more of a foot and a movable retaining flange for securing the position of the clamp in the channel.

Abstract: A method for deploying an expandable prosthetic heart valve in a patient includes introducing a guidewire into a patient and advancing the guidewire through a vasculature of a patient to a deployment site. A distal end portion of a delivery apparatus and the prosthetic heart valve mounted in a radially compressed configuration on an expandable member of the distal end portion are advanced over the guidewire. The prosthetic heart valve is positioned at the deployment site. The expandable member is radially expanded, causing the prosthetic heart valve to radially expand to a radially expanded configuration. The prosthetic heart valve comprises an expandable metal frame and one or more leaflets attached to the frame, wherein the frame comprises a plurality of struts arranged to form two circumferentially extending rows of hexagonal shaped cells.

Abstract: A method for deploying an expandable prosthetic heart valve in a patient includes introducing a guidewire into a patient and advancing the guidewire through a vasculature of a patient to a deployment site. A distal end portion of a delivery apparatus and the prosthetic heart valve mounted in a radially compressed configuration along the distal end portion are advanced over the guidewire. The prosthetic heart valve is positioned at the deployment site. A screw mechanism is rotated, which exerts an axially directed onto the prosthetic heart valve, causing the prosthetic heart valve to radially expand from the radially compressed configuration to a radially expanded configuration.

Abstract: Delivery systems and methods of delivering devices or implants are disclosed. The devices or implants can be configured as valve repair devices or treatment devices have gripping members that are openable and closable to attach the device to leaflets of a native heart valve. The delivery systems are configured to position the device or implant and open and close the gripping members of the device or implant.

Abstract: Assemblies and delivery apparatus for delivering a medical device into a patient's vasculature are disclosed. In some examples, an assembly includes a delivery apparatus and a radially compressible and expandable prosthetic heart valve. The delivery apparatus includes a handle, a first shaft and a second shaft extending from the handle, and a locking mechanism to prevent axial movement of the second shaft relative to first shaft. The second shaft extends coaxially through the first shaft and includes, at a distal end portion thereof, a balloon, one or more radiopaque markers, and the prosthetic valve radially compressed over the balloon. A flared end piece extending from the first shaft covers a proximal portion of the balloon during advancing of the delivery apparatus through a patient's vasculature. The first shaft is retractable relative to the second shaft to expose the balloon from the flared end piece.

Abstract: Disclosed embodiments of introducer devices provide hemostatic sealing and allow a delivery catheter to be inserted through the introducer seals without the use of a separate loader device that covers a medical device that is mounted on the catheter. Some disclosed introducers comprise a housing, a distal sheath extending distally from the housing and adapted to be inserted into a patient's vasculature, a distal hemostatic seal mounted within the housing and a proximal hemostatic seal mounted within the housing, and a slidable tube positioned within the housing that is movable longitudinally relative to the distal hemostatic seal between a proximal position and a distal position, wherein in the proximal position a distal end of the tube is positioned proximal to the distal hemostatic seal with the distal hemostatic seal closed, and wherein in the distal position the distal end of the tube extends through the distal hemostatic seal.

Abstract: Disclosed embodiments of introducer devices provide hemostatic sealing and allow a delivery catheter to be inserted through the introducer seals without the use of a separate loader device that covers a medical device that is mounted on the catheter. Some disclosed introducers comprise a housing, a distal sheath extending distally from the housing and adapted to be inserted into a patient's vasculature, a distal hemostatic seal mounted within the housing and a proximal hemostatic seal mounted within the housing, and a slidable tube positioned within the housing that is movable longitudinally relative to the distal hemostatic seal between a proximal position and a distal position, wherein in the proximal position a distal end of the tube is positioned proximal to the distal hemostatic seal with the distal hemostatic seal closed, and wherein in the distal position the distal end of the tube extends through the distal hemostatic seal.

Abstract: Delivery apparatus and methods for delivering a medical device into a patient's vasculature are disclosed. In some examples, a method includes inserting, into a patient, a distal end portion of a delivery apparatus including a radially compressed prosthetic valve mounted around a balloon, advancing the distal end through the patient's vasculature, and inflating the balloon to radially expand the prosthetic valve at a native heart valve. The delivery apparatus includes a handle, a first shaft and a second shaft extending from the handle, and a locking mechanism to prevent axial movement of the second shaft relative to first shaft. The second shaft extends coaxially through the first shaft and includes the balloon, the radially compressed prosthetic valve, and one or more radiopaque markers at a distal end portion. The first shaft includes an end piece covering a proximal portion of the balloon during the advancing of the delivery apparatus.

Abstract: Pinch devices and access systems that can be used to secure a prosthetic heart valve to a heart valve annulus and to treat valvular insufficiency. A pinch device can be a separate expandable element from the prosthetic heart valve that is first advanced to the annulus and deployed, after which an expandable prosthetic heart valve can be advanced to within the annulus and deployed. The two elements can clamp/pinch the heart valve leaflets to hold the prosthetic heart valve in place. The pinch device can have a flexible, expandable annular frame. A combined delivery system can deliver the pinch device and prosthetic heart valve with just a single access point and aid more accurate coaxial deployment. The pinch device can be mounted near distal end of an access sheath, and a catheter for delivering the prosthetic heart valve can be passed through a lumen of the same access sheath.

Abstract: Components for valve treatment systems are disclosed. Valve treatment systems can include a delivery system for an implantable device. The delivery system can include one or more of clasp control components slidably disposed on a catheter handle, a control element for opening and closing the implantable device, a catheter assembly with features to reduce friction with another catheter assembly, grips for attaching catheter assemblies to clamps, catheter assemblies with features that stiffen or provide variable stiffness, and catheter assemblies with one or more steering control lumens incorporated into a reinforcement layer.

Abstract: Embodiments of the present disclosure provide an introducer device and methods for introducing a medical device into a patient's vasculature. In one embodiment, a method of using an introducer device including a housing, a hemostatic seal mounted within the housing, and a tube extending into the housing and movable longitudinally relative to the hemostatic seal between a proximal position and a distal position, includes moving the tube to the distal position such that the distal end of the tube extends through the hemostatic seal. The method further includes inserting a distal end portion of the medical device through the tube and into the patient's vasculature without contacting the hemostatic seal.

Abstract: A stabilizing base includes one or more legs and a platform attached to the one or more legs. One or more of a height of the platform relative to an operating table, a position of the platform along a width of the operating table, a position of the platform along a length of the operating table, and an angular position of the platform relative to the operating table can be adjusted.

Abstract: Pinch devices and access systems that can be used to secure a prosthetic heart valve to a heart valve annulus and to treat valvular insufficiency. A pinch device can be a separate expandable element from the prosthetic heart valve that is first advanced to the annulus and deployed, after which an expandable prosthetic heart valve can be advanced to within the annulus and deployed. The two elements can clamp/pinch the heart valve leaflets to hold the prosthetic heart valve in place. The pinch device can have a flexible, expandable annular frame. A combined delivery system can deliver the pinch device and prosthetic heart valve with just a single access point and aid more accurate coaxial deployment. The pinch device can be mounted near distal end of an access sheath, and a catheter for delivering the prosthetic heart valve can be passed through a lumen of the same access sheath.

Abstract: A method of delivery a prosthetic heart valve includes inserting a delivery apparatus and a prosthetic heart valve into a patient's vasculature. The delivery apparatus includes a steerable guide catheter, a balloon catheter, and a flex indicator. The balloon catheter extends coaxially through the guide catheter, the prosthetic heart valve is mounted on a distal end portion of the balloon catheter, and the flex indicator is movably coupled to a handle of the guide catheter. The method further includes adjusting flexion of a steerable section of the guide catheter to position the prosthetic heart valve. The flex indicator moves relative to the handle of the guide catheter as the flexion of the steerable section is adjusted, and the handle comprises one or more visual indicators adjacent the flex indicator to provide visual indication of an amount of flexion of the steerable section of the guide catheter.

Abstract: Assemblies and delivery apparatus for delivering a medical device into a patient's vasculature are disclosed. In some examples, an assembly includes a delivery apparatus and a radially compressible and expandable prosthetic heart valve. The delivery apparatus includes a handle, a first shaft and a second shaft extending from the handle, and a locking mechanism to prevent axial movement of the second shaft relative to first shaft. The second shaft extends coaxially through the first shaft and includes, at a distal end portion thereof, a balloon, one or more radiopaque markers, and the prosthetic valve radially compressed over the balloon. A flared end piece extending from the first shaft covers a proximal portion of the balloon during advancing of the delivery apparatus through a patient's vasculature. The first shaft is retractable relative to the second shaft to expose the balloon from the flared end piece.

Abstract: A method for replacing a stenotic native aortic valve of a patient can include inserting a delivery apparatus into a femoral artery of the patient, the delivery apparatus having a first shaft extending from the handle, a second shaft disposed around the first shaft, a third shaft extending through the second shaft, and a valve cover coupled to the first shaft. The valve cover can be in a first state housing an entirety of a prosthetic heart valve and retaining the prosthetic heart valve in a radially compressed state during the act of inserting. The method can further include advancing the delivery apparatus through the aorta of the patient to position the valve cover and the prosthetic heart valve within the native aortic valve, and moving the valve cover longitudinally from the first state to a second state in which the entirety of the prosthetic heart valve is uncovered.

Abstract: Various stabilizing systems and devices are described for holding and maneuvering medical devices. Some systems and devices include a channel and one or more clamps. The one or more clamps can include one or more of a foot and a movable retaining flange for securing the position of the clamp in the channel.

Abstract: A method for replacing a stenotic native aortic valve of a patient can include inserting a delivery apparatus into a femoral artery of the patient, the delivery apparatus having a first shaft extending from the handle, a second shaft disposed around the first shaft, a third shaft extending through the second shaft, and a valve cover coupled to the first shaft. The valve cover can be in a first state housing an entirety of a prosthetic heart valve and retaining the prosthetic heart valve in a radially compressed state during the act of inserting. The method can further include advancing the delivery apparatus through the aorta of the patient to position the valve cover and the prosthetic heart valve within the native aortic valve, and moving the valve cover longitudinally from the first state to a second state in which the entirety of the prosthetic heart valve is uncovered.