Abstract: Devices and methods for the treatment of heart conditions, and other medical purposes, include cardiac pacing systems. For example, this document describes temporary transvenous endocardial pacemaker systems and devices for deploying such systems without the need for conventional imaging procedures.

Abstract: A direct visualization catheter includes an elongate shaft defining a lumen and having a distal end portion and a proximal end portion and a transparent balloon attached to the distal end portion of the shaft. The balloon includes a first layer comprising a thermoset polymer and a plurality of polymeric fibers at least partially embedded in the thermoset polymer and a second layer disposed on the first layer and comprising a hydrogel.

Abstract: A heart valve anchor has a body that includes a distal portion, a distal end, a proximal portion, and a proximal end. The distal end and the proximal end define a longitudinal axis. The body has an expandable portion that includes a first radially expandable portion at the distal portion of the body, a second radially expandable portion at the proximal portion of the body, and a root portion disposed between the first and second radially expandable portions. The body has a first configuration adapted to be housed at least partially within a tissue penetrating device, and a second configuration in which the first and second radially expandable portions are partially or fully expanded such that the anchor engages tissue in a region between the first and second radially expandable portions.

Abstract: An introducer catheter device comprising a handle and an elongate shaft coupled to the handle and extending therefrom. The shaft defines a lumen therethrough, a longitudinal axis, and a first aperture in connection with the lumen. The shaft includes a movable deployment element configured for deploying an ancillary device from the first aperture at an angle relative to the longitudinal axis.

Abstract: Devices described herein can be used to directly measure left atrial pressure. For example, this document describes multiple embodiments of catheter-based, trans-esophageal tonometry devices that are used to directly measure left atrial pressure in a non-invasive manner.

Abstract: Devices and methods for the treatment of heart conditions, and other medical purposes, include cardiac pacing systems. For example, this document describes temporary transvenous endocardial pacemaker systems and devices for deploying such systems without the need for conventional imaging procedures.

Abstract: Devices and methods for the treatment of heart conditions are provided herein. For example, this document provides devices and methods for treating tricuspid valve regurgitation by percutaneously implanting a prosthetic tricuspid valve.

Abstract: A direct visualization catheter includes an elongate shaft defining a lumen and having a distal end portion and a proximal end portion and a transparent balloon attached to the distal end portion of the shaft. The balloon includes a first layer comprising a thermoset polymer and a plurality of polymeric fibers at least partially embedded in the thermoset polymer and a second layer disposed on the first layer and comprising a hydrogel.

Abstract: A direct visualization catheter includes an elongate shaft defining a lumen and having a distal end portion and a proximal end portion and a transparent balloon attached to the distal end portion of the shaft. The balloon includes a first layer comprising a thermoset polymer and a plurality of polymeric fibers at least partially embedded in the thermoset polymer and a second layer disposed on the first layer and comprising a hydrogel.

Abstract: A heart valve anchor has a body that includes a distal portion, a distal end, a proximal portion, and a proximal end. The distal end and the proximal end define a longitudinal axis. The body has an expandable portion that includes a first radially expandable portion at the distal portion of the body, a second radially expandable portion at the proximal portion of the body, and a root portion disposed between the first and second radially expandable portions. The body has a first configuration adapted to be housed at least partially within a tissue penetrating device, and a second configuration in which the first and second radially expandable portions are partially or fully expanded such that the anchor engages tissue in a region between the first and second radially expandable portions.

Abstract: A direct visualization catheter includes an elongate shaft defining a lumen and having a distal end portion and a proximal end portion and a transparent balloon attached to the distal end portion of the shaft. The balloon includes a first layer comprising a thermoset polymer and a plurality of polymeric fibers at least partially embedded in the thermoset polymer and a second layer disposed on the first layer and comprising a hydrogel.

Abstract: An introducer catheter device comprising a handle and an elongate shaft coupled to the handle and extending therefrom. The shaft defines a lumen therethrough, a longitudinal axis, and a first aperture in connection with the lumen. The shaft includes a movable deployment element configured for deploying an ancillary device from the first aperture at an angle relative to the longitudinal axis.

Abstract: A direct visualization catheter includes an elongate shaft defining a lumen and having a distal end portion and a proximal end portion and a transparent balloon attached to the distal end portion of the shaft. The balloon includes a first layer comprising a thermoset polymer and a plurality of polymeric fibers at least partially embedded in the thermoset polymer and a second layer disposed on the first layer and comprising a hydrogel.

Abstract: A direct visualization catheter includes an elongate shaft defining a lumen and having a distal end portion and a proximal end portion and a transparent balloon attached to the distal end portion of the shaft. The balloon includes a first layer comprising a thermoset polymer and a plurality of polymeric fibers at least partially embedded in the thermoset polymer and a second layer disposed on the first layer and comprising a hydrogel.

Abstract: Devices and methods for the treatment of heart conditions are provided herein. For example, this document provides devices and methods for treating tricuspid valve regurgitation by percutaneously implanting a prosthetic tricuspid valve.

Abstract: This document provides devices and methods for interventional treatment of heart conditions. For example, this document provides devices and methods that enhance intra-cardiac echocardiography visualization of interventional devices such as trans-septal puncturing needles.

Abstract: Devices provided herein can include implantable transseptal flow control components adapted to be implanted in an opening in a septal wall. In a closed configuration, the implantable transseptal flow control components provided herein prevent blood from flowing through the opening. In an open configuration, the implantable transseptal flow control components provided herein allow blood to flow from the left atrium to the right atrium. In a closed configuration, implantable transseptal flow control components provided herein can be configured such that blood does not stagnate at a location proximate to a left atrium flow control component side when the pressure differential is below a second predetermined threshold pressure value. Implantable transseptal flow control components provided herein can remain in a closed configuration when a pressure differential between the left atrium and the right atrium is less than a first non-zero predetermined threshold pressure value.

Abstract: A balloon catheter visualization system for repairing a heart valve in a patent includes one or more elongate shafts, each shaft defining at least one lumen and comprising a distal end portion and a proximal end portion. The system also includes a transparent balloon member coupled to the one or more elongate shafts and is in fluid communication with at least one lumen of the one or more elongate shafts. The system also includes an imaging element disposed within the balloon member and coupled to a distal end portion of the one or more elongate shafts, a fastener releasably coupled to a distal end portion of the one or more elongate shafts, and a connector coupled to a distal end portion of the one or more elongate shafts. The connector is adapted to fasten the fastener to tissue.

Abstract: A direct visualization catheter includes an elongate shaft defining a lumen and having a distal end portion and a proximal end portion and a transparent balloon attached to the distal end portion of the shaft. The balloon includes a first layer comprising a thermoset polymer and a plurality of polymeric fibers at least partially embedded in the thermoset polymer and a second layer disposed on the first layer and comprising a hydrogel.

Abstract: Devices and methods for the treatment of heart conditions. For example, a prosthetic heart valve and a transcatheter heart valve replacement method. The prosthetic heart valve can be configured into a low-profile configuration for containment within a small diameter delivery sheath.