Abstract: A delivery system for delivering an implantable device can include a delivery catheter, a sleeve, and a guide catheter. The delivery catheter can have a tubular body having a proximal end and a distal end, such that the distal end of the delivery catheter is configured to couple to the implantable device. The sleeve can define a lumen configured to receive the delivery catheter and the implantable device coupled thereto. A first fluid delivery port can be positioned on the delivery catheter or the sleeve. A mechanical seal can be coupled to the sleeve and configured to form a liquid-tight seal with the delivery catheter. A guide catheter can have a tubular body having a proximal end, a distal end, and a second fluid delivery port positioned thereon, wherein the proximal end of the guide catheter is configured to be connected to a distal end of the sleeve.

Abstract: Described herein are implant loading and delivery systems for treating heart failure. An implant loading system may include a funnel having a flared first end and a second end, such that the flared first end is configured for receiving and collapsing the expandable implant, and a sleeve removably coupled to the second end of the funnel and configured to transfer the expandable implant to a guide catheter. The expandable device may have a foot for contacting a first interior wall portion of a heart, a support frame including a plurality of radially expandable struts, and a membrane coupled to the support frame. The expandable device may be coupled to a delivery catheter. An expansion member coupled to a distal end of the delivery catheter may apply pressure to the support frame of the expandable device to move the expandable device from a collapsed configuration to an expanded deployed configuration.

Abstract: A system for improving cardiac function is provided. A foldable and expandable frame having at least one anchoring formation is attached to an elongate manipulator and placed in a catheter tube while folded. The tube is inserted into a left ventricle of a heart where the frame is ejected from the tube and expands in the left ventricle. Movements of the elongate manipulator cause the anchor to penetrate the heart muscle and the elongate manipulator to release the frame. The installed frame minimizes the effects of an akinetic portion of the heart forming an aneurysmic bulge. Devices and methods are described herein which are directed to the treatment of a patient's heart having, or one which is susceptible to heart failure, to improve diastolic function.

Abstract: Described herein are methods of treating a patient to prevent or correct cardiac remodeling following myocardial infarction. In general these methods may include inserting or implanting a device in a heart chamber to support the affected region within 72 hours after myocardial infarction. The device may be a support device (e.g., a resilient frame) and/or a partitioning device.

Abstract: Devices and systems including implants (which may be removable) and methods of using them for reducing ventricular volume. The implants described herein are cardiac implants that may be inserted into a patient's heart, particularly the left ventricle. The implant may support the heart wall, or may be secured to the heart wall. The implants are typically ventricular partitioning device for partitioning the ventricle into productive and non-productive regions in order to reduce the ventricular volume.

Abstract: Described herein are systems and methods for securing a polymeric sheet to rib components of a frame structure, wherein the rib components are jointed at a hub to form an expandable and collapsible implant. In general, the method may include the steps of decreasing a diameter of the frame structure; placing the frame structure into an assembly fixture, wherein the assembly fixture is configured to hold the frame structure in a loaded configuration with a decreased diameter; placing a polymeric sheet into the assembly fixture; and heating the assembly under pressure to fuse the sheet to the frame structure. In general, a fixture may include a first and second platen having a shaping portion and a rim portion positioned around the periphery of the platen, wherein the shaping portions are configured to hold the rib components of the frame structure in a loaded configuration with a decreased diameter.

Abstract: Described herein are devices, systems and methods for delivering an endocardial device. The systems for delivering the device transvascularly may generally include an elongate guide catheter having a proximal end and a distal end; a conical dilator at the distal end of the elongate guide catheter, the conical dilator being removable to enable delivery of the ventricular portioning device; a delivery catheter having a proximal and distal end; an expansion member near the distal end of the delivery catheter and configured to expand a plurality of struts of the partitioning device; and a coupling element configured to deployably secure to a hub of the partitioning device. The systems for delivering the device transapically may generally include an elongate access sheath; an elongate delivery catheter; an expansion member; and a coupling element proximal to the expansion member and configured to deployably secure to a hub of the partitioning device.

Abstract: Systems for partitioning a ventricle of a heart include a partitioning device or implant, and an applicator for inserting, repositioning and/or removing the partitioning device. The implant may support the ventricle wall and may reduce the volume of the ventricle. The delivery system for delivering and deploying a partitioning device into a ventricle may include a catheter having a distal coupling element for coupling to a partitioning device in a collapsed configuration; the catheter may also have an expansion member for applying force to the partitioning device to fully expand it into a deployed configuration and to secure or seal it against the ventricle wall.

Abstract: Devices and systems including implants (which may be removable) and methods of using them for reducing ventricular volume. The implants described herein are cardiac implants that may be inserted into a patient's heart, particularly the left ventricle. The implant may support the heart wall, or may be secured to the heart wall. The implants are typically ventricular partitioning device for partitioning the ventricle into productive and non-productive regions in order to reduce the ventricular volume.

Abstract: Removable cardiac implants, applicators for inserting, repositioning and/or removing them, and methods of using them are described. In particular, removable or repositionable ventricular partitioning devices are described. Systems including removable implants and applicators for inserting and/or removing them are also described.

Abstract: Described herein are methods of treating a patient to prevent or correct cardiac remodeling following myocardial infarction. In general these methods may include inserting or implanting a device in a heart chamber to support the affected region within 72 hours after myocardial infarction. The device may be a support device (e.g., a resilient frame) and/or a partitioning device.

Abstract: Devices and systems including implants (which may be removable) and methods of using them for reducing ventricular volume. The implants described herein are cardiac implants that may be inserted into a patient's heart, particularly the left ventricle. The implant may support the heart wall, or may be secured to the heart wall. The implants are typically ventricular partitioning device for partitioning the ventricle into productive and non-productive regions in order to reduce the ventricular volume.

Abstract: A system for improving cardiac function is provided. A foldable and expandable frame having at least one anchoring formation is attached to an elongate manipulator and placed in a catheter tube while folded. The tube is inserted into a left ventricle of a heart where the frame is ejected from the tube and expands in the left ventricle. Movements of the elongate manipulator cause the anchor to penetrate the heart muscle and the elongate manipulator to release the frame. The installed frame minimizes the effects of an akinetic portion of the heart forming an aneurysmic bulge.

Abstract: Devices and methods are described herein which are directed to the treatment of a patient's heart having, or one which is susceptible to heart failure, to improve diastolic function.

Abstract: A system for improving cardiac function is provided. A foldable and expandable frame having at least one anchoring formation is attached to an elongate manipulator and placed in a catheter tube while folded. The tube is inserted into a left ventricle of a heart where the frame is ejected from the tube and expands in the left ventricle. Movements of the elongate manipulator cause the anchor to penetrate the heart muscle and the elongate manipulator to release the frame. The installed frame minimizes the effects of an akinetic portion of the heart forming an aneurysmic bulge.

Abstract: Described herein are methods of treating a patient to prevent or correct cardiac remodeling following myocardial infarction. In general these methods may include inserting or implanting a device in a heart chamber to support the affected region within 72 hours after myocardial infarction. The device may be a support device (e.g., a resilient frame) and/or a partitioning device.

Abstract: Removable cardiac implants, applicators for inserting, repositioning and/or removing them, and methods of using them are described. In particular, removable or repositionable ventricular partitioning devices are described. Systems including removable implants and applicators for inserting and/or removing them are also described.

Abstract: Removable cardiac implants, applicators for inserting, repositioning and/or removing them, and methods of using them are described. In particular, removable or repositionable ventricular partitioning devices are described. Systems including removable implants and applicators for inserting and/or removing them are also described.

Abstract: A partitioning device for separating a patient's heart chamber into a productive portion and a non-productive portion which is suitable for treating patients with heart disease, particularly congestive heart failure. The partitioning device has a reinforced membrane with outwardly biased members to help seal the periphery of the membrane against the wall of the patient's heart chamber. In one embodiment, the outwardly biased member is an expansive strand that extends between adjacent ribs of an expandable frame which reinforces the membrane. In another embodiment, the outwardly biased member is a hydrophilic body such as foam which swells upon contact with body fluid such as blood in the heart chamber. The reinforced membrane has a central hub with a distally extending support stem with a plurality of feet which extend radially from a centerline axis and preferably have ends that are aligned in a common plane.

Abstract: Partitioning devices that may be secured and sealed within a heart chamber for separating a patient's heart chamber into a productive portion and a non-productive portion are described herein. The partitioning devices described herein may include a reinforced membrane with outwardly biased members. The reinforced membrane may have a central hub with a distally extending support stem with a plurality of feet which extend radially from a centerline axis and preferably have ends that are aligned in a common plane. These devices may be secured within the heart chamber by sealing them to the wall of the heart chamber, for example, by inflating an inflatable element on the periphery of the device. The non-productive portion may be filled with a material, including occlusive materials. Sealing and/or filling the non-productive portion formed by the devices described herein may help prevent leakage from the non-productive region.