Abstract: Interatrial shunts having incorporated physiologic sensors are provided for monitoring and treating cardiovascular syndromes, including heart failure and pulmonary hypertension, in which the one or more sensors are affixed to the shunt to measure a physiologic parameter within the interatrial shunt. The shunt may include an anchor having a first flared region, a second flared region, and a neck region disposed between the first flared region and the second flared region, and a biocompatible covering disposed on the anchor to form a lumen. The one or more sensors may be pivotally coupled to the first flared region such that the one or more sensors may transition between a delivery configuration and a deployed configuration where the sensing surface of the one or more sensors is in fluid communication with the lumen.

Abstract: Interatrial shunts having incorporated physiologic sensors are provided for monitoring and treating cardiovascular syndromes, including heart failure and pulmonary hypertension, in which the one or more sensors are affixed to the shunt to measure a physiologic parameter within the interatrial shunt. The one or more sensors may be directly affixed to or within a lumenal surface of the shunt or may be disposed on a support structure in a spaced relation to the shunt lumen, the one or more sensors disposed at locations subject to little or no pannus formation or cardiac wall motion artifact.

Abstract: Systems and methods for the manufacture of an hourglass shaped stent-graft assembly having an hourglass shaped stent, graft layers, and an assembly mandrel having an hourglass shaped mandrel portion. Hourglass shaped stent may have superelastic and self-expanding properties. Hourglass shaped stent may be encapsulated using hourglass shaped mandrel assembly coupled to a dilation mandrel used for depositing graft layers upon hourglass shaped mandrel assembly. Hourglass shaped mandrel assembly may have removably coupled conical portions. The stent-graft assembly may be compressed and heated to form a monolithic layer of biocompatible material. Encapsulated hourglass shaped stents may be used to treat subjects suffering from heart failure by implanting the encapsulated stent securely in the atrial septum to allow blood flow from the left atrium to the right atrium when blood pressure in the left atrium exceeds that on the right atrium. The encapsulated stents may also be used to treat pulmonary hypertension.

Abstract: An asymmetric device for regulating blood volume distribution across a patient's atrial septum having a first expandable end region and a second expandable end region. The first expandable end region is transitionable from a contracted delivery state to an expanded deployed state in which the first expandable end region extends into the patient's left atrium and an inlet end of the first expandable end region is in a first plane. The second expandable end region is transitionable from a contracted delivery state to an expanded deployed state in which the second expandable end region extends into the patient's right atrium and an outlet end of the second expandable end region is in a second plane, such that the first plane intersects the second plane. The device further includes a neck region joining the first expandable end region to the second expandable end region, wherein the neck region is sized and shaped for placement in the patient's atrial septum.

Abstract: Interatrial shunts having incorporated physiologic sensors are provided for monitoring and treating cardiovascular syndromes, including heart failure and pulmonary hypertension, in which the one or more sensors are affixed to the shunt to measure a physiologic parameter within the interatrial shunt. The one or more sensors may be directly affixed to or within a lumenal surface of the shunt or may be disposed on a support structure in a spaced relation to the shunt lumen, the one or more sensors disposed at locations subject to little or no pannus formation or cardiac wall motion artifact.

Abstract: Systems and methods for the manufacture of an hourglass shaped stent-graft assembly comprising an hourglass shaped stent, graft layers, and an assembly mandrel having an hourglass shaped mandrel portion. Hourglass shaped stent may have superelastic and self-expanding properties. Hourglass shaped stent may be encapsulated using hourglass shaped mandrel assembly coupled to a dilatation mandrel used for depositing graft layers upon hourglass shaped mandrel assembly. Hourglass shaped mandrel assembly may have removably coupled conical portions. The stent-graft assembly may be compressed and heated to form a monolithic layer of biocompatible material. Encapsulated hourglass shaped stents may be used to treat subjects suffering from heart failure by implanting the encapsulated stent securely in the atrial septum to allow blood flow from the left atrium to the right atrium when blood pressure in the left atrium exceeds that on the right atrium.

Abstract: Devices are provided with an internal dimension that can be reduced and increased in vivo. In one example, an interatrial shunt for placement at an atrial septum of a patient's heart includes a body. The body includes first and second regions coupled in fluid communication by a neck region. The body includes a shape-memory material. The body defines a passageway through the neck region for blood to flow between a first atrium and a second atrium. The first and second regions are superelastic at body temperature, and the neck region is malleable at body temperature. A flow area of the passageway through the neck region may be adjusted in vivo.

Abstract: Systems and methods for the manufacture of an hourglass shaped stent-graft assembly comprising an hourglass shaped stent, graft layers, and an assembly mandrel having an hourglass shaped mandrel portion. Hourglass shaped stent may have superelastic and self-expanding properties. Hourglass shaped stent may be encapsulated using hourglass shaped mandrel assembly coupled to a dilatation mandrel used for depositing graft layers upon hourglass shaped mandrel assembly. Hourglass shaped mandrel assembly may have removably coupled conical portions. The stent-graft assembly may be compressed and heated to form a monolithic layer of biocompatible material. Encapsulated hourglass shaped stents may be used to treat subjects suffering from heart failure by implanting the encapsulated stent securely in the atrial septum to allow blood flow from the left atrium to the right atrium when blood pressure in the left atrium exceeds that on the right atrium.

Abstract: Systems and methods for implanting a shunt for regulating blood pressure between a patient's left and right atria are provided. The shunt comprises an anchor having a neck region, first and second end regions, and a conduit affixed with the anchor formed of a biocompatible material that is resistant to transmural and translation tissue ingrowth and that reduces a risk of paradoxical embolism. The shunt may be advanced through the sheath until the first region protrudes from the sheath and self-expands within the left atrium. The shunt and the sheath may then be retracted until the first region contacts the left side of the atrial septum. The sheath may further be retracted until the counterforce exerted by shunt tension on the atrial septum overcomes the friction of the retained portions of the shunt such that the second region is exposed from the sheath and self-expands within the second atrium.

Abstract: A device for providing a passage between a first and second heart chamber is provided. The device includes a middle region having first and second ends, a lumen extending therethrough having a longitudinal axis, a first end region coupled to the first end, and a second end region coupled to the second end. The first end region may be delivered in the first heart chamber in a compressed state and transitioned to a deployed state, the first end region being deformable such that portions of the first end region are expandable to different angles relative to the longitudinal axis. The second end region may be delivered in the second heart chamber in a compressed state and transitioned to a deployed state therein, the second end region being deformable such that portions of the second end region are expandable to different angles relative to the longitudinal axis.

Abstract: Systems and methods for the manufacture of an hourglass shaped stent-graft assembly having an hourglass shaped stent, graft layers, and an assembly mandrel having an hourglass shaped mandrel portion. Hourglass shaped stent may have superelastic and self-expanding properties. Hourglass shaped stent may be encapsulated using hourglass shaped mandrel assembly coupled to a dilation mandrel used for depositing graft layers upon hourglass shaped mandrel assembly. Hourglass shaped mandrel assembly may have removably coupled conical portions. The stent-graft assembly may be compressed and heated to form a monolithic layer of biocompatible material. Encapsulated hourglass shaped stents may be used to treat subjects suffering from heart failure by implanting the encapsulated stent securely in the atrial septum to allow blood flow from the left atrium to the right atrium when blood pressure in the left atrium exceeds that on the right atrium. The encapsulated stents may also be used to treat pulmonary hypertension.

Abstract: A shunt for regulating blood pressure between a patient's left atrium and right atrium comprises an anchor comprising a neck region, first and second end regions, and a conduit affixed with the anchor that formed of a biocompatible material that is resistant to transmural and translation tissue ingrowth and that reduces a risk of paradoxical embolism.

Abstract: Devices are provided with an internal dimension that can be reduced and increased in vivo. In one example, an interatrial shunt for placement at an atrial septum of a patient's heart includes a body. The body includes first and second regions coupled in fluid communication by a neck region. The body includes a shape-memory material. The body defines a passageway through the neck region for blood to flow between a first atrium and a second atrium. The first and second regions are superelastic at body temperature, and the neck region is malleable at body temperature. A flow area of the passageway through the neck region may be adjusted in vivo.

Abstract: A shunt for regulating blood pressure between a patient's left atrium and right atrium comprises an anchor comprising a neck region, first and second end regions, and a conduit affixed with the anchor that formed of a biocompatible material that is resistant to transmural and translation tissue ingrowth and that reduces a risk of paradoxical embolism.

Abstract: A device for precise control of blood flow across an interatrial septum is provided. The device includes a sheath having a first set of openings disposed within a first atrium while a second set of openings is disposed within a second atrium. An actuator may be actuated to move an inner sleeve within the sheath to modify the area of second set of openings to permit blood to flow between the first and second atria responsive to a pressure gradient across the interatrial septum via the first and second openings at a blood flow rate corresponding with the area of the second set of openings of the sheath. In addition, the patient's hemodynamics responsive to the shunting of blood across the interatrial septum at each incremental area of the opening may be monitored for selecting a specific sized implantable interatrial shunt for the patient.

Abstract: Systems and methods for the manufacture of an hourglass shaped stent-graft assembly comprising an hourglass shaped stent, graft layers, and an assembly mandrel having an hourglass shaped mandrel portion. Hourglass shaped stent may have superelastic and self-expanding properties. Hourglass shaped stent may be encapsulated using hourglass shaped mandrel assembly coupled to a dilation mandrel used for depositing graft layers upon hourglass shaped mandrel assembly. Hourglass shaped mandrel assembly may have removably coupled conical portions. The stent-graft assembly may be compressed and heated to form a monolithic layer of biocompatible material. Encapsulated hourglass shaped stents may be used to treat subjects suffering from heart failure by implanting the encapsulated stent securely in the atrial septum to allow blood flow from the left atrium to the right atrium when blood pressure in the left atrium exceeds that on the right atrium. The encapsulated stents may also be used to treat pulmonary hypertension.

Abstract: Systems and methods for delivering a device for regulating blood pressure between a patient's left atrium and right atrium are provided. The delivery apparatus may include a first catheter, a hub distal to the first catheter, the hub having one or more engagers disposed thereon, the one or more engagers configured to releasably engage with a first expandable end of the shunt in a contracted delivery state within a lumen of a sheath, and an second catheter extending through a center lumen of the first catheter and the hub, wherein the first catheter, the hub, and the second catheter are independently moveable relative to the sheath. The inventive devices may reduce left atrial pressure and left ventricular end diastolic pressure, and may increase cardiac output, increase ejection fraction, relieve pulmonary congestion, and lower pulmonary artery pressure, among other benefits.

Abstract: Systems and methods for the manufacture of an hourglass shaped stent-graft assembly comprising an hourglass shaped stent, graft layers, and an assembly mandrel having an hourglass shaped mandrel portion. Hourglass shaped stent may have superelastic and self-expanding properties. Hourglass shaped stent may be encapsulated using hourglass shaped mandrel assembly coupled to a dilatation mandrel used for depositing graft layers upon hourglass shaped mandrel assembly. Hourglass shaped mandrel assembly may have removably coupled conical portions. The stent-graft assembly may be compressed and heated to form a monolithic layer of biocompatible material. Encapsulated hourglass shaped stents may be used to treat subjects suffering from heart failure by implanting the encapsulated stent securely in the atrial septum to allow blood flow from the left atrium to the right atrium when blood pressure in the left atrium exceeds that on the right atrium.

Abstract: An asymmetric device for regulating blood volume distribution across a patient's atrial septum having a first expandable end region and a second expandable end region. The first expandable end region is transitionable from a contracted delivery state to an expanded deployed state in which the first expandable end region extends into the patient's left atrium and an inlet end of the first expandable end region is in a first plane. The second expandable end region is transitionable from a contracted delivery state to an expanded deployed state in which the second expandable end region extends into the patient's right atrium and an outlet end of the second expandable end region is in a second plane, such that the first plane intersects the second plane. The device further includes a neck region joining the first expandable end region to the second expandable end region, wherein the neck region is sized and shaped for placement in the patient's atrial septum.

Abstract: Systems and methods for the manufacture of an hourglass shaped stent-graft assembly comprising an hourglass shaped stent, graft layers, and an assembly mandrel having an hourglass shaped mandrel portion. Hourglass shaped stent may have superelastic and self-expanding properties. Hourglass shaped stent may be encapsulated using hourglass shaped mandrel assembly coupled to a dilation mandrel used for depositing graft layers upon hourglass shaped mandrel assembly. Hourglass shaped mandrel assembly may have removably coupled conical portions. The stent-graft assembly may be compressed and heated to form a monolithic layer of biocompatible material. Encapsulated hourglass shaped stents may be used to treat subjects suffering from heart failure by implanting the encapsulated stent securely in the atrial septum to allow blood flow from the left atrium to the right atrium when blood pressure in the left atrium exceeds that on the right atrium. The encapsulated stents may also be used to treat pulmonary hypertension.