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: Interatrial shunts are described herein that are designed to benefit both the left side of the heart and the right side of the heart. The interatrial shunt is anchored in the atrial septum to permit blood to flow between atrial heart chambers across the atrial septum. In accordance with some aspects, the lumen of the shunt has an effective orifice area selected to permit blood flow across the atrial septum to unload the patient's left ventricle with beneficial effects on the patient's right ventricle. The shunts are structured to be suitably anchored at the atrial septum for long-term implantation. Further, the shunts preferably have insignificant late lumen loss. The interatrial shunts are expected to treat pathologies such as heart failure and pulmonary hypertension.

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 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: Devices are provided with a bridge made of a biocompatible material that surrounds a neck region of an encapsulated shunt. In one embodiment, the bridge is configured to maintain an outer diameter while the diameter of the neck region is reduced or increased in vivo to adjust the fluid flow rate through the device. The bridge may have an outer diameter that is configured to be placed within an enlarged septal hole. Methods for adjusting the flow of fluid and methods for the manufacture of such devices are also provided.

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: 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: 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, devices and methods described herein can be used to monitor and treat cardiovascular disease, and more specifically, can be used to determine heart rate (HR), determine respiration rate (RR) and classify cardiac rhythms based on atrial intracardiac electrogram (IEGM) and atrial pressure (AP) signals. The atrial IEGM and AP signals are subject to spectrum transforms to obtain an atrial IEGM frequency spectrum and an AP frequency spectrum. Based on peaks in the atrial IEGM and AP frequency spectrums measures of HR and RR are determined, and arrhythmias are detected and/or arrhythmia discrimination is performed.

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, devices and methods described herein can be used to monitor and treat cardiovascular disease, and more specifically, can be used to determine heart rate (HR), determine respiration rate (RR) and classify cardiac rhythms based on atrial intracardiac electrogram (IEGM) and atrial pressure (AP) signals. The atrial IEGM and AP signals are subject to spectrum transforms to obtain an atrial IEGM frequency spectrum and an AP frequency spectrum. Based on peaks in the atrial IEGM and AP frequency spectrums measures of HR and RR are determined, and arrhythmias are detected and/or arrhythmia discrimination is performed.

Abstract: Systems, devices and methods described herein can be used to monitor and treat cardiovascular disease, and more specifically, can be used to determine heart rate (HR), determine respiration rate (RR) and classify cardiac rhythms based on atrial intracardiac electrogram (IEGM) and atrial pressure (AP) signals. The atrial IEGM and AP signals are subject to spectrum transforms to obtain an atrial IEGM frequency spectrum and an AP frequency spectrum. Based on peaks in the atrial IEGM and AP frequency spectrums measures of HR and RR are determined, and arrhythmias are detected and/or arrhythmia discrimination is performed.

Abstract: This invention relates generally to systems and methods for optimizing the performance and minimizing complications related to implanted sensors, such as pressure sensors, for the purposes of detecting, diagnosing and treating cardiovascular disease in a medical patient. Systems and methods for anchoring implanted sensors to various body structures is also provided.

Abstract: A method of treating cardiovascular disease in a medical patient is provided. The method includes the steps of generating a sensor signal indicative of a fluid pressure within the left atrium of the patient's heart, and delivering an electrical stimulus to a location in the heart. The electrical stimulus is delivered based at least in part on the sensor signal. The method also includes the steps of generating a processor output indicative of a treatment to a signaling device. The processor output is based at least in part on the sensor signal. At least two treatment signals are provided to the medical patient. The treatment signals are distinguishable from one another by the patient, and are indicative of a therapeutic treatment. The treatment signals are based at least in part on the processor output.

Abstract: Systems, devices and methods described herein can be used to monitor and treat cardiovascular disease, and more specifically, can be used to determine heart rate (HR), determine respiration rate (RR) and classify cardiac rhythms based on atrial intracardiac electrogram (IEGM) and atrial pressure (AP) signals. The atrial IEGM and AP signals are subject to spectrum transforms to obtain an atrial IEGM frequency spectrum and an AP frequency spectrum. Based on peaks in the atrial IEGM and AP frequency spectrums measures of HR and RR are determined, and arrhythmias are detected and/or arrhythmia discrimination is performed.

Abstract: This invention relates generally to systems and methods for optimizing the performance and minimizing complications related to implanted sensors, such as pressure sensors, for the purposes of detecting, diagnosing and treating cardiovascular disease in a medical patient. Systems and methods for anchoring implanted sensors to various body structures is also provided.

Abstract: Systems, devices and methods described herein can be used to monitor and treat cardiovascular disease, and more specifically, can be used to determine heart rate (HR), determine respiration rate (RR) and classify cardiac rhythms based on atrial intracardiac electrogram (IEGM) and atrial pressure (AP) signals. The atrial IEGM and AP signals are subject to spectrum transforms to obtain an atrial IEGM frequency spectrum and an AP frequency spectrum. Based on peaks in the atrial IEGM and AP frequency spectrums measures of HR and RR are determined, and arrhythmias are detected and/or arrhythmia discrimination is performed.

Abstract: This invention relates generally to systems and methods for optimizing the performance and minimizing complications related to implanted sensors, such as pressure sensors, for the purposes of detecting, diagnosing and treating cardiovascular disease in a medical patient. Systems and methods for anchoring implanted sensors to various body structures is also provided.

Abstract: A method of treating cardiovascular disease in a medical patient is provided. The method includes the steps of generating a sensor signal indicative of a fluid pressure within the left atrium of the patient's heart, and delivering an electrical stimulus to a location in the heart. The electrical stimulus is delivered based at least in part on the sensor signal. The method also includes the steps of generating a processor output indicative of a treatment to a signaling device. The processor output is based at least in part on the sensor signal. At least two treatment signals are provided to the medical patient. The treatment signals are distinguishable from one another by the patient, and are indicative of a therapeutic treatment. The treatment signals are based at least in part on the processor output.

Abstract: The invention provides improved apparatus and methods for treating congestive heart failure in a medical patient. The apparatus includes a pressure transducer permanently implantable within the left atrium of the patient's heart and operable to generate electrical signals indicative of fluid pressures within the patient's left atrium. The pressure transducer is connected to a flexible electrical lead, which is connected in turn to electrical circuitry, which in the preferred embodiment includes digital circuitry for processing electrical signals. The electrical circuitry processes the electrical signals from the pressure transducer and, based at least in part on those signals, generates a signal that indicates a desired therapeutic treatment for treating the patient's condition. That signal is then communicated to the patient via a patient signaling device, following which the patient administers to him or herself the prescribed therapeutic treatment indicated by the signal.