Abstract: A method of delivering a transcutaneous dual valve replacement (TDVR) device to a patient includes the steps of advancing a guide catheter into the heart of the patient, advancing a support wire through the guide catheter and across the mitral valve of the heart of the patient, removing the guide catheter, advancing a delivery sheath over the support wire and across both the aortic valve and the mitral valve of the heart of the patient, advancing the TDVR device over the support wire and through the delivery sheath, removing the delivery sheath, expanding a first segment of the TDVR device in the mitral valve and a second segment of the TDVR device in the aortic valve, and removing the support wire.

Abstract: A device for correcting a compression-type fracture including a housing at a proximal end of the device, a cannula extending from the housing and through a directional balloon, and a tip at a distal end of the cannula, wherein the cannula has an outer tube for supplying fluid to the balloon and an inner tube positioned within the outer tube for supplying cement through at least one opening in the distal end of the cannula. A method of using the device where the device is inserted into a fracture site, the balloon is inflated to elevate fragments of the fracture, cement is injected into the opening created by elevating the fragments of the fracture and the device is removed from the fracture site. The balloon may be deflated before the injection of the cement or simultaneous with the injection of the cement.

Abstract: A device for correcting a compression-type fracture including a housing at a proximal end of the device, a cannula extending from the housing and through a directional balloon, and a tip at a distal end of the cannula, wherein the cannula has an outer tube for supplying fluid to the balloon and an inner tube positioned within the outer tube for supplying cement through at least one opening in the distal end of the cannula. A method of using the device where the device is inserted into a fracture site, the balloon is inflated to elevate fragments of the fracture, cement is injected into the opening created by elevating the fragments of the fracture and the device is removed from the fracture site. The balloon may be deflated before the injection of the cement or simultaneous with the injection of the cement.

Abstract: A device for correcting a compression-type fracture including a housing at a proximal end of the device, a cannula extending from the housing and through a directional balloon, and a tip at a distal end of the cannula, wherein the cannula has an outer tube for supplying fluid to the balloon and an inner tube positioned within the outer tube for supplying cement through at least one opening in the distal end of the cannula. A method of using the device where the device is inserted into a fracture site, the balloon is inflated to elevate fragments of the fracture, cement is injected into the opening created by elevating the fragments of the fracture and the device is removed from the fracture site. The balloon may be deflated before the injection of the cement or simultaneous with the injection of the cement.

Abstract: A method of delivering a transcutaneous dual valve replacement (TDVR) device to a patient includes the steps of advancing a guide catheter into the heart of the patient, advancing a support wire through the guide catheter and across the mitral valve of the heart of the patient, removing the guide catheter, advancing a delivery sheath over the support wire and across both the aortic valve and the mitral valve of the heart of the patient, advancing the TDVR device over the support wire and through the delivery sheath, removing the delivery sheath, expanding a first segment of the TDVR device in the mitral valve and a second segment of the TDVR device in the aortic valve, and removing the support wire.

Abstract: A device for correcting a compression-type fracture including a housing at a proximal end of the device, a cannula extending from the housing and through a directional balloon, and a tip at a distal end of the cannula, wherein the cannula has an outer tube for supplying fluid to the balloon and an inner tube positioned within the outer tube for supplying cement through at least one opening in the distal end of the cannula. A method of using the device where the device is inserted into a fracture site, the balloon is inflated to elevate fragments of the fracture, cement is injected into the opening created by elevating the fragments of the fracture and the device is removed from the fracture site. The balloon may be deflated before the injection of the cement or simultaneous with the injection of the cement.

Abstract: The present invention provides devices and methods for closing a physical anomaly comprising two overlapping layers of tissue, such as a patent foramen ovale (“PFO”). A PFO is comprised of two overlapping layers of malformed interatrial septa, the septum primum and the septum secundum, that form a tunnel between the right atrium and the left atrium. The closure device includes two wings connected to a central arm. The device is delivered through the PFO tunnel in a substantially linear configuration such that the central arm is seated within the PFO tunnel, the first wing extends into the right atrium, and the second wing extends into the left atrium. Once implanted, the closure device is reconfigured such that the arm is seated within the PFO tunnel, the first wing folds against the septum secundum, and the second wing folds against the septum primum, thereby sealing the defect.

Abstract: The present invention provides devices and methods for closing a physical anomaly comprising two overlapping layers of tissue, such as a patent foramen ovale (“PFO”). A PFO is comprised of two overlapping layers of malformed interatrial septa, the septum primum and the septum secundum, that form a tunnel between the right atrium and the left atrium. The closure device includes two wings connected to a central arm. The device is delivered through the PFO tunnel in a substantially linear configuration such that the central arm is seated within the PFO tunnel, the first wing extends into the right atrium, and the second wing extends into the left atrium. Once implanted, the closure device is reconfigured such that the arm is seated within the PFO tunnel, the first wing folds against the septum secundum, and the second wing folds against the septum primum, thereby sealing the defect.

Abstract: The present invention provides devices and methods for closing a physical anomaly comprising two overlapping layers of tissue, such as a patent foramen ovale (“PFO”). A PFO is comprised of two overlapping layers of malformed interatrial septa, the septum primum and the septum secundum, that form a tunnel between the right atrium and the left atrium. The closure device includes two wings connected to a central arm. The device is delivered through the PFO tunnel in a substantially linear configuration such that the central arm is seated within the PFO tunnel, the first wing extends into the right atrium, and the second wing extends into the left atrium. Once implanted, the closure device is reconfigured such that the arm is seated within the PFO tunnel, the first wing folds against the septum secundum, and the second wing folds against the septum primum, thereby sealing the defect.

Abstract: An implantable heart monitor (IHM) implanted in a patient's body having electrogram (EGM) sense electrodes coupled with EGM sense circuitry to generate sense events upon detection of cardiac depolarizations and a blood pressure measurement transducer disposed in a heart chamber and coupled with blood pressure measurement circuitry operates to assess heart failure state as a function of mechanical pulsus alternans (MPA). MPA episodes are detected, and MPA characteristics of the MPA episode are used alone or as a group as a diagnostic marker of HF state. The MPA episode data set can be stored in memory associated with a time and date stamp. The MPA characteristics of each MPA data set in a series of MPA data sets collected over time can be compared or plotted to determine if a trend indicative of change in HF state is discernible.

Abstract: An implantable heart monitor (IHM) implanted in a patient's body having electrogram (EGM) sense electrodes coupled with EGM sense circuitry to generate sense events upon detection of cardiac depolarizations and a blood pressure measurement transducer disposed in a heart chamber and coupled with blood pressure measurement circuitry operates to assess heart failure state as a function of mechanical pulsus alternans (MPA). MPA episodes are detected, and MPA characteristics of the MPA episode are used alone or as a group as a diagnostic marker of HF state. The MPA episode data set can be stored in memory associated with a time and date stamp. The MPA characteristics of each MPA data set in a series of MPA data sets collected over time can be compared or plotted to determine if a trend indicative of change in HF state is discernible.