Abstract: A temporary pacing lead has an atraumatic curled distal region with multiple cathodes and distal pressure measurement to allow positioning and repositioning within the heart chamber without fluoroscopic or echo guidance. The curled distal region provides definite contact with two opposing walls of the ventricular chamber to ensure electrical signal capture without trauma to the endocardial surface. A stylet located in the pacing lead lumen assists in introducing, placing, and removing the pacing lead from the heart. The flexible distal region provides safe removal of the temporary lead following completion of use.

Abstract: A trans-atrial septal catheter system for delivery of a steerable sheath into the left atrium contains three components. The first component is a three-segmented needle-guide wire composed of a distal needle designed to flex sharply in relation to the conjoined looped guide wire segment after fossa ovalis puncture and needle advancement. The distal guide wire loops are advanced into the left atrium maintaining the angled needle in a central location relevant to the loops for preserving an atraumatic position while stabilizing the loops in the left atrium. The elongated proximal extra stiff guide wire segment is conjoined to the looped segment which crosses the fossa ovalis and extends proximally to become externalized to the femoral vein. This segment is extra stiff and significantly elongated to permit catheter and device exchanges. The guide wire serves as a support rail over which the dilator and sheath can be advanced into the left atrium.

Abstract: A retrieval catheter and methods of use are described for removing a heart valve therapy such as a leaflet clip or artificial leaflet cord. The retrieval catheter can include a cutting element and a basket, piercing element, clamping mechanism, or similar grasping device. The method includes delivering a catheter to the region of the heart valve therapy and then manipulating the catheter and associated instruments to cut tissue as necessary and then remove the heart valve therapy and withdraw the catheter.

Abstract: Anatomical wall crossing systems, devices and related methods are disclosed in this patent document. A transseptal system, for example, can include a guidewire, a dilator, and a deflectable sheath configured to safely deliver a puncture needle through a septal wall associated with the fossa ovalis and into a central region of the left atrium of a heart. The dilator can include a dilator nose having a first outer diameter and a dilator beveled segment, extending proximal of the dilator nose, tapering from a second, greater outer diameter to the first outer diameter. The length and interplay of the puncture needle and the dilator nose can be configured such that the puncture needle is inhibited from bending and impinging upon the left side of the atrial septum of the heart during use. A body of the guidewire can include at least one loop segment to provide stable support in the left atrium for delivery of a diagnostic or therapeutic device along its more proximal portions.

Abstract: A temporary pacing lead has an atraumatic curled distal region with multiple cathodes and distal pressure measurement to allow positioning and repositioning within the heart chamber without fluoroscopic or echo guidance. The curled distal region provides definite contact with two opposing walls of the ventricular chamber to ensure electrical signal capture without trauma to the endocardial surface. A stylet located in the pacing lead lumen assists in introducing, placing, and removing the pacing lead from the heart. The flexible distal region provides safe removal of the temporary lead following completion of use.

Abstract: Systems, devices and methods for percutaneously modifying leaflets within the heart, thereby facilitating further repair or replacement. In some embodiments, the leaflets are cut. In other embodiments, the leaflets are removed either in part or in whole. The modifications to the leaflets may be made in conjunction with a prosthetic valve or independently.

Abstract: Various aspects of the present disclosure are directed toward apparatuses, systems, and methods for cardiac device anchoring and more specifically to accessing and anchoring in the pericardial space.

Abstract: Various aspects of the present disclosure are directed toward apparatuses, systems, and methods for cardiac device anchoring and more specifically to accessing and anchoring in the pericardial space.

Abstract: A retrieval catheter and methods of use are described for removing a heart valve therapy such as a leaflet clip or artificial leaflet cord. The retrieval catheter can include a cutting element and a basket, piercing element, clamping mechanism, or similar grasping device. The method includes delivering a catheter to the region of the heart valve therapy and then manipulating the catheter and associated instruments to cut tissue as necessary and then remove the heart valve therapy and withdraw the catheter.

Abstract: A guide wire that has an atraumatic and flexible loop that expands within a vessel, with indicators that indicate the degree of expansion. The indicators are used to determine the degree of expansion through the use of radio-opaque markers, hydraulic, and electrical signals. The guide wire enables safe passage into target vessels while providing user feedback on inadvertent passage into side branches and diseased segments.

Abstract: A pacing lead for temporary atraumatic placement via transvascular access on an endocardial surface of a heart chamber of an animal body. The pacing lead body has a curled shaft at the distal end region of the pacing lead body having a plurality of electrode sites. Each of the electrode sites is individually connected via an electrode conduction wire to a switch box, which receives generator signals from a pulse generator and directs the electrode generator signal to specific electrode sites. A push-pull element is connected to the lead body distal end. A tension-compression member connects to the push-pull element and provides tension and compression to the push-pull element.

Abstract: A leaflet repair device for a heart valve of a human heart comprises an implantable leaflet with a coaptation edge; a repair chord connected at one end to near the coaptation edge; a chord anchor for anchoring the repair chord to native structure of the human heart; and at least one annulus anchor for anchoring the leaflet to native structure of the human heart. In at least one embodiment, the leaflet repair device may overlap a diseased, prolapsed, or otherwise inferior leaflet that is not creating proper coaptation with a mating leaflet.

Abstract: A trans-atrial septal catheter system for delivery of a steerable sheath into the left atrium contains three components. The first component is a three-segmented needle-guide wire composed of a distal needle designed to flex sharply in relation to the conjoined looped guide wire segment after fossa ovalis puncture and needle advancement. The distal guide wire loops are advanced into the left atrium maintaining the angled needle in a central location relevant to the loops for preserving an atraumatic position while stabilizing the loops in the left atrium. The elongated proximal extra stiff guide wire segment is conjoined to the looped segment which crosses the fossa ovalis and extends proximally to become externalized to the femoral vein. This segment is extra stiff and significantly elongated to permit catheter and device exchanges. The guide wire serves as a support rail over which the dilator and sheath can be advanced into the left atrium.

Abstract: A functional gadolinium contrast agent comprising a gadolinium cation and a ligand secured to the gadolinium cation is disclosed, the ligand comprising a reactive group capable of bonding to a capture substrate. A method of removing gadolinium contrast agents from a patient is disclosed, the method comprising providing a gadolinium contrast agent containing a reactive group; providing a capture substrate for insertion into a patient's bloodstream; administering the gadolinium contrast agent to the patient; conducting a magnetic resonance imaging procedure; and sequestering the gadolinium contrast agent on the capture substrate. A system for removing gadolinium contrast agents is also disclosed.

Abstract: A trans-atrial septal catheter system for delivery of a steerable sheath into the left atrium contains three components. The first component is a three-segmented needle-guide wire composed of a distal needle designed to flex sharply in relation to the conjoined looped guide wire segment after fossa ovalis puncture and needle advancement. The distal guide wire loops are advanced into the left atrium maintaining the angled needle in a central location relevant to the loops for preserving an atraumatic position while stabilizing the loops in the left atrium. The elongated proximal extra stiff guide wire segment is conjoined to the looped segment which crosses the fossa ovalis and extends proximally to become externalized to the femoral vein. This segment is extra stiff and significantly elongated to permit catheter and device exchanges. The guide wire serves as a support rail over which the dilator and sheath can be advanced into the left atrium.

Abstract: An imaging contrast composition comprising an iodinated contrast agent and a ligand secured to the iodinated contrast agent is disclosed, the ligand comprising a reactive group capable of bonding to a capture substrate. A method of removing iodinated radiocontrast agents from a patient is disclosed, the method comprising providing an iodinated radiocontrast agent containing a reactive group; providing a capture substrate for insertion into a patient's bloodstream; administering the iodinated radiocontrast agent to the patient; conducting procedure CT scan or procedure using fluoroscopy; and sequestering the iodinated radiocontrast agent on the capture substrate.

Abstract: Methods and devices for closing tissue apertures in a patient, such as PFO, are disclosed. A suturing device is used to place a suture through areas of tissue that are intended to be closed. Pledgets or buttons can be placed on the suture and each side of the tissue to help maintain the closure.

Abstract: A temporary pacing lead has an atraumatic curled distal region with multiple cathodes and distal pressure measurement to allow positioning and repositioning within the heart chamber without fluoroscopic or echo guidance. The curled distal region provides definite contact with two opposing walls of the ventricular chamber to ensure electrical signal capture without trauma to the endocardial surface. A stylet located in the pacing lead lumen assists in introducing, placing, and removing the pacing lead from the heart. The flexible distal region provides safe removal of the temporary lead following completion of use.

Abstract: An imaging contrast composition comprising an iodinated contrast agent and a ligand secured to the iodinated contrast agent is disclosed, the ligand comprising a reactive group capable of bonding to a capture substrate. A method of removing iodinated radiocontrast agents from a patient is disclosed, the method comprising providing an iodinated radiocontrast agent containing a reactive group; providing a capture substrate for insertion into a patient's bloodstream; administering the iodinated radiocontrast agent to the patient; conducting procedure CT scan or procedure using fluoroscopy; and sequestering the iodinated radiocontrast agent on the capture substrate.

Abstract: A functional gadolinium contrast agent comprising a gadolinium cation and a ligand secured to the gadolinium cation is disclosed, the ligand comprising a reactive group capable of bonding to a capture substrate. A method of removing gadolinium contrast agents from a patient is disclosed, the method comprising providing a gadolinium contrast agent containing a reactive group; providing a capture substrate for insertion into a patient's bloodstream; administering the gadolinium contrast agent to the patient; conducting a magnetic resonance imaging procedure; and sequestering the gadolinium contrast agent on the capture substrate. A system for removing gadolinium contrast agents is also disclosed.