Abstract: Catheter apparatuses and methods are provided for repairing heart valves, particularly mitral valves. The method includes providing a catheter having an elongate, flexible body, with a proximal end and a distal end. The distal end can be transluminally advanced from the left atrium through the mitral valve and along the left ventricular outflow tract into the ascending aorta. A valve repair device is deployed to permanently connect leaflets at a mid-section of a mitral valve while permitting medial and lateral portions of the natural leaflets to open and close. The valve repair device detachably connects the distal and proximal ends of the catheter.

Abstract: A system and method of accessing a heart of a patient is provided. A cardiac access channel is established through an apical wall of the heart to provide direct access through the apical wall to the left ventricle. A vascular access channel is established through the skin to a peripheral blood vessel. A first end of an elongate member is advanced from the outside of the apical wall through the cardiac access channel and into the left ventricle. A second end disposed opposite the first end remains outside the patient. The elongate member is drawn into and through the vascular access channel to externalize the first end of the elongate member while leaving the second end outside the apical wall of the heart.

Abstract: A heart valve prosthesis is provided that includes a first member and a second member. The first member comprises a first central portion to be disposed adjacent to a line of coaptation on a first side of two adjacent heart leaflets and peripheral portions to be placed into direct contact with the two adjacent heart leaflets. The second member is separate from or can be separable from the first member, for example during delivery. The second member has a central portion and peripheral portions configured to be placed into direct contact with a second side of the two adjacent heart leaflets.

Abstract: A heart valve prosthesis is provided that includes a first member and a second member. The first member comprises a first central portion to be disposed adjacent to a line of coaptation on a first side of two adjacent heart leaflets and peripheral portions to be placed into direct contact with the two adjacent heart leaflets. The second member is separate from or can be separable from the first member, for example during delivery. The second member has a central portion and peripheral portions configured to be placed into direct contact with a second side of the two adjacent heart leaflets.

Abstract: A fixation device for securing together leaflets of a heart valve is provided. The fixation device may comprise two plates that are disposed on either side of the tricuspid valve. The plates may be secured to one another by a locking clip, thereby securing the valve leaflets between the plates.

Abstract: Devices and methods for treating tricuspid regurgitation (TR) are provided. A clasp or clamp is used to anchor a TR-treatment device to an existing lead of a pacemaker or an implantable cardioverter defibrillator (ICD) that passes through the tricuspid valve. The TR-treatment device can be a balloon occluder that is adjustable by filling or withdrawing filler material from the occluder through a proximal port implanted in the skin of the patient.

Abstract: A fixation device for securing together leaflets of a heart valve is provided. The fixation device may comprise two plates that are disposed on either side of the tricuspid valve. The plates may be secured to one another by a locking clip, thereby securing the valve leaflets between the plates.

Abstract: Catheter apparatuses and methods are provided for repairing heart valves, particularly mitral valves. The method includes providing a catheter having an elongate, flexible body, with a proximal end and a distal end. The distal end can be transluminally advanced from the left atrium through the mitral valve. A distal anchor zone or portion coupled with the proximal end can extend and along the left ventricular outflow tract into the ascending aorta. A valve repair device is deployed to permanently connect leaflets at a mid-section of a mitral valve while permitting medial and lateral portions of the natural leaflets to open and close. The catheter apparatuses may be positionable using a steering device. The valve repair device detachably connects the distal and proximal ends of the catheter. The valve repair device can be detached using low profile devices actuatable from the proximal or distal ends, e.g., at a venous or arterial access site.

Abstract: A delivery system for rapid placement of heart implants is provided that includes a delivery platform. The delivery system includes a tubular catheter body, a piercing member, and a delivery platform. The tubular catheter body is sufficiently long and flexible to be advanced from a peripheral blood vessel access site to an atrium of the heart. The piercing member is configured to create a transapical channel from an internal apical portion of a ventricle to an outside heart wall. The delivery system includes an elongate tension member and an enlargeable member disposed on a distal portion of the elongate tension member. The enlargeable member is configured to be enlarged in a pericardial space of an intact chest wall to cover an area of the outside heart wall surrounding an opening of the transapical channel. When tensioned, the tension member provides a stable zone for positioning a heart implant within the heart.

Abstract: Devices and methods for treating tricuspid regurgitation (TR) are provided. A clasp or clamp is used to anchor a TR-treatment device to an existing lead of a pacemaker or an implantable cardioverter defibrillator (ICD) that passes through the tricuspid valve. The TR-treatment device can be a balloon occluder that is adjustable by filling or withdrawing filler material from the occluder through a proximal port implanted in the skin of the patient.

Abstract: A system and method of accessing a heart of a patient is provided. A cardiac access channel is established through an apical wall of the heart to provide direct access through the apical wall to the left ventricle. A vascular access channel is established through the skin to a peripheral blood vessel. A first end of an elongate member is advanced from the outside of the apical wall through the cardiac access channel and into the left ventricle. A second end disposed opposite the first end remains outside the patient. The elongate member is drawn into and through the vascular access channel to externalize the first end of the elongate member while leaving the second end outside the apical wall of the heart.

Abstract: Catheter apparatuses and methods are provided for repairing heart valves, particularly mitral valves. The method includes providing a catheter having an elongate, flexible body, with a proximal end and a distal end. The distal end can be transluminally advanced from the left atrium through the mitral valve. A distal anchor zone or portion coupled with the proximal end can extend and along the left ventricular outflow tract into the ascending aorta. A valve repair device is deployed to permanently connect leaflets at a mid-section of a mitral valve while permitting medial and lateral portions of the natural leaflets to open and close. The catheter apparatuses may be positionable using a steering device. The valve repair device detachably connects the distal and proximal ends of the catheter. The valve repair device can be detached using low profile devices actuatable from the proximal or distal ends, e.g., at a venous or arterial access site.

Abstract: A system and method of accessing a heart of a patient is provided. A cardiac access channel is established through an apical wall of the heart to provide direct access through the apical wall to the left ventricle. A vascular access channel is established through the skin to a peripheral blood vessel. A first end of an elongate member is advanced from the outside of the apical wall through the cardiac access channel and into the left ventricle. A second end disposed opposite the first end remains outside the patient. The elongate member is drawn into and through the vascular access channel to externalize the first end of the elongate member while leaving the second end outside the apical wall of the heart.

Abstract: Methods and devices are disclosed for minimally invasive procedures in the heart. In one application, a catheter is advanced from the left atrium through the mitral valve and along the left ventricular outflow tract to orient and stabilize the catheter and enable a procedure such as a “bow tie” repair of the mitral valve. Right heart procedures are also disclosed.

Abstract: A heart valve prosthesis is provided that includes a first member and a second member. The first member comprises a first central portion to be disposed adjacent to a line of coaptation on a first side of two adjacent heart leaflets and peripheral portions to be placed into direct contact with the two adjacent heart leaflets. The second member is separate from or can be separable from the first member, for example during delivery. The second member has a central portion and peripheral portions configured to be placed into direct contact with a second side of the two adjacent heart leaflets.

Abstract: A fixation device for securing together leaflets of a heart valve is provided. The fixation device may comprise two plates that are disposed on either side of the tricuspid valve. The plates may be secured to one another by a locking clip, thereby securing the valve leaflets between the plates.

Abstract: A delivery system for rapid placement of heart implants is provided that includes a delivery platform. The delivery system includes a tubular catheter body, a piercing member, and a delivery platform. The tubular catheter body is sufficiently long and flexible to be advanced from a peripheral blood vessel access site to an atrium of the heart. The piercing member is configured to create a transapical channel from an internal apical portion of a ventricle to an outside heart wall. The delivery system includes an elongate tension member and an enlargeable member disposed on a distal portion of the elongate tension member. The enlargeable member is configured to be enlarged in a pericardial space of an intact chest wall to cover an area of the outside heart wall surrounding an opening of the transapical channel. When tensioned, the tension member provides a stable zone for positioning a heart implant within the heart.

Abstract: Catheter apparatuses and methods are provided for repairing heart valves, particularly mitral valves. The method includes providing a catheter having an elongate, flexible body, with a proximal end and a distal end. The distal end can be transluminally advanced from the left atrium through the mitral valve and along the left ventricular outflow tract into the ascending aorta. A valve repair device is deployed to permanently connect leaflets at a mid-section of a mitral valve while permitting medial and lateral portions of the natural leaflets to open and close. The valve repair device detachably connects the distal and proximal ends of the catheter.

Abstract: Catheter apparatuses and methods are provided for repairing heart valves, particularly mitral valves. The method includes providing a catheter having an elongate, flexible body, with a proximal end and a distal end. The distal end can be transluminally advanced from the left atrium through the mitral valve and along the left ventricular outflow tract into the ascending aorta. A valve repair device is deployed to permanently connect leaflets at a mid-section of a mitral valve while permitting medial and lateral portions of the natural leaflets to open and close. The valve repair device detachably connects the distal and proximal ends of the catheter.

Abstract: A delivery system for rapid placement of heart implants is provided that includes a delivery platform. The delivery system includes a tubular catheter body, a piercing member, and a delivery platform. The tubular catheter body is sufficiently long and flexible to be advanced from a peripheral blood vessel access site to an atrium of the heart. The piercing member is configured to create a transapical channel from an internal apical portion of a ventricle to an outside heart wall. The delivery system includes an elongate tension member and an enlargeable member disposed on a distal portion of the elongate tension member. The enlargeable member is configured to be enlarged in a pericardial space of an intact chest wall to cover an area of the outside heart wall surrounding an opening of the transapical channel. When tensioned, the tension member provides a stable zone for positioning a heart implant within the heart.