A system or device for isolating pulmonary pressure from left atrial pressure and/or improving cardiac output. The device may be an implantable cardiac device comprising an intravascular shield. The system may comprise an intravascular shield and a trans-septal delivery sheath. The intravascular shield can be sized and configured to be positioned in a pulmonary vein or a left atrium to restrict fluid flow from the left atrium through one or more pulmonary veins to the lungs while allowing fluid flow from the lungs through the one or more pulmonary veins to the left atrium. The trans-septal delivery sheath can be configured to contain the intravascular shield in a collapsed configuration and deliver the intravascular shield to the left atrium.

Apparatus for securing an object to bone, the apparatus comprising: an anchor assembly comprising an anchor and an actuation element extending from the anchor, wherein applying a force to the actuation element when the anchor is disposed in a hole formed in a bone secures the anchor to the bone; and an inserter for deploying the anchor assembly in a hole formed in a bone, the inserter comprising: a shaft for releasably engaging the anchor; and a force delivery mechanism mounted to the shaft and connected to the actuation element, the force delivery mechanism being constructed so as to receive an input force from an external source and to selectively apply an output force to the actuation element, with the force delivery mechanism being constructed so that the magnitude of the output force is limited regardless of the magnitude of the input force.

Apparatus and methods are described herein for anchoring a prosthetic heart valve. In some embodiments, an apparatus includes a tether attachment member that includes a base member that defines at least a portion of a tether passageway through which a portion of a tether extending from a prosthetic heart valve can be received therethrough. The base member defines a locking pin channel that intersects the tether passageway. A locking pin is disposable within the locking pin channel and movable between a first position in which the locking pin is at a spaced distance from the tether passageway, and a second position in which the locking pin intersects the tether passageway and can engage the portion of a tether disposed therein to secure the tether to the tether attachment member.

The disclosure provides a device and method for managing urinary incontinence. The device includes a platform, a balloon, and a valve. The platform and balloon can include a silicone material, a thermoplastic material, and an adhesive and/or a cement for sealing the urethra. The thermoplastic and silicone materials can soften at the body temperature so that their shape can be adapted to fit the three-dimensional contour of surfaces of the urethra. The balloon seals the internal orifice of the urethra, and the platform can block the leakage associated with the balloon. The valve permits selective urine voiding. The method includes inserting the device into the urethra and the bladder. The method can also include inflating the balloon. The method can further include pulling the balloon so that the balloon is in sealing contact with the neck of the bladder and moving the platform to a suitable position for sealing the urethra.

An apparatus for repairing or replacing a mitral valve and a method of using same are disclosed. The apparatus has an atrial band securable to a ring-shaped ventricular band. The ventricular band has an anterior band and a posterior band connectable to the anterior band. The atrial and anterior bands each have a pair of apertures. Each of the apertures is positioned proximate to a respective terminal end of the bands. The apertures of the atrial and anterior bands are arranged to align with one another when their inner surfaces engage. Means are provided to secure the atrial band to the anterior band. When delivered and implanted, the apparatus is arranged to extend across the commissures of the heart, with atrial and anterior bands arranged to press against the atrial and ventricular surfaces of the mitral valve leaflets respectively.

Prosthetic heart valves described herein can be deployed using a transcatheter delivery system and technique to interface and anchor in cooperation with the anatomical structures of a native heart valve. Some embodiments of prosthetic valves described herein include an anchor portion that couples to the anatomy near a native valve, and a valve portion that is mateable with the anchor portion. In some such embodiments, the anchor portion and/or the deployment system includes one or more prosthetic elements that temporarily augment or replace the sealing function of the native valve leaflets.

Ureteral or bladder catheters are provided, including (a) a proximal portion; and (b) a distal portion, the distal portion including a retention portion that includes one or more protected drainage holes, ports or perforations and is configured to establish an outer periphery or protective surface area that inhibits mucosal tissue from occluding the one or more protected drainage holes, ports or perforations upon application of negative pressure through the catheter. Systems, kits and methods for inducing negative pressure to increase renal function also are provided.

Some embodiments of the present disclosure are directed generally to systems and methods for delivering an implant to a body vessel of a patient. Such disclosed implants may be a monofilament implant, and disclosed systems for implanting the implant may be automatic. Some embodiments may enable retraction of said implant back into the delivery system following partial exteriorization of the implant from the delivery system. Some embodiments may be configured for retraction of said implant from the patient's body following complete exteriorization of the implant from the delivery system. Some of the embodiments are directed at delivering a monofilament implant for preventing embolic stroke. Other embodiments are directed at preventing pulmonary embolism, occluding a body vessel such as the left atrial appendage, occluding a body passageway such as a patent foramen ovalae, stenting a body vessel, or releasing a local therapeutic agent such as a drug or ionizing radiation.

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 having one or more engagers disposed thereon configured to releasably engage with a first expandable end of the shunt in a contracted delivery state within a lumen of a sheath, and a 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. The inventive devices may be used, for example, to treat subjects having heart failure, pulmonary congestion, or myocardial infarction, among other pathologies.

An annuloplasty device is disclosed for treating a defective mitral valve having an annulus, comprising a removable and flexible elongate displacement unit for temporary insertion into a coronary sinus (CS) adjacent the valve, wherein the displacement unit has a delivery state for delivery into the CS, and an activated state to which the displacement unit is temporarily and reversibly transferable from said delivery state, the displacement unit comprises a proximal reversibly expandable portion, a distal anchoring portion being movable in relation to the proximal expandable portion in a longitudinal direction of the displacement unit to said activated state in which the shape of the annulus is modified to a modified shape, wherein the proximal expandable portion is reversibly foldable to an expanded state for positioning against a tissue wall at the entrance of the CS.