Abstract: Described is a prosthetic valve assembly comprising: a radially self-expandable stent configured to expand to bear against a wall of a native body lumen; and an implantable prosthetic valve, having a diameter, the valve being mounted inside the stent; wherein the diameter of the stent is greater than the diameter of the prosthetic valve.

Abstract: A system for modifying a heart valve annulus includes a helically helical anchored annuloplasty device delivered to the annulus via an elongated delivery member. The helical anchors of the devices disclosed herein are rotated into the valve annulus along an anchor guide by using a driver that is movably disposed in the delivery member. A tether is disposed within an inner channel of the helical anchor and a locking device is used to secure the annuloplasty device after the valve annulus has been modified. The annuloplasty device can be delivered to the annulus using, traditional surgical approach or a minimally invasive or catheter based methods.

Abstract: An aspiration catheter is provided in which rapid withdrawal of a piston disposed within a distal region of a catheter lumen creates a sudden pressure drop for ingestion of intravascular matter into the catheter lumen through a distal port while avoiding large losses of suction common with catheters having long aspiration lumens. Conventional aspiration using the same catheter can subsequently complement the procedure by fully removing the ingested matter from the catheter.

Abstract: A system and method for closing a percutaneous vessel puncture at the conclusion of a vascular catheterization procedure includes placement of an intravascular closure device having a radially and axially expandable tubular membrane and a radially expandable anchor at the distal end of the membrane. The closure device is placed, by a delivery catheter extending through the puncture site, with its anchor radially expanded in a location upstream of the puncture site to enable the force of a patient's blood flow to deploy the tubular membrane to a proximally extended configuration closing the puncture from within the vessel.

Abstract: A device and method for closing a percutaneous vascular puncture with anchors at the distal ends of wires temporarily implanted in extravascular tissue adjacent the puncture. The wires are tensioned to draw the tissue together to approximate the edges of the puncture. The wires are retained in that position while the blood in the region of the arteriotomy clots. When hemostasis has been achieved, the anchoring wires then can be removed.

Abstract: An aspiration catheter is provided in which vacuum may be accumulated within the catheter and released suddenly within a distal region of the catheter to induce ingestion of intravascular matter into the catheter through an open distal port while avoiding large losses of suction common with catheters having long aspiration lumens. Conventional aspiration using the same catheter can subsequently complement the procedure by fully removing the ingested matter from the catheter.

Abstract: A system and method for closing a percutaneous vessel puncture at the conclusion of a vascular catheterization procedure includes placement of an intravascular closure device having a radially and axially expandable tubular membrane and a radially expandable anchor at the distal sad of the membrane. The closure device is placed, by a delivery catheter extending through the puncture site, with its anchor radially expanded in a location upstream of the puncture site to enable the force of a patient's blood flow to deploy the tubular membrane to a proximally extended configuration closing the puncture from within the vessel.

Abstract: A double walled stent system particularly suited for treating abnormalities of the right ventricular outflow tract is disclosed having an exterior stent component and an interior stent component. The exterior stent component includes a plurality of longitudinally-extending connectors such as straight or sinusoidal bands. The interior stent component has a generally tubular cylindrical body and is centered within the exterior stent component. The stent system has a contracted delivery configuration and a radially expanded configuration for contacting the vessel wall. When deployed, the longitudinally-extending connectors of the exterior stent component come in contact with the vessel wall and fix the stent system to the treatment site. The interior stent component also radially expands but remains centered inside the exterior component and makes little to no contact with the vessel wall.

Abstract: A stent delivery system is disclosed that includes a recapture component for at least partially collapsing an improperly deployed stent in situ to permit repositioning and re-deployment of the stent. The recapture component and the stent may be disconnected in situ to allow for removal of the stent delivery system. In one embodiment, the recapture component is a balloon having loops or hooks around a periphery thereof for receiving at least one removable tether that couples the balloon and stent together. In another embodiment, the recapture component is an expandable tubular component connected to the stent via the removable tether.

Abstract: A closure device for an arteriotomy includes an elongate hollow shaft and an elongate driver slidably disposed therein. The elongate hollow shaft includes a pair of a pair of opposing actuation tips disposed at a distal end thereof defining a staple chamber there between. An anvil extends into the staple chamber from one of the actuation tips. The closure device includes a release mechanism for spreading apart the pair of opposing actuation tips to provide a gap associated with the anvil, the gap dimensioned such that the staple may pass there through. A method of using the closure device is also disclosed.

Abstract: A low profile, two lumen dilator is provided for an arteriotomy closure system. The dilator includes a first lumen adapted to receive a guidewire and a second lumen having a proximal segment that defines a blood marking lumen and a distal segment that receives the distal ends of stabilizers in a common pocket. The blood marking lumen and pocket are arranged in tandem. The guidewire lumen may extend the full length of the dilator or may be shortened to provide rapid exchange capability.

Abstract: A method for modifying a heart valve annulus includes placing a purse string suture at a puncture site adjacent a heart valve, inserting at least one delivery member through the puncture site, positioning a distal end of the at least one delivery member adjacent a portion of a valve annulus, deploying an annuloplasty device carried within the at least one delivery member and implanting the annuloplasty device into the valve annulus. The method also includes reshaping the heart valve annulus after implantation of the at least one annuloplasty device.

Abstract: Described is a prosthetic valve assembly comprising: a radially self-expandable stent configured to expand to bear against a wall of a native body lumen; and an implantable prosthetic valve, having a diameter, the valve being mounted inside the stent; wherein the diameter of the stent is greater than the diameter of the prosthetic valve.

Abstract: A closure device for an arteriotomy includes an elongate tube having a distal opening, a staple disposed within the tube, and a frangible cap mounted across the distal opening to guard the staple tips against contact with the tissue track. The frangible cap is pierced, fractured or torn when the staple is advanced through the distal opening. A portion of the torn frangible cap may be implanted with the staple as a pledget. The staple may be carried within the elongate tube by a stapler comprising an elongate hollow shaft and an elongate driver slidably disposed therein. A pair of opposing actuation tips is disposed at a distal end of the hollow shaft to define an open-sided staple chamber there between. An anvil is fixedly disposed within the staple chamber, which holds at least a proximal portion of the staple.

Abstract: An aspiration catheter is provided in which rapid withdrawal of a piston disposed within a distal region of a catheter lumen creates a sudden pressure drop for ingestion of intravascular matter into the catheter lumen through a distal port while avoiding large losses of suction common with catheters having long aspiration lumens. Conventional aspiration using the same catheter can subsequently complement the procedure by fully removing the ingested matter from the catheter.

Abstract: An aspiration catheter is provided in which vacuum may be accumulated within the catheter and released suddenly within a distal region of the catheter to induce ingestion of intravascular matter into the catheter through an open distal port while avoiding large losses of suction common with catheters having long aspiration lumens. Conventional aspiration using the same catheter can subsequently complement the procedure by fully removing the ingested matter from the catheter.

Abstract: A device and method for closing a percutaneous vascular puncture with anchors at the distal ends of wires temporarily implanted in extravascular tissue adjacent the puncture. The wires are tensioned to draw the tissue together to approximate the edges of the puncture. The wires are retained in that position while the blood in the region of the arteriotomy clots. When hemostasis has been achieved, the anchoring wires then can be removed.

Abstract: A catheter for use in a medical procedure includes an elongate outer member, an elongate inner member and an expandable distal tip attached to a distal most end of at least one of the outer member or inner member, wherein the distal tip has a first shape and a second shape and the tip can be easily transformed between the first and second shapes to aid in navigation through a patient's vascular system. A method of using the catheter includes inserting the catheter into the vascular system, navigating the distal end of the catheter through the vascular system, determining an obstruction within the vascular system, modifying the expandable tip from the first shape to the second shape in response to the determination of the obstruction, advancing the modified expandable tip passed the determined obstruction and returning the modified expandable tip to the first shape upon passing the determined obstruction.

Abstract: A double walled stent system particularly suited for treating abnormalities of the right ventricular outflow tract is disclosed having an exterior stent component and an interior stent component. The exterior stent component includes a plurality of longitudinally-extending connectors such as straight or sinusoidal bands. The interior stent component has a generally tubular cylindrical body and is centered within the exterior stent component. The stent system has a contracted delivery configuration and a radially expanded configuration for contacting the vessel wall. When deployed, the longitudinally-extending connectors of the exterior stent component come in contact with the vessel wall and fix the stent system to the treatment site. The interior stent component also radially expands but remains centered inside the exterior component and makes little to no contact with the vessel wall.

Abstract: Devices and methods for closing an arteriotomy include a percutaneously placeable central tube deployable about the arteriotomy by which an array of radially expandable fingers having suction ports can be engaged with the surface of tissue about the arteriotomy enabling the fingers to grip the tissue without piercing it. A delivery tube can advance a closure element along the outside surface of the central tube, thereby radially contracting the fingers and puckering the gripped tissue to approximate the edges of the arteriotomy. The closure element is further advanced until it is forced off of the distal tips of the fingers such that the closure element surrounds the puckered tissue and secures permanent closure of the arteriotomy.