Abstract: A suture-based vessel closure device can perform the dilation of an arteriotomy puncture and does not require previous dilation of the arteriotomy puncture by a separate device or by a procedural sheath dilator. The suture-based vessel closure device can place one or more sutures across the vessel access site such that, when the suture ends are tied off after sheath removal, the stitch or stitches provide hemostasis to the access site.

Abstract: A retrograde flow system is configured for treating an artery. The system includes an arterial access device adapted to be introduced into an artery and receive blood flow from the artery. A shunt fluidly is connected to the arterial access device, wherein the shunt provides a pathway for blood to flow from the arterial access device to a return site. A flow control assembly is coupled to the shunt and is adapted to regulate blood flow through the shunt between at least a first blood flow state and at least a second blood flow state. A shut-off valve assembly automatically blocks fluid flow through the shunt in response to injection of the fluid into the arterial access device.

Abstract: A retrograde flow system is configured for treating an artery. The system includes an arterial access device adapted to be introduced into an artery and receive blood flow from the artery. A shunt fluidly is connected to the arterial access device, wherein the shunt provides a pathway for blood to flow from the arterial access device to a return site. A flow control assembly is coupled to the shunt and is adapted to regulate blood flow through the shunt between at least a first blood flow state and at least a second blood flow state. A shut-off valve assembly automatically blocks fluid flow through the shunt in response to injection of the fluid into the arterial access device.

Abstract: Systems and methods are adapted for treating the carotid artery. The systems include interventional catheters and blood vessel access devices that are adapted for transcervical insertion into the carotid artery. Embodiments of the systems and methods can be used in combination with embolic protection systems including blood flow reversal mechanisms, arterial filters, and arterial occlusion devices.

Abstract: Methods and apparatus for treating gastroesophageal reflex and other luminal conditions provide for delivering acoustic energy to a body lumen to remodel tissue surrounding the body lumen. In the case of treating GERD, a catheter carrying an ultrasonic or other vibrational transducer is introduced to the lower esophageal sphincter, and acoustic energy is delivered to the sphincter in order to tighten or bulk the sphincter such that reflex is reduced.

Abstract: Described are methods and systems for transcervical access of the cerebral arterial vasculature and treatment of cerebral occlusions, including ischemic stroke. The methods and devices may include methods and devices which may provide aspiration and passive flow reversal, those which protect the cerebral penumbra during the procedure to minimize injury to brain, as well as distal catheters and devices to remove an occlusion. The methods and devices that provide passive flow reversal may also offer to the user a degree of flow control. Devices and methods which provide a way to securely close the access site in the carotid artery to avoid the potentially devastating consequences of a transcervical hematoma are also described.

Abstract: A tissue ablation device assembly ablates a region of tissue in a body of a patient. The tissue ablation device assembly comprises an elongated body having a proximal end portion and a distal end portion. A tubular porous membrane having a porous wall with an inner surface that defines an inner space is located along the distal end portion of the elongated body. An ablation element is disposed over the porous membrane, with the ablation element having a fixed position with respect to the porous membrane. A fluid passageway extending through the elongated body and communicates with the inner space. The fluid passageway is adapted to be fluidly coupled to a pressurizeable fluid source for delivering a volume of pressurized fluid from the fluid source to the inner space. The porous membrane allows at least a substantial portion of the volume of pressurized fluid to pass through the porous wall for enhancing ablative coupling between the electrode and the region of tissue.

Abstract: The present invention relates to an anchor device comprising an elongated tubular body having an expandable member disposed on its distal end portion. The invention also relates to a system adapted to position and anchor the distal end of an ablation device at a location where a pulmonary vein extends from the atrium.

Abstract: A retrograde flow system is configured for treating an artery. The system includes an arterial access device adapted to be introduced into an artery and receive blood flow from the artery. A shunt fluidly is connected to the arterial access device, wherein the shunt provides a pathway for blood to flow from the arterial access device to a return site. A flow control assembly is coupled to the shunt and is adapted to regulate blood flow through the shunt between at least a first blood flow state and at least a second blood flow state. A shut-off valve assembly automatically blocks fluid flow through the shunt in response to injection of the fluid into the arterial access device.

Abstract: A clip-based vascular closure devices is configured to be pre-applied to a blood vessel prior to insertion of a vascular access device (such as a procedural sheath) through an incision, puncture, penetration or other passage through the blood vessel. In an embodiment, the disclosed closure device is applied in a carotid artery via a transcervical access such as by forming an incision in the patient's neck to in order to access the blood vessel or other body lumen.

Abstract: The present invention relates to a system adapted to position a medical device, such as an ablation catheter, at a location where a pulmonary vein extends from an atrium. The system optimally includes a deflectable catheter and a sheath. An ablation member is disclosed for use with the positioning system, wherein the deflectable catheter and the sheath cooperate so as to facilitate positioning of the ablation member at the location.

Abstract: A tissue ablation device assembly ablates a region of tissue in a body of a patient. The tissue ablation device assembly comprises an elongated body having a proximal end portion and a distal end portion. A tubular porous membrane having a porous wall with an inner surface that defines an inner space is located along the distal end portion of the elongated body. An ablation element is disposed over the porous membrane, with the ablation element having a fixed position with respect to the porous membrane. A fluid passageway extending through the elongated body and communicates with the inner space. The fluid passageway is adapted to be fluidly coupled to a pressurizeable fluid source for delivering a volume of pressurized fluid from the fluid source to the inner space. The porous membrane allows at least a substantial portion of the volume of pressurized fluid to pass through the porous wall for enhancing ablative coupling between the electrode and the region of tissue.

Abstract: An intravascular device for the formation of linear lesions which has particular utility in the treatment of atrial fibrillation and flutter. The intravascular device has an outer delivery member with a distal section which has an elongated opening and a support element coextending with the opening. An EP device having a plurality of electrodes on its distal section is slidably disposed within the inner lumen of the delivery member but it is secured by its distal end within the distal extremity of the delivery member at least while in operation. In this manner an axial force in the proximal direction on the proximal extremity of the EP device, which extends out of the patient during the procedure, will cause the distal shaft section of the EP device to arch outwardly out of and away from the distal section of the delivery shaft along an inner side of the curved distal section and engage the surface of the patient's heart chamber.

Abstract: An intravascular device for the formation of linear lesions which has particular utility in the treatment of atrial fibrillation and flutter. The intravascular device has an outer delivery member with a distal section which has an elongated opening and a support element coextending with the opening. An EP device having a plurality of electrodes on its distal section is slidably disposed within the inner lumen of the delivery member but it is secured by its distal end within the distal extremity of the delivery member at least while in operation. In this manner an axial force in the proximal direction on the proximal extremity of the EP device, which extends out of the patient during the procedure, will cause the distal shaft section of the EP device to arch outwardly out of and away from the distal section of the delivery shaft along an inner side of the curved distal section and engage the surface of the patient's heart chamber.

Abstract: A tissue ablation device assembly ablates a region of tissue in a body of a patient. The tissue ablation device assembly comprises an elongated body having a proximal end portion and a distal end portion. A tubular porous membrane having a porous wall with an inner surface that defines an inner space is located along the distal end portion of the elongated body. An ablation element is disposed over the porous membrane, with the ablation element having a fixed position with respect to the porous membrane. A fluid passageway extending through the elongated body and communicates with the inner space. The fluid passageway is adapted to be fluidly coupled to a pressurizeable fluid source for delivering a volume of pressurized fluid from the fluid source to the inner space. The porous membrane allows at least a substantial portion of the volume of pressurized fluid to pass through the porous wall for enhancing ablative coupling between the electrode and the region of tissue.

Abstract: A tissue ablation catheter for forming a lesion along a substantially circumferential region of tissue is described. The catheter includes one or more sensors for monitoring the temperature of the tissue being ablated. The temperature sensors are mounted on the interior or exterior of an expandable member that is affixed to a shaft of the catheter.

Abstract: Disclosed is a method for attaching a sensor to an inflatable balloon. The method involves bonding the sensor to the balloon with an adhesive while the balloon is in an expanded state and then collapsing the balloon after the adhesive has at least partially cured. The method reduces the possibility of a failure of the bond between the sensor and the balloon. The method is particularly useful in the construction of a tissue ablation catheter for forming a lesion along a substantially circumferential region of tissue wherein a sensor is used for monitoring the temperature of the tissue being ablated.

Abstract: An intravascular device for the formation of linear lesions which has particular utility in the treatment of atrial fibrillation and flutter. The intravascular device has an outer delivery member with a distal section which has an elongated opening and a support element coextending with the opening. An EP device having a plurality of electrodes on its distal section is slidably disposed within the inner lumen of the delivery member but it is secured by its distal end within the distal extremity of the delivery member at least while in operation. In this manner an axial force in the proximal direction on the proximal extremity of the EP device, which extends out of the patient during the procedure, will cause the distal shaft section of the EP device to arch outwardly out of and away from the distal section of the delivery shaft along an inner side of the curved distal section and engage the surface of the patient's heart chamber.

Abstract: The present invention is a system adapted to position an ablation catheter at a location where a pulmonary vein extends from an atrium. The system includes a deflectable guidewire and a sheath. The ablation catheter is used with the positioning system, wherein the deflectable guidewire and the sheath cooperate so as to facilitate positioning of the catheter at the location.

Abstract: The present invention relates to a system adapted to position a medical device, such as an ablation catheter, at a location where a pulmonary vein extends from an atrium. The system optimally comprises a deflectable catheter and a sheath. An ablation member is disclosed for use with the positioning system, wherein the deflectable catheter and the sheath cooperate so as to facilitate positioning of the ablation member at the location.