Abstract: Apparatus and methods for determining positioning of a energy delivery element include deploying a energy delivery element at a treatment site proximal to a vessel wall; using a multi-region pressure sensing apparatus to sense pressures applied in a plurality of directions about the energy delivery element; and determining an orientation of the energy delivery element based on the pressures measured in the plurality of directions about the energy delivery element.

Abstract: A compressible and expandable stent assembly for implantation in a body lumen such as a mitral valve, the stent assembly including at least one stent barrel that is shaped and sized so that it allows for normal operation of adjacent heart structures. One or more stent barrels can be included in the stent assembly, where one or more of the stent barrels can include a cylinder with a tapered edge.

Abstract: An introducer for a medical lead, the introducer having an arcuate component for creating an arcuate path in a patient. When used to percutaneously implant a medical device such as a medical lead with electrodes, the implanted lead has an arcuate configuration. The implanted lead can be used to at least partially encircle or bracket a region of chronic pain and provide therapeutic electrical signals to the region.

Abstract: A pump drive for an extracorporeal blood pumping system including an adjustable drive magnet. The pump drive may be coupled to a blood pump which includes a pump impeller. The pump drive may include a stepper motor for dynamically adjusting the position of the drive magnet. The position of the drive magnet may be varied to vary the distance between the drive magnet and an impeller magnet of the pump impeller. Adjusting the position of the drive magnet may include dynamically adjusting the drive magnet and may include axially moving the drive magnet to thereby vary a magnetic attraction force between the drive magnet and the impeller magnet which may thereby minimize forces acting on one or more bearings of a pump impeller.

Abstract: A method of dimensionally stabilizing a lumen of a multi-lumen device during manufacture wherein one or more minor lumens may contain a fluid that maintains patency of the one or more minor lumens without the need for a solid core within. The at least one second lumen tube may be in fluid communication with a fluid source during the manufacturing process, such as during extrusion and/or mesh overlay steps. Preventing collapse of the one or more minor lumens during manufacture using a fluid instead of a solid core allows the lumens to have any of a variety of shapes and configurations that would be difficult, cost prohibitive, or impossible for a solid core to be used. Also, obviating the need for a solid core within one or more lumens reduces cost and production complexity. The fluid may be a non-compressible liquid or a pressurized gas.

Abstract: A system and method for a procedure that can be performed on any appropriate subject. Procedures can include assembling any appropriate work piece or installing members into a work piece, such as an airframe, autoframe, etc. Regardless of the subject, generally the procedure can have a selected result that is efficacious. The efficacious result may be the desired or best result for the procedure. The system and method can be used in confirming a selected result that can be efficacious.

Abstract: An implantable prosthesis for percutaneous placement within a vein that forces opposing portions of the vessel wall of a vein together to create a new valve of autologous vein tissue to be operable to alternate between a valve closed configuration and a valve open configuration. When in a preset closed configuration, the implantable prosthesis pushes or pulls portions of the vessel wall of the vein together to substantially close the vein lumen and prevent retrograde blood flow from backflowing through the new valve in the valve closed configuration. The implantable prosthesis has leg portions that may be pushed apart in response to antegrade blood flow through the vein to allow the new valve to achieve the valve open configuration.

Abstract: A medical method, device, and system are provided, including advancing an ablation element of a medical device into contact with tissue to be treated, selecting a power level of energy to ablate the tissue, delivering energy at the selected power level to the ablation element, determining whether the ablation element is in continuous contact with the tissue, and reducing the selected power level when the ablation element ceases to be in continuous contact with the tissue.

Abstract: A heart valve prosthesis is provided having a self-expanding multi-level frame that supports a valve body comprising a skirt and plurality of coapting leaflets. The frame transitions between a contracted delivery configuration that enables percutaneous transluminal delivery, and an expanded deployed configuration having an asymmetric hourglass shape. The valve body skirt and leaflets are constructed so that the center of coaptation may be selected to reduce horizontal forces applied to the commissures of the valve, and to efficiently distribute and transmit forces along the leaflets and to the frame. Alternatively, the valve body may be used as a surgically implantable replacement valve prosthesis.

Abstract: Disclosed is a surgical navigation system for tracking an instrument relative to a patient. The system can track a portion of the patient, an instrument, and/or both relative to image data, a coordinate system, an atlas, a morphed atlas, or combinations thereof. The system can include a tracking device on the instrument to provide six degree of freedom information regarding the location of the instrument.

Abstract: System and method for implanting an implantable medical device. A catheter has a lumen and a distal portion configured for insertion in proximity of tissue of a patient. An implantable medical device has a fixation member operatively coupled to the housing having an unengaged state when in the lumen of the catheter and an engaged state configured to engage tissue of a patient when outside of the lumen of the catheter, the medical device being magnetically attractable. A magnetic element is configured to magnetically engage the implantable medical device and to pass through the lumen of the catheter.

Abstract: A delivery device for a stented heart valve that includes a handle, an inner catheter shaft extending from the handle and having an enlarged bumper element at a distal end, an outer catheter shaft extending from the handle and slidably coupled around the inner catheter shaft, and a retraction mechanism for controlling longitudinal movement of the outer catheter shaft relative to the inner catheter shaft. The outer catheter shaft includes a generally cylindrical housing at a distal end that is structured to receive the bumper element therein.

Abstract: Implantable medical devices (IMD) configured for implantation within a recess formed in a cranium of a patient, as well as associated methods, are described. In some embodiments, the IMD includes a top external surface and another adjacent external surface, e.g., a side surface, which are oriented with respect to each other to define an acute angle. A connection module for an electrical lead or catheter may be included on the top external surface. Embodiments of the invention may facilitate implantation of an IMD within a recess formed in the cranium of a patient at a location remote to an incision made in the scalp of the patient.

Abstract: A replacement prosthetic heart valve for engagement with a structure of a previously implanted prosthetic heart valve. The replacement heart valve includes a stent structure including a generally tubular body portion with an interior area and a series of wire portions arranged in a mesh-like configuration, and at least one stent post engaging structure extending radially outwardly from the body portion for engaging with an outer surface of a stent post of the previously implanted prosthetic heart valve. The stent structure further includes at least two leaflets attached within the interior area of the tubular body portion of the stent structure.

Abstract: Devices, systems, and methods for immobilizing an implanted catheter tip while a catheter stylet is withdrawn from the catheter. In one embodiment, a cannula system is included that incorporates a catheter retainer securable to an immobilized guide cannula. The retainer may include one or more surfaces that operatively engage the catheter and effectively restrain the catheter relative to a head of the guide cannula. Other embodiments may also include a stylet holder operable to engage the stylet with a consistent and repeatable clamping force that is independent of clinician-applied force.

Abstract: In one example, a method includes selecting, by one or more processors and based on a representation of sensed electrical signals for a particular patient and a plurality of representations of sensed electrical signals for a plurality of other patients, a combination of electrodes of a plurality of combinations of one or more implantable electrodes for delivery of electrical stimulation to the particular patient.

Abstract: A prosthetic valve including a replacement valve having a tubular valve body wall, an expandable stent having a framework with first and second ends, and suturing holding the framework to the valve body at the first and second ends. The suturing at the first end is colored differently from the suturing at the second end.

Abstract: An implantable medical device (IMD) and methods of fabricating the same are provided. An IMD can include a housing and a cofire ceramic module (CCM) coupled to the housing. The CCM can include an antenna cofire-integrated in the CCM. The antenna can include a plate composed of conductive material, and conductive antenna elements that are annular substrates having perimeters substantially coextensive with the perimeter of the plate. The antenna can also include interconnections. A first set of interconnections can be coupled between the plate and one of the conductive antenna elements, and a second set of interconnections can be coupled between the conductive antenna elements. The antenna can also include a feed line conductively coupled to the plate. In some embodiments, the feed line can be substantially serpentine-shaped to adjust impedance in the CCM.

Abstract: A medical device system and method for determining pacing threshold data that includes a cardiac capture sensor, a phrenic nerve stimulation sensor, a pulse generator selectively coupled to a plurality of electrode vectors to deliver a pacing stimulation pulse, and a processor coupled to the cardiac capture sensor, the phrenic nerve stimulation sensor and the pulse generator and configured to deliver the pacing simulation pulse along the plurality of electrode vectors, determine, for each vector of the plurality of vectors, a pacing capture threshold in response to the delivered pacing pulse, deliver a phrenic nerve stimulation pulse along only the vectors of the plurality of vectors that the determined pacing capture threshold is less than a predetermined pacing capture threshold limit, and determine whether phrenic nerve stimulation is detected in response to the delivered phrenic nerve stimulation pulse.

Abstract: Peripheral nerve field stimulation (PNFS) delivered by medical device to a patient may be programmed by specifying one or more characteristics of a stimulation field generated by the IMD to provide the PNFS. The characteristics of the stimulation field may include, for example, a direction of stimulation within the field, a breadth of the stimulation field, a focus of stimulation within the stimulation field, a depth of the stimulation field relative to a reference point, such as the epidermis of the patient, or a nerve fiber diameter selection.