A device and method for ablating tissue is disclosed comprising the steps of acquiring an anatomical image of a patient, correlating the image to the patient, guiding an ablating member within the patient while tracking the position of the ablating member in the patient, positioning the ablating member in a desired position to ablate tissue, emitting ablating energy from the ablating member to form an ablated tissue area and removing the ablating member from the patient.

Methods of using high intensity focused ultrasound to form an ablated tissue area containing a plurality of lesions

This PMA supplement was submitted to gain approval for the following changes to the St Jude Medical's Durata family of defibrillation leads: suture sleeve design change, introduction of new suture sleeve accessory kit for redesigned suture sleeve, reduction in FastPass coating length, and design modification to IS-1 crimp connection. Initially, FDA presented 7 major and 3 minor deficiency concerns in a letter dated July 30, 2010. The firm responded to those concerns in P950022/S069/A001.

Food and Drug Administration Center for Devices and Radiological Health

System, devices and methods are presented that integrate stretchable or flexible circuitry, including arrays of active devices for enhanced sensing, diagnostic, and therapeutic capabilities. The invention enables conformal sensing contact with tissues of interest, such as the inner wall of a lumen, a the brain, or the surface of the heart. Such direct, conformal contact increases accuracy of measurement and delivery of therapy. Further, the invention enables the incorporation of both sensing and therapeutic devices on the same substrate allowing for faster treatment of diseased tissue and fewer devices to perform the same procedure.

Systems,methods, and devices having stretchable integrated circuitry for sensing and delivering therapy

Methods and apparatus are provided for bilateral renal neuromodulation, e.g., via a pulsed electric field, via a stimulation electric field, via localized drug delivery, via high frequency ultrasound, via thermal techniques, etc. Such neuromodulation may effectuate irreversible electroporation or electrofusion, necrosis and/or inducement of apoptosis, alteration of gene expression, action potential attenuation or blockade, changes in cytokine up-regulation and other conditions in target neural fibers. In some embodiments, neuromodulation is applied to neural fibers that contribute to renal function. In some embodiments, such neuromodulation is performed in a bilateral fashion. Bilateral renal neuromodulation may provide enhanced therapeutic effect in some patients as compared to renal neuromodulation performed unilaterally, i.e., as compared to renal neuromodulation performed on neural tissue innervating a single kidney.

Methods and apparatus for bilateral renal neuromodulation

Methods and apparatus are provided for thermally-induced renal neuromodulation. Thermally-induced renal neuromodulation may be achieved via direct and/or via indirect application of thermal energy to heat or cool neural fibers that contribute to renal function, or of vascular structures that feed or perfuse the neural fibers. In some embodiments, parameters of the neural fibers, of non-target tissue, or of the thermal energy delivery element, may be monitored via one or more sensors for controlling the thermally-induced neuromodulation. In some embodiments, protective elements may be provided to reduce a degree of thermal damage induced in the non-target tissues.

Ultrasound apparatuses for thermally-induced renal neuromodulation

An inflatable cuff having integrated ultrasound transducers is used to effect hemostasis of deep bleeding wounds in limbs. The cuff includes a chamber defined by a bladder or a series of dams into which a fluid may be introduced and pressurized. The pressure of the fluid stops or slows bleeding while high intensity focused ultrasound is applied to effect hemostasis. The fluid may also serve as an acoustic couplant between the limb and the ultrasound transducers. The transducers may be electrostrictive transducers. Diodes may be used to reduce parallel capacitive loading in the transducer array. Bypass capacitors using the electrostrictive material may also be used.

Systems and methods for performing acoustic hemostasis of deep bleeding trauma in limbs

Therapy control and/or monitoring is performed with an ultrasound scanner. The ultrasound scanner detects temperature to monitor therapy, and perform HIFU beam location refocusing of the therapy system based on the temperature. The monitoring is synchronized with the therapy using a trigger output of the ultrasound scanner. The trigger output responds to a scan sequence of the ultrasound scanner. To meet a given therapy plan, the scan sequence is customized, resulting in the customized trigger sequence. Three dimensional or multi-planar reconstruction rendering is used to represent temperature for monitoring feedback. The temperature at locations not being treated may be monitored. If the temperature has an undesired characteristic (e.g., too high), then the therapy is controlled by ceasing, at least temporarily.

Ultrasound for Therapy Control or Monitoring

A targeting catheter is used to locate an arteriotomy, such as is formed during a femoral artery catheterization procedure. The targeting catheter includes one or more targeting aids, such as an inflatable balloon or sensor (e.g., Doppler or temperature sensor), to locate the arteriotomy. The targeting aid may be positioned at the arteriotomy. An ultrasonic beacon on the catheter may then be located relative to a therapeutic ultrasonic applicator (e.g., by using acoustic time-of-flight) so that the focus of ultrasonic energy from the applicator can be aligned with the arteriotomy.

Systems and methods for arteriotomy localization

Therapeutic ultrasound applicator is provided for use with magnetic resonance system. An array of many elements, such as a multi-dimensional array, is used. To avoid cabling, the transmitters are positioned at the array. The array and transmitters are shielded to reduce interference. To avoid large inductors for the many elements, an acoustic matching layer may be sized to provide a desired phase angle or electrical impedance matching.

Therapeutic Ultrasound for Use with Magnetic Resonance

Electrostrictor material is used as transducer elements in an ultrasonic array comprising bias and signal dimensions. The bias dimension is used for Fresnel focusing and the signal dimension is used for beam forming. Positive and negative polarity may used along the bias dimension. In some cases, a zero bias is also used within the Fresnel aperture. Dynamic switching of the bias and signal dimensions may also be employed.

Therapeutic and diagnostic electrostrictor ultrasonic arrays

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