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The Thera Vision Ultrasound Ablation System, ACOUSTx Applicators, and accessories are intended for the laparoscopic, intraoperative, and percutaneous coagulation and ablation of soft tissue. It is not indicated for ablation of prostate tissue.

The TheraVision System consists of the following subsystems: - 4.1 Computer System: The computer system consists of a PC Compatible type computer running Microsoft Windows® Operating system. - 4.2 Visualization Options: Visualization options include utilization with compatible, legally marketed imaging systems. Patient images may be imported in DICOM format from MRI, CT, US, Fluoroscopic X-Ray, and PET-CT scanners. - 4.3 Software: A set of user interface and display modules allow user interaction and high-level control over the system, including power generation and safety monitoring. Top-level modules provide top level menu options and implement next-generation Microsoft Windows® display functionality. - 4.4 Thermometry System: Temperature monitoring is accomplished using an optional multichannel type T patient isolated thermocouple data acquisition system. - 4.5 RF Generation System: A Multichannel RF power generator system provides the RF enerqy needed drive the piezoelectric transducers for generation of sufficient ultrasound acoustic energy from the applicators to raise the temperature to therapeutic levels in the targeted tissue - 4.6 Cooling System: Degassed sterile water is pumped through the ultrasound transducers in the applicators and provides ultrasound energy coupling to tissue and also provides a means for cooling the applicator. ACOUSTx Applicators: The ultrasound energy generated from ACOUSTx Applicators is absorbed during treatment producing thermal therapy within the targeted tissue region. The ACOUSTx Applicators are sterile and single-use and can be utilized with the TheraVision System and may contain up to four transducers each with angular insonation patterns of 360° or 180° for application of thermal therapy.

The Sonatherm is indicated for the laparoscopic or intraoperative ablation of soft tissue from the ultrasound focal zone back to the surface of the targeted ablation area in General Surgery. The Sonatherm is not to be used for non-invasive ablation, i.e. leaving intervening tissue spared, and it is not indicated for the ablation of Prostate tissue.

The Sonatherm 600i is a modification of the previously cleared Sonatherm 600 (K 042096). The Sonatherm 600i uses the same HIFU transducer, with the same ultrasonic lesion generating power output as the Sonatherm 600. The Sonatherm 600i operates in the same manner as the Sonatherm 600. The Sonatherm 600i operates by utilizing a focused ultrasound transducer positioned at the surface of the targeted ablation area to create a thermal lesion from the focal point of the transducer back to the surface of the targeted area in an open field or laparoscopic scenario. The Sonatherm 600i incorporates three changes to the Sonatherm 600: a microprocessor controlled LCD user interface; a visually aided focal point targeting system; an integrated transducer positioning device The microprocessor controlled LCD user interface incorporates a graphical interface that makes the operation of the device easier. The integrated positioning device allows the user to verify the positioning of the Sonatherm 600i probe over the intended target volume. This reduces the chance for operator error.

The Ultrazonix Spine Minimal-Invasive Disc System is intended for use by professional medical personnel for coagulation and decompression of intervertebral disc material to treat symptomatic patients with annular disruption of contained herniated lumbar discs. The safety and efficacy of this device has not been established in the thoracic and cervical intervertebral regions of the spine and should not be used in those regions.

The Ultrazonix Spine Minimal-Invasive Disc System is intended for use by professional medical personnel for coagulation and decompression of intervertebral disc material to treat symptomatic patients with annular disruption of contained herniated lumbar discs. The safety and efficacy of this device has not been established in the thoraci and cervical intervertebral regions of the spine and should not be used in those negions. The Ultrazonix Spine Minimal-Invasive Disc System is comprised of a non-disposable Control Unit, and a sterile, single-use Probe Kit. These two major component parts are described as follows: a) Non disposable Control Unit This contains a power supply, a high frequency-generator, an amplifier, an independent safety system and a user interface with an alphanumerical display and a key pad and a foot-operated switch. The probe and a foot-operated switch are connected to the Control Unit. High frequency induced ultrasound is emitted from the probe and controlled by means of the foot-operated switch. b) Sterile, single-use Probe Kit, consisting of A blunt 500 mm long stainless steel Guide Pin with a diameter of 2 mm. The Guide Pin is used as a pathfinder to navigate towards the spinal disk under fluoroscopic guidance. A 5.3 mm Dilator which is used to prepare a canal for the Introducer. It has a conical front which ensures as little harm as possible is done to adjacent tissue and blood vessels A 6 mm Introducer which is a thin walled, approximately 180 mm long tube with a handle to be used as a guide for the Probe. It is placed over the Dilator and when the desired position against the disk is reached the Guide Pin and the Dilator are removed and The ultrasonic Probe is inserted into the Introducer. It consists of a thin shaft with a piezo ceramic transducer placed at the front /tip.

The Sonatherm is indicated for the laparoscopic or intraoperative ablation of soft tissue from the ultrasound focal zone back to the surface of the targeted treatment area in General Surgery.

Sonatherm 600 Ultrasonic Lesion Generating System is comprised of a generator, which feeds a 3 to 5 MHz electrical signal to one or more piezoelectric crystals mounted in a hand-held handpiece; the crystals then vibrate at the same frequency. A Coupling Fluid Recirculation System is provided to provide a temperature stabilized coupling/coolant fluid surrounding the Transducer crystal(s). The fluid is contained by a flexible membrane surrounding the transducer head. A user interface provides Input Controls and Output Readouts for Operator. In operation, the Transducer Membrane is placed against the organ to be treated. When the unit is engaged, the transducer will vibrate, create acoustic waves in the coupling fluid that then couples to the organ tissue and propagates into it. The waves converge to a focal point that concentrates the energy within a finite tissue volume. As the temperature of the tissue rises above the ablation point, the tissue necroses. The treatment head is moved under Operator control to treat a preselected volume of tissue from the focal point back to the surface of the organ.

The Epicor Medical UltraCinch is intended for the ablation of cardiac tissue during cardiac surgery. The items in the UltraCinch Accessory Pack are intended for use in the ablation of cardiac tissue during cardiac surgery.

Epicor Medical UltraCinch Tissue Ablation Device and Accessories

The Epicor Medical Ablation System (the UltraWand Ablation Device, Ablation Control System, and Connecting Cable) is Intended for the ablation of cardiac tissue during cardiac surgery.

Epicor Medical Ablation System, including the UltraWand Ablation Device, Ablation Control System, and Connecting Cable