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The Edison System is indicated for the non-invasive destruction of liver tumors, including unresectable liver tumors, using a non-thermal, mechanical process of focused ultrasound.

The HistoSonics Edison System (the "System") provides users with a means to identify, target and destroy liver tumors entirely non-invasively using histotripsy, a non-ionizing, nonthermal, mechanical process of focused ultrasound. Histotripsy is created by delivering high amplitude, very short (microsecond), focused ultrasound pulses designed to induce controlled acoustic cavitation at a known focal location in the form of a "bubble cloud". The bubble cloud is a cluster of microbubbles that form, rapidly expand and collapse, imparting significant stress and strain on soft tissue, including liver tissue. After an adequate number of pulses (less than a few seconds at each bubble cloud location), liver tissue within the bubble cloud is mechanically destroyed, resulting in an acellular lysate with limited to no recognizable cellular structures. Acoustic cavitation (and bubble cloud formation) is only created when there is sufficient negative pressure to exceed the cavitation threshold, making it a threshold phenomenon. The System is comprised of reusable medical equipment and disposable, single-patient use components intended for use in a professional healthcare environment. Reusable portions of the system include the Treatment Cart and a Support Arm and frame that is used to contain ultrasound medium (degassed water) that acoustically couples the system to the patient. Disposable aspects of the system include a clear, acoustically transparent and deformable membrane that holds the ultrasound medium as well as various non-active accessories used during patient set up. The Treatment Cart includes a Treatment Arm/Micropositioning System which is comprised of a six degree of freedom (6 DOF), dual encoded robotic arm. At the end of the arm is the Treatment Head which contains the histotripsy therapy transducer and a coaxially aligned diagnostic ultrasound probe. System software controls the Treatment Arm to direct the bubble cloud through the planned treatment volume. The System is functionally integrated with a GE LOGIQ E10s ultrasound system (K231989), which is provided by HistoSonics with each Edison System.

The Edison System is indicated for the non-invasive destruction of liver tumors, including unresectable liver tumors, using a non-thermal, mechanical process of focused ultrasound.

The HistoSonics Edison System (the "System") provides users with a means to identify, target and destroy liver tumors entirely non-invasively using histotripsy, a non-ionizing, non-thermal, mechanical process of focused ultrasound. Histotripsy is created by delivering high amplitude, very short (microsecond), focused ultrasound pulses designed to induce controlled acoustic cavitation at a known focal location in the form of a "bubble cloud". The bubble cloud is a cluster of microbubbles that form, rapidly expand and collapse, imparting significant stress and strain on soft tissue, including liver tissue. After an adequate number of pulses (less than a few seconds at each bubble cloud location), liver tissue within the bubble cloud is mechanically destroyed, resulting in an acellular lysate with limited to no recognizable cellular structures. Acoustic cavitation (and bubble cloud formation) is only created when there is sufficient negative pressure to exceed the cavitation threshold, making it a threshold phenomenon. The System is comprised of reusable medical equipment and disposable, single-patient use components intended for use in a professional healthcare environment. Reusable portions of the system include the Treatment Cart and a Support Arm and frame that is used to contain ultrasound medium (degassed water) that acoustically couples the system to the patient. Disposable aspects of the system include a clear, acoustically transparent and deformable membrane that holds the ultrasound medium as well as various non-active accessories used during patient set up. The Treatment Cart includes a Treatment Arm/Micropositioning System which is comprised of a six degree of freedom (6 DOF), dual encoded robotic arm. At the end of the arm is the Treatment Head which contains the histotripsy therapy transducer and a coaxially aligned diagnostic ultrasound probe. System software controls the Treatment Arm to direct the bubble cloud through the planned treatment volume. The System is functionally integrated with a GE LOGIQ E10s ultrasound system (K211524), which is provided by HistoSonics with each Edison System.

The Edison System is indicated for the non-invasive destruction of liver tumors, including unresectable liver tumors, using a non-thermal, mechanical process of focused ultrasound.

The HistoSonics Edison™ System (the "System") provides users with a means to identify, target and destroy tissue non-invasively via non-ionizing, non-thermal, mechanical process of focused ultrasound. By delivering high amplitude, very short (microsecond), focused ultrasound pulses the device can induce acoustic cavitation at a known focal location in the form of a "bubble cloud". The bubble cloud is a cluster of microbubbles that form, rapidly expand and rapidly collapse, imparting stress and strain on target soft tissue. After a number of pulses, soft tissue within the bubble cloud is mechanically destroyed, resulting in a homogenous acellular lysate with limited to no recognizable cellular structures. The bubble cloud appears hypoechoic (bright) when viewed on diagnostic (B-mode) ultrasound. Additionally, the bubble cloud is detectable audibly. The System is comprised of reusable medical equipment and disposable, single-patient use components. Reusable portions of the System include the Treatment Cart and a Support Arm and Frame that is used to contain ultrasound medium (degassed water) that acoustically couples the System to the patient. Disposable aspects of the System include a clear, acoustically transparent and deformable membrane that holds the ultrasound medium as well as various non-active accessories used during patient setup. The System is functionally integrated with a GE LOGIQ E10s ultrasound system (K211524), which is provided by HistoSonics with each Edison System. The LOGIO E10s is provided with a preset configuration designed to optimize viewing of the bubble cloud. This configuration falls within the available performance parameters of the LOGIQ E10s covered by K211524. The Treatment Cart is mobile and contains all hardware and software components necessary to localize, plan and deliver treatments. The Treatment Cart includes a large touchscreen user interface and control panel, a high voltage power supply, integrated amplifier circuitry, waveform generator boards, Control PC, and Treatment Arm/Micropositioning System with connected Treatment Head. The System user interface guides the user step by step through the required workflow including Patient Preparation, Localize, Plan and Treat. The treating physician uses the user interface to assess ultrasound images to localize the targeted tissue and define a Planned Treatment Volume (PTV) comprised of a target contour and margin contour. During targeting, the diagnostic ultrasound probe can be extended up to 5 cm in the Z axis to reduce the offset of the ultrasound medium, thereby improving the targeting process versus a non-extended probe. An optional workflow enables the physician to view DICOM images (MRI, CT and PET) adjacent to the live ultrasound to aid the target identification process. Additionally, an image fusion function is an optional workflow that allows physician to fuse the live ultrasound image from the GE LOGIQ E10s onto the previously obtained DICOM images. The Treatment Arm/Micropositioning System is comprised of a six degree of freedom (6 DOF) dual encoded robotic arm and is used to direct the movement of the Treatment Head. The Treatment Arm provides mechanical support to the Treatment Head (containing the Therapy Transducer and the coaxially aligned GE LOGIQ E10s Diagnostic Imaging Probe) and allows gross and fine positioning prior to initiating therapy. The Treatment Head is available in two configurations with different maximum treatment depths to provide physicians with options based on target anatomy. Both Treatment Heads are supplied with the System. Electronic signals from the Treatment Cart are applied to the Therapy Transducer to create a bubble cloud at a known focal point. Note that the bubble cloud location is fixed relative to the position of the Treatment Head. The System uses the software-controlled Micropositioning System to move the Treatment Head, and the resulting bubble cloud, through a programmed treatment pathway to enable treatment delivery at all bubble cloud locations included as part of the PTV.