ExAblate OR Brochure for outside USA
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The Operating Room of the Future. Image guided Robotic Acoustic Surgery using MR guided Focused Ultrasound technology ExAblate Oft is a non-invasive Operating Room: □ Non-invasive outpatient procedure □ Real-time treatment outcome monitoring and control Z] Minimizes complications, adverse events and recovery time □ High treatment conformity, sparing non-targeted tissue □ Single platform for multiple indications □ Single session treatment

Personalized surgery for optimal results The ExAblate OR system integrates two well established technologies, focused ultrasound and magnetic resonance imaging, to non-invasively ablate targeted tissue within the body while sparing the surrounding tissue. Healthcare providers can now offer their patients personalized surgery with ExAblate OR to achieve optimal treatment results in an outpatient procedure. The system uses multi-parametric MR imaging for: •• Tumor visualization and imaging in three orientations to provide precise and accurate identification of pathology •• Treatment planning...

ExAblate features Complete control over treatment The physician controls the treatment from the operator console. Adjustments are made during treatment based on treatment outcome monitoring, patient comfort and patient movement. Treatment time varies according to the indication being treated and the volume of the tumor. Planning Treatment Beam shaping Evaluation Elongated Short Pre-treatment 3D multiparametric imaging enables precise tumor targeting Real-time feedback and beam path visualization for controlled treatment Nominal Ability to shape the beam to overcome obstacles and for greater...

Pain management Caution – Investigational Device Limited by United States Law to Investigational Use. CE approved for bone tumors Bone Metastases ExAblate may provide non-ionizing, localized pain relief by thermally ablating the nerves on the periosteum. Each sonication is capable of ablating a large area along the bone surface. Since the thermal conduction of the bone is relatively low, the focused ultrasound beam affects mainly the area on the bone that is covered by the beam. During a bone treatment, the system is configured so that the targeted bone will be heated in a uniform way....

Bone Metastases Case review A Female patient with primary breast cancer Osteoblastic bone lesion in the left illiac bone Courtesy of LATO-S. Raffaele Giglio Hospital, Cefalù, Italy CT image Axial T2w planning image Post-treatment contrast enhanced images showing non-enhanced area of the targeted bone, surrounded by soft tissue edema Post-treatment contrast enhanced subtraction images showing nonenhanced area of the targeted bone, surrounded by soft tissue edema Case review B 52 year old patient with primary breast cancer Courtesy of Bundang CHA Hospital, Korea CT image of targeted bone...

Prostate cancer Caution – Investigational Device Limited by United States Law to Investigational Use. ExAblate is being investigated for the treatment of early stage, low risk prostate cancer. The ExAblate OR prostate module is an endorectal device designed for non-invasive thermal ablation of prostate tumors using high intensity focused ultrasound under real-time MR imaging monitoring and control. Current treatment options for prostate cancer include prostatectomy (surgical removal of the prostate gland), radiation therapy, brachytherapy (implantation of radioactive seeds), and...

Liver cancer Caution – Will require FDA investigational device exemption ExAblate is being investigated (outside of the USA) for the treatment of liver tumors. This is a prevalent disease with limited treatments available. Surgical resection is an option for only a small percent of patients and local ablative techniques such as microwave, laser, cryotherapy and radiofrequency ablation treat another relatively small group of patients and require penetration of the liver capsule which may cause adverse events. Because ExAblate delivers thermal energy to a precisely defined tumor deep in the...

Breast cancer Caution – Investigational Device Limited by United States Law to Investigational Use. The ExAblate OR breast module is being investigated (outside of the USA) and is currently under FDA investigational review for the treatment of breast cancer. The desired result is total non-invasive ablation of the tumor verified by MR images. ExAblate may offer the following potential benefits: Tumor •• Non-invasive alternative to surgical lumpectomy Water Bath •• Definition of tumor boundaries by multi-parametric MR imaging •• No general anesthesia, surgery, surgical scar, or need for...

Uterine fibroids Approved for commercial use ExAblate® OR treats symptomatic uterine fibroids. This outpatient treatment provides ablation of fibroids and offers sustained symptom relief. The system enables precise treatment monitoring; outcomes can be predicted immediately after completion of the procedure. More than six thousand women worldwide have opted for the ExAblate non-invasive treatment for uterine fibroids and the numbers keep growing. ExAblate expands treatment choices for women, offering: Fibroid •• Uterus sparing procedure •• Consistent, predictable and immediate results ••...

References 1. Al Hilli MM, Stewart EA. Magnetic Resonance-Guided Focused Ultrasound Surgery, Seminars in Reproductive Medicine, 2010, 28(3):242-249 2. Catane R, Beck A, Inbar Y, Rabin T, Shabshin N, Hengst S, Pfeffer RM, Hanannel A, Dogadkin O, Liberman B, Kopelman D. MR-guided Focused Ultrasound Surgery (MRgFUS) for the Palliation of Pain in Patients with Bone Metastases – Preliminary Clinical Experience, Annals of Oncology, 2006. 3. Liberman B, Gianfelice D, Inbar Y, Beck A, Rabin T, Shabshin N, Chander G, Hengst S, Pfeffer R, Chechick A, Hanannel A, Dogadkin O, Catane R. Pain Palliation...

Excellence Backed by Experience InSightec® is the pioneer and global leader in MR guided focused ultrasound technology for image guided acoustic surgery. ExAblate® 2000 system was the first system to use the MR guided focused ultrasound technology. The ExAblate 2000 system received CE mark in 2002 and the Food and Drug Administration (FDA) approval in 2004 for the treatment of symptomatic uterine fibroids. ExAblate 2000 received the European CE Mark for pain palliation of bone metastases in June 2007 and for adenomyosis in June 2010. This device has won numerous innovation awards and has...