This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: Magnetic Resonance guided Focused Ultrasound Surgery System (MRgFUS), ExAblate Model 2000/2100
PMA Applicant: InSightec Ltd.
Address: 5 Nahum Heth St. Tirat-Carmel, 39120, Israel
U.S. Representative: InSightec, Inc., 4851 LBJ Freeway, Suite 400,
Dallas, TX 75244
Approval Date: October 18, 2012
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf11/p110039a.pdf
What is it? The ExAblate is a Magnetic Resonance guided Focused Ultrasound Surgery (MRgFUS) device that non-invasively targets and destroys tissues. This imaging device is intended for pain palliation of metastatic bone cancer in patients for whom radiation therapy is not an alternative. Treatment typically lasts up to 3 hours.
How does it work? The ExAblate combines two technologies:
- a focused ultrasound beam that heats and destroys the outer membrane of the bone that contains the pain-causing nerves, using high-frequency, high-energy sound waves; and
- a Magnetic Resonance Imaging (MRI) and thermal mapping system to allow planning of the treatment with real time temperature and anatomical monitoring.
When is it used? The ExAblate is intended for use in patients who:
- are suffering from symptoms of bone cancer (metastases) and for whom radiation therapy is not an alternative.
- have a bone tumor to be treated that is visible on non-contrast MRI and is enhanced on contrast MRI.
- have the target tumor device-accessible (that is, located so the tumor could be accessed without being shielded by other bones).
What will it accomplish? The ExAblate is used to treat patients who are suffering from symptoms of bone metastases and are radiation-failure patients. The device may help to reduce a patient’s worst pain and may improve or stabilize a patient’s quality of life for a duration of at least 3 months.
When should it not be used? The ExAblate treatment is contraindicated for use in:
- patients with standard contraindications for MRI including non-MRI compatible implanted metal devices (such as cardiac pacemakers), size limitations, weight greater than 242 pounds, allergies to MRI contrast agent(s), etc.
- patients who need pre-treatment surgical stabilization of the affected bony structure. The targeted tumor is in an impending fracture, or has been stabilized with metallic implants.
- women who are pregnant.
- patients with extensive scarring in an area in the path of the energy-planned passage to the treatment area.
- patients whose clinicians are unable to avoid important structures (such as a scar, skin fold or irregularity; bowel, other bone, surgical clips, or any hard implants) in the path of the ultrasound beam.
The Summary of Safety and Effectiveness Data and labeling are available.