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New Device Approval

ExAblate® 2000 System - P040003

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 and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.

Product Name: ExAblate® 2000 System
Applicant: InSightec
Address:
InSightec, Ltd.
7 Etgar St. Einstein Bldg.
New Industrial Zone
Tirat-Carmel 39120, Israel

US Representative
InSightec, Inc
2777 Stemmons Freeway, Suite 940
Dallas, Tx 75207-2273
Approval Date: October 22, 2004
Approval Letter: http://www.fda.gov/cdrh/pdf4/P040003a.pdf

What is it? ExAblate® 2000 is a new medical device that uses magnetic resonance image guided focused ultrasound to target and destroy uterine fibroids, non-cancerous masses located in the uterus. The device is intended to treat women who have completed child bearing or do not intend to become pregnant. ExAblate® 2000 is non-invasive surgery. It spares the uterus and is an alternative to myomectomy, hysterectomy, watchful waiting, hormone therapy, or uterine fibroid embolization. Treatment typically lasts about three hours.

How does it work? ExAblate® 2000 combines two systems:
(1) a focused ultrasound beam that heats and destroys the uterine fibroid tissue using high-frequency, high-energy sound waves; and
(2) a magnetic resonance imaging (MRI) and thermal mapping system to visualize patient anatomy, map the volume of fibroid tissue to be treated, and monitor the temperature of the uterine tissue after heating.

This is the first time these two systems have been combined and the first time MRI has been used to monitor tissue temperature.

When is it used? The ExAblate® 2000 is intended for use in women who:

• have symptomatic uterine fibroids;
• are pre- or peri-menopausal;
• desire a uterine sparing treatment;
• have a uterine volume of less than 24 weeks; and
• have completed child bearing.

What will it accomplish? ExAblate® 2000 is a non-invasive surgical treatment that spares the uterus. It is used to treat patients with symptomatic fibroids who desire a decrease in symptoms caused by uterine fibroids.

When should it not be used? The ExAblate® 2000 treatment is contraindicated for use in women who have:

• MRI related issues, such as metallic implants, or sensitivity to MRI contrast agents;
• obstructions in the treatment beam path, such as a scar, skin fold or irregularity, bowel, pubic bone, IUD (intrauterine device), surgical slips, or any hard implants; and
• fibroids that are close to sensitive organs such as the bowel or bladder, or are outside the image area.

Additional information: Summary of Safety and Effectiveness and labeling will be available at: http://www.fda.gov/cdrh/pdf4/p040003.html

Other:

• FDA Talk Paper:
  http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01319.html
• Information on Uterine Fibroids:
  http://www.nlm.nih.gov/medlineplus/uterinefibroids.html
• Uterine Anatomy:
  http://www.nuff.org/health_theuterus.htm

Updated November 3, 2004

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