Breakthrough in Uterine Fibroid Treatment with ExAblate 2000 System

The 90th Scientific Assembly and Annual Meeting of the Radiological Society of North America (RSNA) featured InSightec's ExAblate 2000 Magnetic Resonance-guided Focused Ultrasound (MRgFUS) system, which offers a non-invasive treatment for uterine fibroids. The system combines MRI with high-intensity focused ultrasound to ablate tissue without incisions. On October 22, 2004, the U.S. Food and Drug Administration (FDA) approved the ExAblate 2000 System for the treatment of uterine fibroids, citing its significant advantages over existing treatments.

Key Takeaways:

  • The ExAblate 2000 System is a non-invasive treatment for uterine fibroids, combining MRI with high-intensity focused ultrasound to ablate tissue.
  • In a multi-national trial with 109 women, 70.6% reported significant improvement in fibroid-related symptoms after 6 months of treatment.
  • Patients treated with ExAblate missed an average of 1.4 working days within 30 days after treatment, compared to 18 days for total abdominal hysterectomy patients.
  • ExAblate patients returned to normal activity in less than 3 days, compared to 17 days for hysterectomy patients.
  • The system is only compatible with General Electric Healthcare's SIGNA 1.5 Tesla Magnetic Resonance systems.
  • 8 major medical centers in the United States are equipped with the ExAblate 2000 System, with installations also in London, Berlin, Tel Aviv, and several locations in Japan.
  • InSightec is conducting clinical trials for breast fibroadenomas, breast cancer, bone, liver, and brain tumors, as well as additional studies with uterine fibroids.

Statistics:

  • 70.6% of women with symptomatic uterine fibroids reported significant improvement in fibroid-related symptoms after 6 months of ExAblate treatment.
  • Average number of working days missed by patients treated with ExAblate: 1.4 days.
  • Average number of working days missed by patients treated with total abdominal hysterectomy: 18 days.
  • Time to return to normal activity for ExAblate patients: less than 3 days.
  • Time to return to normal activity for total abdominal hysterectomy patients: 17 days.
  • Number of major medical centers equipped with the ExAblate 2000 System in the United States: 8.

Sources:

  • NewsRx.com & NewsRx.net
  • NewsRx (2004 DEC 27)
  • U.S. Food and Drug Administration (FDA)
  • InSightec Image Guided Treatment Ltd.
  • General Electric Healthcare
  • Radiological Society of North America (RSNA)