FDA allows MRI-guided breast tumor ablation trials

The FDA has approved phase III clinical testing of a new breast cancer treatment system based on high-frequency ultrasound (HIFUS) tumor ablation, performed under MRI guidance. The system, called ExAblate, was developed by InSightec of Tirat Carmel, Israel.

InSightec initially developed the noninvasive system for the treatment of tumors in the stomach and chest cavities. Phase III clinical testing for the treatment of breast tumors (fibroadenomas) will begin shortly at medical centers in the U.S. and Canada. Israel has approved clinical testing at two medical centers in that country.

Phase II testing of the product for the treatment of uterine fibroids is underway in the U.S. and Europe, with phase III clinical tests slated for early 2002.

Elbit Medical Imaging of Haifa, Israel holds a 75% interest in InSightec, which was established in 1999 as a joint venture between Elbit and GE Medical Systems of Waukesha, WI.

By AuntMinnie.com staff writers
October 29, 2001