In October 2004, the FDA approved the ExAblate®2000 system for the treatment of uterine fibroids. A requirement of the approval was continued follow-up of a group of patients for 36 months. In December, 2007, InSightec submitted the sixth semi-annual report of results to date. This document is a summary of that report.
Click here to read report.
Summary:
To date over 370 patients have been treated as part of our FDA study. In total, over 2500 patients have been treated worldwide. The results of our analysis indicate that treatment outcomes are reproducible and durable. Furthermore, with the expanded treatment guidelines and greater treatment volumes, there is increased symptom relief and less need for alternative treatment.
Efficacy
The efficacy results show that expanded treatment guidelines (since the original PMA study) have led to a larger percentage of the total fibroid volume being treated per patient. As a result, there is an increase in the improvement of patient symptom severity and the long-term durability of the treatment. The results of the African American study patients, who were treated following the commercial guidelines, show greater efficacy levels, and a significant lower rate of alternative treatments post-MRgFUS treatment.
Safety
The original PMA study showed that MRgFUS is a very safe treatment with significantly lower side effects relative to alternative treatments. It has been shown that even with the expanded volume treated per fibroid the rate of adverse events declined. Since the Pivotal Study, there have been no device or procedure related Serious Adverse Events.
April 8, 2008
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