FDA Approves Upgraded Fibroid System
Broadens Use to Women Preserving Fertility
This month, the US Food and Drug Administration (FDA) broadened treatment options available to the millions of women who suffer from uterine fibroids. First, the FDA approved a more advanced next generation ExAblate system for fibroids. In addition, the FDA removed the “family complete” requirement, confirming that women who want to maintain their fertility can use FUS to treat their fibroids.
“The new version of the ExAblate system gives physicians greater control and more flexibility in treating fibroids with a clearer 3D view of the ongoing procedure,” said Alan H. Matsumoto, MD, Radiology Chairman at the University of Virginia. “With this new technology, treatment time is reduced, allowing for treatment of more fibroid tissue in a given time.”
The loosening of the fertility restrictions is based on clinical data from 118 patient pregnancies after undergoing treatment with ExAblate. “This is a major breakthrough in the treatment of symptomatic uterine fibroids. Gynecologists can now offer patients a treatment that is not only non-invasive and uterus sparing, but with the new labeling, this treatment is also an option for women who are not family complete,” said Haywood Brown, MD, Chairman of Obstetrics and Gynecology at Duke University School of Medicine.
“Many women with fibroids are interested in protecting their fertility, and we are pleased to be able to assure them that focused ultrasound is a safe and effective option to consider prior to conceiving,” said Justine Atkinson, Executive Director of Fibroid Relief.
While the regulatory changes will help with improving the treatment and attracting women, focused ultrasound is still not consistently reimbursed in the US. The Foundation is participating in the design of two new studies to generate long-term data for private payers:
The first in-person stakeholder meeting for COMPARE-UF was held last week in Baltimore. READ MORE >
- COMPARE-UF is a Patient-Centered Outcomes Research Institute (PCORI) registry of fibroid patient decision making and outcomes across a range of common treatments that is being led by Duke University.
- RELIEF is a study comparing outcomes between FUS and myomectomy.