Under the new labeling, the agency allows physicians to treat up to 100% of the fibroid compared to its previous restriction to only treat up to half the fibroid tissue.
According to InSightec, the FDA label change was based on a growing body of evidence supporting the system’s safety and efficacy, including the results of a study demonstrating that patients experience longer and improved symptom reduction as a greater volume of the fibroid is destroyed.
Kobi Vortman, president and CEO of InSightec, said: “We’re extremely pleased that the FDA approved this important label change and believe this underscores the safety of our system, the only non-invasive treatment for uterine fibroids available today. We remain committed to continuously expanding our treatment indications and applications through research.”