Halt Medical recently received clearance from the United States Food and Drug administration for its Accessa device. The Accessa device is used by gynecologists to treat uterine fibroids in females.
The Brewood, California-based company made the announcement on Tuesday. As of now, the Acessa device has been approved in Canada and has received CE Mark approval from the European Union.
In a prepared statement, president Jeffrey Cohen stated, “The high patient satisfaction and low re-intervention rates seen in our clinical studies provides the opportunity for the healthcare system to replace radical surgery and save billions of dollars.”
The new treatment technology from Halt Medical has several advantages over similar medical devices. In a traditional fibroid surgery, a surgeon has to cut through several layers of healthy, viable tissue to reach a tumor. In some cases, traditional surgical techniques require the complete removal of the uterus. The new device from Halt Medical uses RF ablation to directly target the site of a tumor. This minimizes damage to the healthy tissue surrounding a malignant tumor.
According to to data from the American Journal of Obstetrics and Gynecology, the market for uterine fibroid treatment programs is an estimated $6 billion to $35 billion every year. Unlike other treatment methods, Halt Medical’s Acessa will allow surgeons to provide outpatient surgery for this debilitating health issue.