Devices & Diagnostics

FDA clears ablation treatment that gynecologists can use to treat uterine fibroids in women

Halt Medical, a medical device company based in Brentwood, California, announced Tuesday that the Food and Drug Administration has cleared its Acessa device that gynecologists can use to treat female uterine fibroids. The device uses RF ablation to treat just the fibroids and is an alternative to traditional fibroid surgery where “layers of healthy tissue […]

Halt Medical, a medical device company based in Brentwood, California, announced Tuesday that the Food and Drug Administration has cleared its Acessa device that gynecologists can use to treat female uterine fibroids.

The device uses RF ablation to treat just the fibroids and is an alternative to traditional fibroid surgery where “layers of healthy tissue are cut through to gain access to the tumor or to remove the uterus entirely,” the company said in a news release.

The outpatient procedure has been approved in Europe and Canada previously.

“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,’ said Jeffrey Cohen, Halt Medical’s president, in a statement.

A report published in the American Journal of Obstetrics and Gynecology found that the condition costs anywhere between $6 billion to nearly $35 billion a year.

The National Uterine Fibroids Foundation estimates that on average six weeks of work is lost in recovery times for hysterectomy, a procedure that many women undergo to eliminate the problem of uterine fibroids.

Halt Medical claims that with Acessa, patients can go home the same day, and resume all normal activity in five days or less.

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[Photo Credit: Freedigitalphotos user Surachai]