FDA Clears Accessory for Uterine Fibroid Treatment System

Uterine Fibroid specialist company, Halt Medical has announced that the U.S. FDA has granted 510(k) clearance for the Acessa Guidance Hand Piece, an accessory for the treatment of symptomatic uterine fibroids.

Background

Halt Medical professes to be focused on innovating in medical devices to establish a new standard of care for women with symptomatic uterine fibroids. Its Acessa Procedure involves a minimally invasive laparoscopic approach to delivering radiofrequency energy to destroy the fibroids. After treatment, the destroyed fibroid is re-absorbed by the surrounding tissue.

Halt says Acessa allows the surgeon to treat only the fibroids, while preserving normal function of the uterus. With the Acessa Procedure, there are no uterine incisions, no tissue removal or extraction, and no power morcellation — everything is contained within the uterus. Patients typically go home the same day with little pain, and enjoy a rapid return to normal activities.

The Acessa System is indicated for the treatment of symptomatic uterine fibroids and is available at leading medical centers throughout the U.S., says the company.

Company comments

“The FDA’s clearance of this advanced technology is another step forward for Halt Medical in the development of safe, minimally invasive procedures for the treatment of symptomatic uterine fibroids. The Acessa Procedure provides women with an attractive uterine-sparing fibroid treatment alternative,” said Jeffrey M. Cohen, Chief Executive Officer of Halt Medical.

Source: Halt Medical, Inc., PR Newswire

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