Halt Medical Announces FDA Clearance of the Acessa Guidance Hand Piece for Treatment of Symptomatic Uterine Fibroids
LIVERMORE, Calif., May 9, 2014 /PRNewswire/ -- Halt Medical, a medical device innovator focused on establishing a new standard of care for women with symptomatic uterine fibroids, today announced that on April 28, 2014 the Food and Drug Administration (FDA) granted 510(k) clearance for the Acessa Guidance Hand Piece, an accessory for the treatment of symptomatic uterine fibroids.
"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.
The Acessa Procedure is a minimally invasive laparoscopic procedure that delivers radiofrequency energy to destroy the fibroids. After treatment, the destroyed fibroid is re-absorbed by the surrounding tissue. 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 FDA-cleared for the treatment of symptomatic uterine fibroids and is now available at leading medical centers throughout the U.S.
About Halt Medical, Inc.
Founded in 2004, Halt Medical is a medical device innovator focused on establishing a new standard of care for women with symptomatic uterine fibroids. The Company has developed and launched the Acessa System and Procedure, using radiofrequency energy to destroy uterine fibroids. The results of both U.S. and international trials have led to the clearance of the product by the FDA for use in percutaneous, laparoscopic coagulation and ablation of soft tissue, including treatment of symptomatic uterine fibroids under laparoscopic ultrasound guidance. The Acessa System also has regulatory approval to treat symptomatic uterine fibroids in the European Union, Canada, and Mexico. The Company is located in Brentwood, CA. For information about the Acessa System, please visit www.haltmedical.com.
SOURCE Halt Medical, Inc.