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Halt to expand launch of laparoscopic technology

Source:Halt Medical, Inc. Release Date:2013-04-02 219
Medical Equipment
Expanded launch of Acessa System for uterine fibroids after clinical trial sites purchase and perform minimally invasive laparoscopic procedures

LIVERMORE, California – Medical device company Halt Medical, Inc. announced initial commercialization results for the Acessa System and additional launch plans.

The Acessa System is a minimally invasive laparoscopic procedure that delivers radiofrequency energy to destroy the fibroids. After treatment, the fibroid is re-absorbed by the surrounding tissue. Acessa allows the surgeon to treat only the fibroids, while preserving normal function of the uterus. Patients typically go home the same day with little pain, and enjoy a rapid return to normal activities. Nearly 300 women have been successfully treated with Acessa.

"We are grateful and encouraged that virtually all our clinical trial sites expressed an interest in launching the Acessa procedure. As of this past week, all four of our initial launch sites have purchased and performed procedures," said Jeffrey M. Cohen, Halt Medical CEO.

The Acessa System was launched initially in the United States with the following physicians: Jay M. Berman , M.D., DMC Sinai-Grace Hospital, Detroit, Michigan; Scott G. Chudnoff , M.D., M.S., Montefiore Medical Center, New York, New York; Richard S. Guido , M.D., Magee-Womens Hospital of UPMC, Pittsburgh, Pennsylvania; and David J. Levine , M.D., Mercy Hospital, Saint Louis, Missouri.

"The economic challenges to launching new technology in today's healthcare environment are daunting," said Rodney Marcy, Halt's senior vice president of Sales and Marketing.  "Despite those challenges, our backlog of physicians and facilities desiring to integrate Acessa in to their procedural offering for the treatment of fibroids continues to grow. Current plans have us opening an additional five cities in April."

The results of both U.S. and international trials of Acessa 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.

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