NEWS

05/06/1996



<TITLE> FDA APPROVES NEW DEVICE TO TREAT ENLARGED PROSTATE

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P96-9                              Food and Drug Administration

FOR IMMEDIATE RELEASE              Sharon Snider (301) 443-3285

May 6, 1996                        







       FDA APPROVES NEW DEVICE TO TREAT ENLARGED PROSTATE

     FDA today approved a new medical device to treat the

symptoms of enlarged prostate, a condition affecting millions of

men.  The device provides an alternative to treatment with drugs

or surgery.

     The device, the Prostatron, uses microwaves to heat and

destroy excess prostate tissue.  The procedure takes one hour and

can be done on an outpatient basis with local anesthetic.

      Enlarged prostate, medically known as benign prostatic

hyperplasia (BPH), affects more than 50 percent of men age 60 and

older and causes a gradual increase in frequent, difficult

urination, sometimes leading to urinary tract damage.  Treatment

with drugs provides only modest relief.  Surgery, which is still

the most effective treatment, requires anesthesia and may result

in blood loss, impotence and other complications.

     The new device uses a computer-controlled system to target

the prostate gland with microwave heat therapy.  The procedure

has been shown to be safe and effective for treating BPH

symptoms, with no significant effect on sexual function. 

However, it does not correct the problems of incomplete emptying

of the bladder and weak urinary stream.

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                                 Page 2, P96-9, Prostatron



     "This device provides another alternative for men who are

unable, or do not wish, to have surgery for enlarged prostate,"

said FDA Commissioner David A. Kessler, M.D.   "While not a cure,

it effectively treats the symptoms of BPH." 

     FDA's approval of the device was based on clinical studies

of safety and effectiveness submitted by the manufacturer, the

EDAP Technomed Group, of Cambridge, Mass., and on the

recommendation of the Gastroenterology and Urology Devices Panel

of FDA's Medical Devices Advisory Committee, which met in October

1995 to review the product.

     The firm tested the device on 375 men over 45 at seven

medical centers in the United States and Europe.  Urinary

symptoms--urgency, frequency, straining, intermittent flow--

improved in 75 percent of patients.  Follow up four years later

found that the improvement continued in about half; the other

half needed re-treatment with the device, or drugs or surgery at

some time during the four years. 

     The device did not, however, correct the problems of

incomplete emptying of the bladder and weak urinary stream. 

Patients experienced little or no change in the amount of urine

left in the bladder after voiding, and urine flow rate improved

only modestly.

     As a condition of approval, the manufacturer is being

required to extend its study another year to assess the long term

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                                  Page 3, P96-9, Prostatron



effects of the device and the need for re-treatment.  Study

results will also be used to compare the Prostatron to other

treatments for BPH. 

     Because of the device's design, it will be limited to use in

patients with a medium-sized prostate.

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