This is an archive page. The links are no longer being updated.
Date: Monday, May 6, 1996 FOR IMMEDIATE RELEASE Contact: Sharon Snider (301)443-3285
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.
"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 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.