American Medical Systems, announced today that a major milestone was achieved in the development of its ProstaJect(TM) Ethanol Injection System for the treatment of enlarged prostate glands, a condition known as benign prostatic hyperplasia (BPH). The company's application to the FDA for an investigational new drug application (IND) is now effective. AMS officials said ProstaJect investigators would begin enrolling patients at 15 U.S. medical centers early this year in the first phase of clinical evaluations to evaluate safety and tolerability of ethanol injections into enlarged prostate glands.
The AMS procedure does not remove the gland. Instead, physicians will use a slim, specialized injection system to deliver ethanol to ablate (destroy) the cells in the prostate gland. In European marketing clinical studies, some urologists have performed the procedure in as little as 20 minutes under local anesthesia with intravenous sedation.
Douglas W. Kohrs, president and chief executive officer of AMS noted, "The new therapy holds promise for millions of aging men, as a first-line option for proactive treatment of BPH. The ProstaJect System will potentially offer a patient-friendly alternative that is less invasive and less costly than current BPH treatments."
10-Jan-2001 (Source: Newsdesk)
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