Inlet Medical, Inc., Receives FDA Approval for Metra(TM) PS
MINNEAPOLIS, July 15 /PRNewswire/ -- Inlet Medical, Inc., announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Metra(TM) PS kit, a disposable surgical kit developed for use in a new minimally invasive uterine repositioning procedure to treat pelvic pain in women.
The first peer-reviewed journal article on the new procedure was published in the May issue of the Journal of Reproductive Medicine. It summarizes a two-year study involving 75 women with chronic pelvic pain, including pain associated with menstruation or intercourse because of a retroverted or tipped uterus. Among patients for whom a retroverted uterus was the only significant pathologic finding, 90 percent had immediate and sustained relief from their symptoms, the study showed. The surgeries took an average of 12 minutes to perform. All were performed as outpatient procedures with same-day discharge.
The Inlet surgical kit provides complete instrumentation for laparoscopic uterine suspension. Physician training programs are in progress and market release will begin this month.
``We believe that many women who suffer from painful intercourse or painful menstruation can be treated with the new procedure and the Metra(TM) PS kit, but that these are topics that women rarely discuss with their physicians,'' said Lee A. Jones, president and chief executive officer of Inlet Medical. ``For that reason we have established a Web site for consumer education: http://www.inletmedical.org . The Internet is a perfect medium to discuss sensitive issues, and our site is starting to get a lot of attention.''
Inlet Medical, Inc., based in Eden Prairie, Minn., is a privately held company focusing on improving women's health through the development of medical tools for use in minimally invasive surgical techniques. The company's products include a high-quality line of instruments used for the placement and manipulation of sutures in laparoscopic procedures.
For more information, contact Tom Langenfeld of Swenson NHB Investor Relations, 612-371-0000, for Inlet Medical, Inc., or Lee A. Jones of Inlet Medical, Inc., 612-942-5034.
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