FDA Clears New Sling System As Treatment Option In Women.

2001 SEP 13 - (NewsRx.com & NewsRx.net) -- American Medical Systems (AMS) announced that the U.S. Food and Drug Administration has cleared the AMS SPARC Sling System for commercial marketing in the United States. The system is designed to offer a superior surgical approach to placing a sling for the treatment of female stress incontinence.

Sling procedures, which support the urethra, currently represent more than 40% of the total number of surgical procedures for incontinence.

"The SPARC system has been designed to provide a new, potentially safer and simpler option for the placement of a sling," said Doug Kohrs, AMS. "The SPARC system joins a rapidly growing AMS product line and will provide another innovative option for the treatment of female incontinence."

David Staskin, MD, of Harvard Medical School, Boston, Massachusetts, noted that the system and its suprapubic approach provide unique advantages. "We believe that with passing of the thin needles from above the pubic bone, rather than below, the risk of perforating the bowel or damaging blood vessels near the bladder will be substantially less than with a vaginal approach. Using the pubic bones as an anatomical guide will allow surgeons to stay within the safety zone of the retropubic space. In addition, only one cystoscopy is required to confirm the integrity of the urethra and bladder."

"The technique is minimally invasive and most patients are able to return home the same day," Staskin added. "Surgeons already skilled in the transvaginal or suprapubic approaches or those interested ...