FDA Clears Bladder Fastener For Female Urinary Incontinence
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FDA Clears Bladder Fastener For Female Urinary Incontinence

MARLBOROUGH, Mass., March 5, 1997 -- The U.S. Food and Drug Administration (FDA)has cleared two suture fasteners for use in treating female urinary incontinence due to urethral hypermobility.

Female urinary incontinence can result when the bladder sags from its original position and alters the architecture of the urinary retention structures within the urinary tract. Pain and reproductive problems can occur when the uterus sags from its normal position and impinges upon adjacent tissue structures.

Innovasive Devices, Inc. (Nasdaq: IDEA), a manufacturer of proprietary soft tissue repair systems, manufactures the ROC and ROC XS suture fasteners, polymer-based devices that hold soft tissue against bone. These fasteners can be used to attach and elevate the sagging bladder neck or uterus to the pubic bone. In addition, the Company's suture fasteners can be applied in either an open or minimally invasive
laparascopic surgical procedure.

Innovasive Devices, Inc. designs, develops, manufactures and markets proprietary tissue repair systems which facilitate the repair of soft tissue injuries. The Company's tissue repair systems are designed to be used in either open surgical or minimally invasive arthroscopic procedures.


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