Repairing Soft Tissues in a Trans-Vaginal Approach

A novel solution for minimally invasive fastening of soft tissue could offer simpler, safer prolapse and stress urinary incontinence (SUI) repair procedures.

The EndoFast Reliant single-incision, trans-vaginal device is intended for soft tissue reinforcement by attaching a mesh to soft tissue using unique fasteners. The tissue-fastening system aids in adapting open, higher-risk procedures to simpler and more effective treatments, reducing associated procedural risk, post-operative side effects, and potentially also reducing the level of anesthesia needed for such procedures. A special spider web-like fastener is inserted into the body via minimally invasive means; this fastens a thin net beneath the organs in a woman's pelvic area, which have collapsed because of age or childbirth. The fasteners are inserted using a gun-like device with a "trigger” that fires the fastener into the tissue. The EndoFast Reliant is a product of Endogun Medical Systems (Kibbutz Haogen, Israel), and has been approved by the U.S. Food and Drug Administration (FDA).

"The FDA approval for our single use, disposable EndoFast Reliant product is a key milestone towards bringing Endogun's products to the prolapse and stress urinary incontinence markets,” said Elad Naggar, Endogun CEO. "This regulatory approval, together with very positive clinical validation from key opinion leaders, indicates a product with a unique value proposition. We believe that our solution may have significant advantages over what is available today, for patients, physicians, payers and providers.”

Pelvic organ prolapse occurs in women--often following multiple births or excess weight--and develops as a result of weakening of the pelvic muscles, which support internal organs (womb, bladder, rectum and vagina). Side effects of this condition include discomfort, a feeling of heaviness, and pain. The disorder carries the risks of inflammation and infection.


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Endogun Medical Systems