Endogun Medical Systems Ltd. Receives FDA Approval For Next-Generation Soft Tissue Attachment Device

Main Category: Urology / Nephrology
Also Included In: Women's Health / Gynecology;  Regulatory Affairs / Drug Approvals
Article Date: 29 Apr 2008 - 1:00 PDT

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Endogun Medical Systems Ltd., a leading developer and manufacturer of novel solutions for minimally-invasive fastening of soft tissue, today announced that it has received FDA clearance to market in the USA its next-generation, single-incision, trans-vaginal Endofast Reliant device for soft tissue reinforcement and attachment.

According to Endogun's Chairman of the Board, Elad Naggar, 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 (SUI) markets. 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 and the disorder carries the risks of inflammation and infection.

More than 600,000 procedures are performed annually in the USA and Europe (combined), with direct costs of associated surgical equipment reaching hundreds of millions of dollars. Estimates suggest that close to 7 million women are in need of such treatment; the gap between the potential market size and the actual number of procedures performed to date may stem from the fact that the current surgical offerings are significantly invasive, and require substantial surgical skills.

Endogun's product is aimed at offering a single-incision, simpler and safer procedure, which is performed entirely trans-vaginally.

About Endogun

Endogun Medical Systems Ltd. ("Endogun") was founded in March 2004 to offer improved soft tissue attachment technology and products to the world of Minimally Invasive Surgery (MIS). It offers procedures that are easier for surgeons to use and safer for patients than today's options. Endogun aims to significantly improve the quality and outcome of many minimally invasive procedures in the world of urogynecology and urology.

Endogun Medical Systems Ltd