Soft Tissue Fastener Cleared for Marketing
A new internal, soft tissue fastening solution manufactured (pdf) by Endogun Medical Systems, Limited was cleared for marketing by the Food and Drug Administration. The EndoFast Reliant is designed for use during minimally invasive procedures to repair the female pelvic floor. This is the newest version of the EndoFast Reliant, as described in the news release issued by Endogun Medical.
This tool allows procedures to be completed through an entirely transvaginal approach. This minimizes the associated risks and limits the procedure to a single incision.
The product is particularly intended to treat patients with stress urinary incontinence (SUI) and prolapse. Prolapse is associated with weakened pelvis muscles that support internal organs including the bladder, rectum, vagina, and uterus. Patients with prolapse often experience feelings of heaviness or discomfort. Prolapse also heightens a patient’s risk of developing an infection, as well as inflammation.
Endogun is dedicated to the development of products to support soft tissue attachment along with tools for minimally invasive surgery. The company primarily specializes in design of tools to support clinicians practicing urogynecology and urology.
April 29, 2008 Related topics: Product Approval & Certification, Surgery, Obstetrics, Gynecology & Neonatology