Prosurg Inc Receives U.S. Food and Drug Administration (FDA) Marketing clearance for Mini-Sling ™ - Adjustable Urethral Sling System for Treatment of Stress Urinary Incontinence (SUI) and Easy Lift ™- Single Incision, Modular Mesh System for Pelvic floor Repair & Reconstruction Surgery.
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San Jose, Calif. July 5, 2007--Prosurg Inc announced receipt of marketing clearance from the U.S. Food and Drug Administration (FDA) for Mini-Sling ™ - Adjustable, Urethral Sling System with Bioabsorbable Anchors for treatment of Stress Urinary Incontinence (SUI) and Easy Lift ™- Single Incision, Modular Mesh System with ‘Snap-on’ Anchors for Pelvic body organ Repair & Reconstruction Surgery via Trans-vaginal approach.
Mini Sling™- Adjustable Urethral Sling is a single use urethral support device, designed for novel, in- office treatment of female Stress Urinary Incontinence (SUI). The Mini Sling consists of central section of macro-pore, mono filament polypropylene mesh, and self anchoring, tissue fixation anchors made from Bioabsorbable polymer material. The Mini-Sling can be delivered into fibro-muscular tissue, surrounding the urethra via ergonomically designed, curved introducer. The Bioabsorbable tissue fixation anchors secures the Mini Sling into the fibro-muscular tissue and provide tension- free support to the urethra, until more permanent urethral support is generated by natural tissue fibrosis process. The Self anchoring fixation anchors of the Mini Sling and the introducer tip profile are designed for Quick Connect and Release of the sling from introducer, to facilitate controlled delivery and placement of the Min- Sling through single vaginal incision. The Mini –Sling can also be delivered using a newly designed needle introducer with Slide Control mechanism.
The Mini –Sling procedure can be carried out in less than 15 minutes in a physician’s office or in an ambulatory center under local anesthesia. The Mini-Sling family of products are available in three major configurations (1) Mini Sling with Fixed tissue fixation anchors (2) Mini Sling with Adjustable tissue fixation anchors (3) Mini-Sling with Modular ‘Snap-on’ tissue fixation anchors , ideally suited for patient’s anatomy and physician’s preference to achieve optimum clinical outcome. The introducer device is available in two different configurations (1) Narrow flat blade introducer with notched tip profile and (2) Needle introducer with ‘slide control mechanism for controlled delivery.
The Easy Lift™- is a Single- Incision, Modular, Surgical Mesh System with ‘Snap-on’ Bioabsorbable polymer Anchors for Pelvic Floor Repair and Reconstruction Surgery via Trans-Vaginal approach. The Modular, self anchoring tissue fixation anchors can be attached to any mono –filament, Polypropylene Surgical Mesh or Biological Tissue Matrix, simply by snapping them together. The ‘snap-on’ modular anchors for mesh are made of Bioabsorbable co-polymer with bio- degradation life profile of approx. 3-6 months. The Surgical mesh can be delivered via single vaginal incision in to anterior and posterior region of the pelvic floor using needle introducer device with Slide Control mechanism. The modular anchors attached to the surgical mesh can provide necessary tissue fixation means and support for prolapsed pelvic floor body organs, including bladder, rectum, colon, uterus and vagina. The novel concept of Modular, ‘Snap-on’ anchors and Self Anchoring design feature provides physician with wider range of options to customize and select optimum graft or surgical mesh material combined with minimally invasive delivery approach for pelvic floor repair and reconstruction surgery.
The Easy Lift™ - Universal Pelvic Repair & Reconstruction System with Modular, ‘Snap-on’ Anchor configurations is designed for a single vaginal incision, minimally invasive surgical treatment for surgical repair & reconstruction of pelvic floor organs including Vaginal vault prolapse, Bladder prolapse (Cystocele) or Rectal prolapse (Rectocele),Uterine prolapse, Small bowel prolapse ( Enterocele), using polypropylene mesh or biological tissue matrix.
“The Single- Incision, Universal Trans-Vaginal approach for Pelvic Floor Repair and Reconstruction Surgery using Easy Lift™- Modular System does not require any painful skin incisions or exit wounds from the long needles required for introduction & retrieval of anchoring tails, attached to the surgical mesh. The surgical mesh can be delivered vaginally, via single incision and anchored in the muscle tissue or fascia, surrounding the prolapsed body organ, using self anchoring, bioabsorbable anchors. The Surgical mesh with modular anchors can be deployed and secured in the tissue, using needle introducer with slide control mechanism or simply by push of a index finger.” commented Ashvin Desai President and Chief Executive Officer of Prosurg, Inc.
About Prosurg, Inc
Founded in 1989, Prosurg, Inc is dedicated to develop, manufacture and market innovative products based on the state of the art technology for treatment of Urological, Uro-Gynecological & gynecological diseases and disorders. Prosurg inc is committed to provide cost effective treatment options for men's and women's health. For additional information, please visit www.Prosurg.com