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MINNEAPOLIS, Nov. 13, 2012 /PRNewswire/ -- Coloplast today announced the U.S. launch of its new surgical urology and gynecology medical device, the Altis® Single Incision Sling System (SIS).
Altis received FDA clearance on November 5, 2012, based on Coloplast's submission of an Investigational Device Exemption (IDE) Study, which included implant data. Altis is a unique, minimally invasive sling that combines integrated two-way tensioning with lightweight sling material to provide strength, security and adjustability.
Designed with surgeons to address unmet needs, Altis provides physicians with an innovative adjustability mechanism during implantation and an introducer designed for safe, repeatable anchor placement, avoiding obturator vascular and nerve bundles. The dynamic tensioning system allows for the sling to be intra-operatively adjusted for proper support under the urethra. Altis is made from the lightest, knitted monofilament polypropylene and has low elasticity.
"Listening and responding—to physicians and their patients' needs—is at the heart of Coloplast. It is how we deliver a variety of solutions to physicians to use in their treatment of the intimate health care needs of their patients. Altis is a great example of the innovation enabled by ongoing dialogue; a sling that accommodates individual patient anatomy, provides easier implantation and delivers optimal urethral support," said Eric Halvorson, Global VP of Surgical Urology, Coloplast US.
Minimal Passage Through Skin Aids Physicians
Altis is different from existing products, as it does not require passage through abdominal skin exits for anchoring or tensioning. The elimination of skin exits allows the Altis sling implant to be smaller and the implantation procedure to be streamlined.
Dynamic Anchor Creates Two-Way Adjustability
The Altis sling has two innovative anchors to hold the sling in place during the tissue in-growt
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