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-growth period. Coloplast designed the anchors to maximize holding force and minimize tissue damage. One anchor is static in placement, while the other is dynamic, allowing for two-way adjustability and proper tensioning.
Unique Introducer Aids Implementation
Altis has a helical type introducer with visual marking to guide placement during the surgical procedure. The introducer controls the placement of the anchors in the obturator space and relies on the integrated tensioning systems built into the anchors for positioning the sling.
This technique is designed by surgeons to allow for ease of passage to the ramus.
Dr. Ty Erickson, implanter on the IDE study, said, "With reproducible controlled passage through tissues and the lightest weight mesh available, Altis pushes minimally invasive slings to the next level. Designed to aid surgeons, this new implant is showing positive outcomes, greatly reducing the potential of complications while providing effective support."
A Danish based medical device company with its United States headquarters in Minneapolis, Coloplast develops medical devices and services designed to make life easier for people with very personal and private medical conditions. We start by listening to our physician users to better understand their needs and their patients' medical conditions, and then respond by bringing the best ideas to market in the form of medical devices and service solutions.
Coloplast's businesses include ostomy care, urology care, continence care, and wound and skin care. With the development of a strong portfolio of new products and investments in a professional sales force, Coloplast now employs around 8000 people worldwide. In 2012, Coloplast received global recognition for having the best corporate reputation among patients (PatientView), and for being the Most Ethical (Ethisphere Institute) and Most Sustainable (StoreBrand Bank) company.
To learn more about Coloplast, visit www.us.coloplast.com.