Salt Lake Regional Medical Center First in the U.S. to Perform Meniscus Replacement to Relieve Persistent Knee Pain in SUN Clinical Trial
SALT LAKE CITY, Utah – May 20, 2016 – Salt Lake Regional Medical Center, an IASIS Healthcare hospital, and Active Implants, a company that develops orthopedic implant solutions, today announced that the first meniscus replacement in the SUN (Safety Using NUsurface®) clinical trial has been performed by Dr. Andrew Cooper. Salt Lake Regional Medical Center is the only hospital in Utah – and one of just 10 sites nationwide – enrolling patients with persistent knee pain caused by injured or deteriorating meniscus cartilage in the SUN trial, which is designed to assess the safety and effectiveness of the NUsurface® Meniscus Implant (pronounced “new surface”) in restoring function similar to that of a natural, healthy meniscus.
The recipient of the implant was 55-year- old Uintah resident Kent Carlson, who has experienced meniscus-related problems since he was a child as a result of skiing injuries. He underwent a meniscectomy and has been getting cortisone shots, but the pain has persisted to the point where sitting for long periods or bearing weight are uncomfortable. Even low-impact exercises like swimming and cycling can cause his knee to swell.
The meniscus is a tissue pad between the thigh and shin bones. Once damaged, the meniscus has a very limited ability to heal. Over 1 million partial meniscectomies to remove or repair a torn meniscus are performed in the U.S. every year, about the same as the total number of hip and knee replacement surgeries combined. However, many patients still experience persistent knee pain following meniscus surgery.
“There aren’t many options for patients like Kent, who experienced persistent knee pain following meniscus surgery,” said Dr. Andrew Cooper, orthopedic surgeon. “Damage to the meniscus can lead to arthritis and the need for knee replacement surgery. We hope the NUsurface implant alleviates pain in these patients, as well as helps them delay or avoid knee replacement surgery.”
The NUsurface Meniscus Implant is inserted into the knee joint through a small incision and patients typically can go home soon after the operation. After surgery, they undergo a six-week rehabilitation program. The NUsurface Meniscus Implant has been used in Europe under CE Mark since 2008 and Israel since 2011.
An avid outdoorsman, Carlson is looking forward to getting back into the wild once he recovers from the NUsurface surgery. “I love to hunt, fish and hike,” Carlson said. “I can’t wait to put on a pack and get back out there.”
About the Clinical Trial
The SUN study (Safety Using NUsurface®) will enroll approximately 120 patients as part of regulatory process to gain approval from FDA to sell the device in the U.S. All patients who meet study requirements and agree to enter the trial are offered the NUsurface Meniscus Implant as treatment. Treatment with NUsurface in the SUN trial is eligible for coverage by Medicare and some private insurance companies. To be eligible for the study, participants must be between the ages of 30 and 75 and have pain after medial meniscus surgery that was performed at least six months ago. To learn more about the SUN study, please visithttp://sun-trial.com or call (844) 680-8951.
About the NUsurface® Meniscus Implant
The NUsurface® Meniscus Implant, from Active Implants LLC, is an investigational treatment for patients with persistent knee pain following medial meniscus surgery. It is made from medical grade plastic and, as a result of its unique materials, composite structure and design, does not require fixation to bone or soft tissues. The NUsurface Meniscus Implant mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint. Clinical trials are underway in the U.S., Europe and Israel to verify the safety and effectiveness of the NUsurface Meniscus Implant.
About Salt Lake Regional Medical Center
Salt Lake Regional Medical Center has been caring for the people of the Salt Lake Valley for 140 years. Built in 1875, it was one of the first hospitals in the Salt Lake Valley. Salt Lake Regional offers comprehensive healthcare services, including emergency care, heart care, advanced surgical procedures, diagnostic imaging, maternity care, women’s services and help for a broad range of medical conditions. Currently, the 158-bed hospital encompasses 316,000 sq. ft. of medical facilities, including three medical office buildings on campus. Salt Lake Regional Medical Center is directly or indirectly owned by an entity that proudly includes physician owners, including certain members of the hospital’s medical staff. For more information, visit saltlakeregional.com or call 1-866- 431-WELL (9355).
About Active Implants
Active Implants, LLC develops orthopedic implant solutions that complement the natural biomechanics of the musculoskeletal system, allowing patients to maintain or return to an active lifestyle. Active Implants is privately held with headquarters in Memphis, Tennessee. European offices are in Driebergen, The Netherlands, with R&D facilities in Netanya, Israel. For more information, visit www.activeimplants.com.
CAUTION Investigational device. Limited by United States law to investigational use.