April 27, 2017
DENVER–(BUSINESS WIRE)–Advanced Orthopedics & Sports Medicine Specialists, a regional leader in comprehensive orthopedic services, and Active Implants, a company that develops orthopedic implant solutions, today announced that the first meniscus replacement procedures in Colorado have been successfully performed by Dr. Wayne Gersoff. Advanced Orthopedics & Sports Medicine Specialists is the only center in Denver – 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 58-year-old Golden resident Kathleen Cohan, who tore her meniscus on both knees during a head-on collision over 35 years ago. Although she underwent two partial meniscectomies to treat the tears, she continued to experience knee pain. The pain became so severe that over the last six years, Cohan has dealt with constant burning and stiffness in her knees. As an avid backcountry skier, she was forced to cut down her skiing from 60 days to only two days a year. She was unable to go hiking, rock climbing or even walk for more than three miles. Cohan’s pain had persisted to the point where she had to take painkillers on an almost daily basis.
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 are limited options for patients who experience persistent knee pain following meniscus surgery,” Dr. Gersoff said. “Our hope with the NUsurface implant is that it will alleviate pain in these patients, helping them to delay or avoid knee replacement surgery, and allowing them to return to the activities they enjoy.”
Cohan received the NUsurface Meniscus Implant on May 21, 2016, through a small incision in her right knee and completed a six-week rehabilitation program. It has been almost one year since her surgery and the constant burning pain in her right knee has fully subsided. In addition to her daily leisure activities, she has even returned to backcountry skiing and hiking on a regular basis. Most recently, Cohan went on an adventure trip in Costa Rica with a stable knee, which included rough and steep walking surfaces, class IV river rafting, zip lines and hanging bridges.
“Receiving the NUsurface Meniscus Implant has really helped me return to my active sports lifestyle,” Cohan said. “Avoiding joint replacement is very important to me, and I am hopeful that this implant will help me delay knee replacement for another 10 years.”
The NUsurface Meniscus Implant has been used in Europe under CE Mark since 2008 and Israel since 2011.
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 visit http://sun-trial.com or call (844) 680-8951.
About the NUsurface® Meniscus Implant
The NUsurface® Meniscus Implant 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 Advanced Orthopedic and Sports Medicine Specialists
Advanced Orthopedic and Sports Medicine Specialists is widely recognized as the regional leader in comprehensive orthopedic services. The physicians of Advanced Orthopedic and Sports Medicine Specialists have received specialized training in orthopedic surgery and in subspecialty areas within the field of orthopedic medicine. Advanced Orthopedic and Sports Medicine Specialists specializes in providing comprehensive sports medicine services including the diagnosis and treatment of athletic injuries. We now have 9 Orthopedic Surgeons, 2 Podiatric Surgeons and 1 Board Certified Interventional Physiatrist. Our practice is comprised of surgeons who specialize in sports injuries, upper extremity, spine disorders, total joint replacements, carticel implantation, podiatry abnormalities, musculoskeletal disorders, and surgical and non operative treatment of the neck and spine. Advanced Orthopedic and Sports Medicine Specialists has two locations which offer state of the art digital imaging: our Lowry Office in Central Denver and our Lincoln office located in South Denver. For more information, visit http://www.advancedortho.org/ or call our main office at (303) 344-9090.
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.
For Active Implants, LLC
Joni Ramirez, 323-532-0746