GE Healthcare (NYSE:GE) introduced Mavric SL, a novel magnetic resonance imaging technique intended to more accurately image soft tissue and bone in patients with joint replacements and other implants.
According to a Hospital for Special Surgery study published in The Journal of Bone & Joint Surgery, MR imaging can detect inflammation of the joint lining (synovitis) in patients with metal-on-metal hip implants long before symptoms appear. This allows for a more conclusive diagnosis and effective planning for follow-up care, GE said in a press release.
"The addition of Mavric SL to a standardized MR protocol is instrumental in providing accurate, reproducible diagnosis of adverse tissue reactions around implants," Dr. Hollis Potter, Chief of MR Imaging at Hospital for Special Surgery in New York and a lead member of the development team, said in a press statement.
"Even in asymptomatic patients, the Mavric SL technology can recognize an issue that needs to be monitored, providing valuable clinical information … that can have significant human and economic costs, particularly when diagnosis is delayed," Potter continued.
Mavric SL is a combination of an acquisition technique and post-processing software intended for use on GE 1.5T and 3.0T MR systems, GE said. It can be used on any patient with passive MR Conditional orthopedic implants that are scanned according to the implant’s conditions of safe use.
Mavric SL helps reduce artifacts caused by presence of metal compared to conventional MR imaging techniques, which allows enhanced tissue visualization near the implant, the company noted. It can also be used on patients without implants that are cleared for MR exams.
The technology, which was cleared by FDA in December, is available in most markets.
In some cases, the Mavric SL can reduce the need for biopsy or exploratory surgery. The technique is non-invasive, radiation-free and needle-free because it does not require a contrast media injection.
Prior to the availability of Mavric SL, achieving quality diagnostic MR images of the anatomy near implants was often impossible due to image distortion caused by metal used in implanted devices, GE notes.
"Current MR technology is limited and MAVRIC SL addresses this major gap in patient care, as the number of procedures requiring MR technologies continues to grow," President and CEO of GE Healthcare’s Magnetic Resonance business unit Richard Hausmann said in a press statement.
More than 1 million hip or knee replacement (arthroplasty) procedures are performed each year in the U.S., according to a 2010 CDC national hospital discharge survey.
In Europe, more than 250,000 such procedures are performed annually, according to 2012 statistics from the Organization for Economic Co-operation and Development (OECD).
The need for arthroplasty revision procedures (a second surgery to correct the failure of an artificial joint) is accelerating due to the increased frequency of joint replacements and the younger ages at which they are being performed, GE noted.
Mavric SL may also help reduce liability to implant manufacturers, who recently came under legal fire for problems surrounding their devices.
By some estimates, by 2030, the number of revision procedures will increase by 137 percent for hips and 601 percent for knees from 2005, GE noted.
Patients with tissue damage from joint replacement surgeries may present with pain and/or altered gait mechanics, or may have no symptoms at all, GE noted.
MR imaging was able to detect inflammation in both symptomatic and asymptomatic patients, helping to identify those patients who may need revision surgery before the surrounding tissue sustains further damage that makes revision more difficult, the company said.
"The development of the Mavric protocol has given us a window into the local tissue response to implants and a better understanding of the underlying cause of patients’ pain and poor function," Dr. Mathias Bostrom, Attending Orthopedic Surgeon, Hospital for Special Surgery, said in a press statement.
"It is well established that there is more morbidity associated with revision in the setting of severe tissue loss, and Mavric SL positions clinicians to provide an early and accurate diagnosis," he added.
