PRINCETON, N.J., June 26 /PRNewswire/ -- Impliant, Inc., a developer of novel spine arthroplasty alternatives to fusion surgery, today announced that it has resumed European clinical activities on its TOPS(TM) System, a Total Posterior Arthroplasty device designed to treat spinal stenosis with or without facet arthrosis and spondylolisthesis. The procedure was performed by the Lead Clinician of the London Spine Clinic, Mr. John C. Sutcliffe, MB ChB, FRCS.
Impliant had voluntarily suspended all clinical activities in September of last year following one device-related failure. After an extensive investigation conducted by a third-party expert in medical device retrievals and the Impliant Research and Development team, it was determined that device misalignment coupled with excessive shear loading caused the failure. As a result, Impliant has made a few minor design and manufacturing changes to the internal components of the TOPS(TM) device that allow it to better withstand high shear loads and misalignment while not affecting its range of motion.
"I am pleased with the changes Impliant has made to the TOPS(TM) System," said Mr. Sutcliffe. "I feel the device is now even better suited to stabilize the spinal segment after performing the wide decompression that my severely stenotic patients require. However, it should be noted that all of my patients with the original TOPS(TM) design continue to do extremely well, some of which have reached 12 months post-op."
Marcus Klarl, Vice President of European Clinical Affairs for Impliant, stated, "We are pleased to resume our TOPS(TM) clinical activities outside the United States and build upon the excellent outcomes generated to date by Mr. Sutcliffe and our other TOPS(TM) investigators."
The TOPS(TM) single and multi-level family of pro
|SOURCE Impliant, Inc.|
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