Impliant Restarts Pivotal Clinical Trial for Patented TOPS(TM) Sp...( PRINCETON N.J. May 27 /- Impliant...),Health

PRINCETON, N.J., May 27 /PRNewswire/ -- Impliant, Inc., a developer of novel spine arthroplasty alternatives to fusion surgery, today announced that it has received FDA approval to restart patient enrollment in a pivotal IDE trial of its TOPS(TM) System, a Total Posterior Arthroplasty device designed to treat spinal stenosis with or without facet arthrosis and spondylolisthesis.

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Impliant voluntarily suspended enrollment in the study 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.

Paul McAfee, M.D., Chief of Spine Surgery, St. Joseph's Medical Center and TOPS(TM) Principal Investigator, stated, "Impliant should be commended for the responsible way they responded to the one device failure encountered in the study. Excessive shear force has contributed to the failure of several posterior motion devices. I believe the shear testing conducted by Impliant will become the new standard for all posterior motion devices going forward. I am impressed by the level of detail in their investigation in diagnosing and fixing the issue. I look forward to resuming the study and building upon the outstanding clinical results generated thus far in the IDE and under protocol outside the United States."

"This is a very gratifying day for Impliant," commented Todd Potokar, President and CEO of Impliant. "The resumption o
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