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News

Impliant receives FDA approval to restart TOPS System trial

Impliant : 28 May, 2008  (Company News)
Impliant has received FDA approval to restart patient enrollment in a pivotal IDE trial of its TOPS System, a Total Posterior Arthroplasty device designed to treat spinal stenosis with or without facet arthrosis and spondylolisthesis.
Impliant voluntarily suspended enrollment in the study in September 2007 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 device that allow it to better withstand high shear loads and misalignment while not affecting its range of motion.

Paul McAfee, MD, chief of spine surgery, St Joseph's Medical Center and TOPS 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 chief executive officer of Impliant. 'The resumption of our TOPS clinical study represents the culmination of a lot of hard work and support by individuals both inside and outside the organization. We are especially grateful to all of our investigators for their input, dedication and support over the past several months. We are all very excited to get started again.'

Impliant has enrolled 74 patients to date in its prospective, randomised IDE study comparing the TOPS System to a traditional posterior fusion. The company also currently has 75 TOPS patients enrolled under single and multi-level protocols in Brazil, Belgium, Turkey, and Israel.

Impliant is applying cutting-edge materials and crossbar biomechanical techniques to develop a new class of spine arthroplasty devices that target over 40 percent of the patients worldwide who undergo fusion surgery and could benefit from a Total Posterior Arthroplasty solution.
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