Impliant had voluntarily suspended all clinical activities 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 R&D 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. The company has also received FDA approval to restart its Tops IDE clinical study in the US.
John Sutcliffe, lead clinician of the London Spine Clinic, said: “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.”