Impliant Restarts European Clinical Trials for Patented Spine System

Impliant has resumed European clinical trials with its TOPS system, a total posterior arthroplasty device used to treat spinal stenosis.

The company voluntarily suspended all trials last September after a third-party expert in medical device retrievals and Impliant’s R&D team determined that misalignment and excessive shear loading caused a device failure.

Impliant has made design and manufacturing changes to the internal components of the device that allow it to better withstand high shear loads and misalignment while not affecting its range of motion, the company said.

The company recently received FDA approval to restart its U.S. clinical study.