Eden Spine’s Sphynx plating system has won FDA clearance, the company said today. Sphynx was designed to complement the company’s Giza titanium vertebral body replacement with rotatable endplates, introduced in 2012. The Giza is intended to replace and fuse a collapsed, damaged, or unstable vertebral body due to a tumor or a fracture and provides multiple […]
Eden Spine
Boston Scientific touts CE Mark for spinal stimulator lead | Regulatory Roundup
Boston Scientific (NYSE:BSX) landed CE Mark approval in the European Union for its Infinion 16 percutaneous lead, designed for use with the company’s Precision Plus spinal cord stimulator system.
BSX’s spinal cord stimulator leads are designed to mask pain signals to the brain by delivering electrical pulses from an implantable pulse generator.