May 24 2013
Algea Therapies, a division of Globus Medical Inc. (NYSE: GMED), committed to finding innovative, minimally invasive solutions that treat pain and restore quality of life, today announced the launch of the SHIELD™ Vertebral Compression Fracture (VCF) System, a next generation fracture management and vertebral augmentation platform for patients with vertebral compression fractures.
"We are excited to announce the US launch of the SHIELD™ VCF System, the first vertebral augmentation implant to guide cement flow into the anterior region of the vertebral body, while significantly decreasing overall cement leakage compared to traditional VCF methods. The system features a new surgical technique involving unipedicular cavity creation, and a novel cement-directing device, the SHIELD™ implant. With this innovative platform technology, Algea is setting a new standard for safer treatment of vertebral compression fractures," commented Sean Suh, Senior Group Manager of Algea Therapies.
The SHIELD™ VCF System marks a new level of control in the vertebral body augmentation market. The system is engineered with strategic flow openings designed to give the physician control of cement placement and reduce cement leakage. The system includes the C3 Curved Osteotome, a steerable, unipedicular, curving cavity creator with an adjustable blade. This instrument allows physicians to create a central cavity spanning the sagittal midline for balanced cement augmentation. The C3 Curved Osteotome has the ability to steer and navigate around difficult and damaged anatomy, creating cavities to match the anatomical requirements of each fracture.
Indications for Use
The SHIELD™ VCF System is intended to provide control of cement flow during injection of PMMA bone cement that has been cleared for use in vertebral augmentation for the treatment of acute, persistently painful (after a minimum of 6 weeks of conservative care), stable, anterior column osteoporotic compression fractures (wedge or concave) of the vertebrae at levels T4 to L5 in the adult spine.