The US Food and Drug Administration (FDA) has given 510(k) clearance to Soteira for its Shield Kyphoplasty system.
The Shield Kyphoplasty system is designed to give the physician control of cement placement during vertebral augmentation procedures.
“The Shield Kyphoplasty system includes a unilateral, steerable cavity creator and a self expanding stent-like implant designed to direct PMMA cement flow for optimal placement during vertebral augmentation. This advanced augmentation technology will give physicians a new level of control and is the first of its kind to obtain 510(k) clearance,” said Larry Jasinski, Soteira’s president and CEO. “With the addition of the Shield to the existing Soteira portfolio and an active short-cycle pipeline, we are continuing to work toward offering the most comprehensive product portfolio for vertebral compression fracture treatment in the global market.”
The Shield Kyphoplasty system 510(k) clearance was supported with extensive laboratory, animal, cadaver and clinical testing which included a Level 2 (pilot trial) and a Level 1 (randomised controlled trial.)