Soteira, a developer of osteoporotic bone repair products, has received the US Food and Drug Administration (FDA) 510(k) approval for its Shield Kyphoplasty System.
The FDA clearance is based on the laboratory, animal, cadaver and clinical testing which included a Level 2 (Pilot Trial) and a Level 1 (Randomized Controlled Trial).
Soteira president and CEO Larry Jasinski said the Shield Kyphoplasty System comprises a unilateral, steerable cavity creator and a self expanding stent-like implant which is designed to direct PMMA cement flow for optimal placement during vertebral augmentation.
"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 VCF treatment," Jasinski said.