Soteira Enters U.S. VCF Market (Walter Eisner @ OTW)
Soteira Inc. of Natick, Massachusetts, has received clearance from the Food and Drug Administration (FDA) to market the company's Shield Kyphoplasty System in the U.S.
In the December 12 press release, Larry Jasinski, Soteira's president and CEO, said the 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." Jasinski also said the technology is the "first of its kind" to obtain 510(k) clearance from ...
