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 the FDA.
The new system, in addition to the company's existing portfolio and an "active short-cycle pipeline," allows Soteira to "work toward offering the most comprehensive product portfolio for VCF (vertebral compression fracture) treatment in the global market," continued Jasinski.
Michael Marks, M.D., MBA, a spine surgeon and chief of staff at Norwalk Hospital in Norwalk, Connecticut, said the system is an exciting new development for spine surgery. "The Shield System allows me to successfully inject cement into an implant within the vertebral body which will give the structural support re...
