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 required while helping me to limit cement inadvertently getting into the spinal canal. The control gained from this technology will allow me to treat patients which have posed challenges in the past due to complicated fractured anatomy.”
“The system has the added advantage of being a unilateral treatment which reduced the invasiveness of the procedure and has the potential to reduce radiation exposure for the patient and our surgical team,” added Marks.
The company’s existing portfolio includes the C3 Curved Osteotome Kit, which the company says, uses a unilateral, curving cavity creator to create a central cavity which spans the sagittal midline, or target areas for cavity creation. An adjustable blade is used to create the cavity. Degree of blade adjustment allows for the creation of cavities with a diameter to match the anatomical requirements of each fracture.
Soteira is a privately held venture-backed company incorporated in 2004 to develop and market a new generation of technologies for the treatment of vertebral compression fractures. In 2008, the company established a subsidiary company, Soteira GmbH, to lead the company’s European commercialization efforts. Sotiera GmbH currently manages distribution of the Soteira products in Germany, Spain, Italy, Belgium, and Austria