NATICK, Mass.–(BUSINESS WIRE)–Soteira Inc., today
announced the 510(k) clearance of the Shield Kyphoplasty System. Soteira Inc.
President and CEO, Larry Jasinski, stated “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. 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 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 (Randomized Controlled Trial.)
Soteira Inc. is a Privately held venture-backed medical
device company that engages in the development and commercialization of
products used in osteoporotic bone repair. Osteoporotic vertebral compression
fractures are a significant issue to the aging population which is continuing
to expand, illustrated by the forecast of 200,000 compression fracture
interventions in the US
expected in 2012. (iData Research.)
Soteira can be contacted at 508-651-2611, x106 or via the
company website: www.soteira.com.
Posted by Sean Fenske, Editor-in-Chief, MDT
