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Soteira Inc., Obtains 510(k) Clearance for Shield Kyphoplasty System

Tue, 12/13/2011 - 5:17am
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

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