Paradigm Spine, LLC Completes Enrollment in Pivotal Clinical Study of coflex(R) Interlaminar Technology
Published: Mar 29, 2010
NEW YORK--(BUSINESS WIRE)--Paradigm Spine, LLC, a developer of innovative non-fusion and fusion spinal implant solutions, announced today that it has completed patient enrollment in an Investigational Device Exemption (“IDE”) pivotal clinical study comparing the coflex® interlaminar technology to instrumented posterolateral fusion in the surgical treatment of spinal stenosis. Data from this trial will be used to support the coflex® interlaminar technology Pre-Market Approval (“PMA”) application. The study is a prospective, randomized and concurrently controlled clinical study involving more than 380 patients at 21 sites within the United States. The coflex® technology, with over 15 years of clinical heritage outside the U.S., has been implanted in more than 50,000 patients, and is selling in over 40 countries worldwide.