Pivotal Research Solutions has successfully represented Link Orthopaedics, Inc. in a clinical trial for the Scandinavian Total Ankle Replacement (STAR) as the clinical research organization (CRO). On April 24, an FDA Advisory Panel voted to recommend approval of this device, with conditions.

"Members of the staff of Pivotal Research have worked with Link Orthopaedics on this study since its initiation in 2000, and are pleased and gratified at its evident outcome," said Jeanette E. Ahrens, PhD, president and CEO of Pivotal Research Solutions. Dr. Ahrens, whose doctorate is in biomedical engineering, has played an integral role in the effort of preparation and presentation of this study to the FDA.

More than 600 subjects were followed for this study after being treated with the STAR device in one of 15 clinical sites across the US. Pivotal Research Solutions' role included the auditing of the study management and the clinical data collection for each of these sites, as well as the statistical and scientific support.

Link Orthopaedics President Andrew Greenberg officially singled out Pivotal Research Solutions for its contributions to the successful outcome of the STAR study in the Link press release dated April 25, 2007.

Pivotal Research Solutions manages clinical trials exclusively for medical device manufacturers, and specialized in orthopaedic device trials.