Osseoplasty: Review and Analysis of 1081 Cases in the United States and Europe

SUMMARY This report is a retrospective analysis of 1081 reported clinical cases performed by 206 physicians in the United States, UK, Italy and Spain from November 3 rd, 2008 through November 2 nd , 2010, using the Osseoflex and Osseoperm vertebral augmentation system in the treatment of symptomatic vertebral compression fractures. As cases were performed by numerous clinicians in multiple sites, and without the structures of a clinical trial, some data are necessarily unavailable. It is, however among the largest reviews performed to our knowledge for any commercially available system for percutaneous treatment of compression fractures. Response data was collected from over 50 patients among the first 300 procedures. This confirmed substantial pain reduction in the vast majority of patients that at least equals the relief produced by all other currently available balloon or straight needle systems. Technical issues initially included clogging of the needle, and isolated instances of device failure largely due to violation of recommended procedure parameters by individual physicians. Redesign of the tip effectively eliminated clogging, and only 4 cases out of 428 since the new release experienced device failure. No adverse clinical sequelae resulted from any of these events. Cement extravasation was documented in 5.7% of the 1043 US levels for which data are available. No new or severe complications unique to the Osseoflex system were recorded. The reported experience from 206 physicians, 39 states and three European countries demonstrates the Osseon system to be effective, safe, and more efficient than any commercially available system in the world.