Salt Lake-based Rubicon Medical Corp. said Thursday it has completed clinical testing of the Rubicon filter on its initial enrollment of more than 30 human cases in a study in Europe.
Physicians have tested the device in both saphenous vein grafts and native coronary arteries, including high-risk stenting procedures.
Rubicon will collect follow-up data from the initial case studies during the next 30 days as part of the clinical study protocol. The company then plans to use the collected data to generate the necessary reports and file for regulatory approval for marketing clearance for the Rubicon filter in Europe.
The Rubicon filter also is undergoing clinical studies in Europe for its use in carotid stenting procedures. The company anticipates completing those studies in the near future through the same process.
Rubicon has not started trials on the filter in the United States but expects to begin trials this year.