ELANA has been used in Europe since 1993. The ELANA technique was approved in the European Union and in Canada. In the USA, however, the ELANA technique is considered investigational and is not currently approved by the Food and Drug Administration (FDA) for the treatment of patients.
In order to obtain FDA approval for the ELANA technique, the US Government has required that data from all international surgeries, where the ELANA technique was used, be collected and reviewed. For this reason, an international multicenter research study is currently being conducted in the USA and Europe. Once the ELANA procedure is approved, it is possible for patients in the USA to have a bypass created with the ELANA system. If your surgeon feels that the ELANA procedure may be appropriate for you, more information is available at: www.elana-study.com