Humanitarian Device Exemption

Medtronic's Enterra™ Therapy gastric pacemaker was approved as a Humanitarian Use Device in 1999 by the U.S. Food and Drug Administration.

This designation recognizes that the benefit of utilizing the device outweighs the risks to the patient from its use; and that the use of the device may be indicated in fewer than 4000 patients in the U.S. each year.

The Enterra™ gastric pacemaker is a recognized Class 3 Device by the Therapeutic Products Division at Health Canada.

The opportunity is here to improve the quality of our lives, improve my general health, remove the immediate costs associated with my current treatment and reduce my consumption of health care resources in the future.

The Ontario Ministry of Health maintains that our system provides comprehensive and compassionate care to patients.

In this case, the compassionate treatment is to re-insert the gastric pacemaker.