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New Medical Device Approved by the FDA

Posted by David L on 7/04/04 at 22:32 (154499)

From: http://www.fda.gov/bbs/topics/answers/2004/ANS01294.html

FDA Clears Medicinal Leeches for Marketing
The Food and Drug Administration (FDA) has for the first time cleared the commercial marketing of leeches for medicinal purposes.

Leeches can help heal skin grafts by removing blood pooled under the graft and restore blood circulation in blocked veins by removing pooled blood.

Leeches have been used as an alternative treatment to blood-letting and amputation for several thousand years. They reached their height of medicinal use in the mid- 1800's. Today they are used in medicine throughout the world as tools in skin grafts and reattachment surgery.

Medicinal leeches (Hirudo medicinalis) are bloodsucking aquatic animals that live in fresh water.

Ricarimpex SAS, a French firm, is the first company to request and receive FDA clearance to market leeches as medical devices. The firm has been breeding leeches for 150 years. They are handled in a certified facility that tracks each lot.

In considering the firm's application, FDA reviewed the published literature on the use of leeches in medicine and evaluated safety data provided by the firm. FDA also reviewed information on how the leeches are fed, their environment, and the personnel who handle them.

FDA determined that leeches are medical devices because they meet the definition of a medical device under the Food Drug and Cosmetic Act. Under the law, a medical device is an article intended to diagnose, cure, treat, prevent, or mitigate a disease or condition, or to affect a function or structure of the body, that does not achieve its primary effect through a chemical action, and is not metabolized.