The Wall Street Journal-20080213-St- Jude to Test Device to Treat Depression

Return to: The_Wall_Street_Journal-20080213

St. Jude to Test Device to Treat Depression

Full Text (298  words)

St. Jude Medical Inc. has won Food and Drug Administration approval to start a trial the company plans to use to pursue U.S. approval for a pacemaker-like device that uses electricity to treat severe depression.

The treatment involves implanting wires in a part of the brain that can be overactive in patients with severe depression, and using electric stimulation from a connected device to calm that activity. There are limited data backing this approach, but St. Jude aims to collect enough evidence in the new randomized study to pave the way to regulatory support.

"Our intent is to receive a PMA as a result of this trial," said Rohan Hoare, vice president of research and development at St. Jude's ANS Division, referring to a type of FDA device approval.

The patients who could potentially benefit from this technology have long-term depression and have failed numerous treatment attempts with drugs or electroconvulsive therapy. About four million Americans are estimated to fit into this category, creating a broad potential market for medical-device companies with effective systems.

A handful of device makers are exploring or have actively pursued the market, including Medtronic Inc., which like St. Jude has deep brain stimulation technology. Northstar Neuroscience Inc. and Cyberonics Inc. are smaller device companies with interest in depression treatment; the latter company has an FDA-approved nerve- stimulation tool but has been stymied by lack of insurance reimbursement coverage.

St. Jude, a St. Paul, Minn., company known for heart-rhythm devices such as pacemakers and defibrillators, has a growing business for devices used to treat certain neurological conditions.

The FDA has granted what is known as an investigational device exemption that clears St. Jude to begin enrollment for the "Broaden" trial, which will start at three centers and then add centers later, Mr. Hoare said.