FDA OKs brain stimulator for depression

The government on Friday approved a new therapy for the severely depressed who have run out of treatment options: a pacemaker-like implant that sends tiny electric shocks to the brain.

The Food and Drug Administration’s clearance opens Cyberonics Inc.’s vagus nerve stimulator, or VNS, as a potential treatment for an estimated 4 million Americans with hard-to-treat depression — despite controversy over whether it’s really been proven to work.

“These are patients pretty much at the end of the line in terms of what treatment options are available to them,” said FDA medical device chief Dr. Daniel Schultz, who said he personally was persuaded by Cyberonics’ research despite initial skepticism within his agency.

The pacemaker-like implant has been sold since 1997 to control intractable epilepsy, a much smaller market.

A generator the size of a pocket watch is implanted into the chest. Wires snake up the neck to the vagus nerve, delivering tiny electric shocks through that nerve and into a region of the brain thought to play a role in mood.

Cyberonics began a 200-patient study to see whether VNS could treat depression patients not adequately helped by other therapies. An FDA review last year found no difference after three months of implant treatment. Cyberonics argued that a year later, a significant number of the VNS recipients had had their depression ease.

That yearlong follow-up hadn’t been done according to standard scientific procedures — it wasn’t a randomized controlled study — and thus critics questioned its validity.

For Subscribers

FOR SUBSCRIBERSAbdul El-Sayed tries to woo MAHA voters as Democrats seek inroads with RFK’s supporters

FOR SUBSCRIBERSKratom-like substances are popping up in a typically benign supplement

FOR SUBSCRIBERSGOP super PAC increases its spending for Sen. Jon Husted in tough Ohio race

FOR SUBSCRIBERSRecords reveal tumultuous marriage between slain New York Times executive and wife

FOR SUBSCRIBERSFrom clean energy warrior to ‘wall of shame,’ James Talarico reverses on a fossil fuel money pledge

FOR SUBSCRIBERSCongressional staff planned official trip with luxury stops in Italy and France weeks before election

FOR SUBSCRIBERSA harrowing ordeal aboard an Israel-bound plane

FOR SUBSCRIBERSOpenAI CEO Sam Altman to skip congressional hearing on rogue AI agents

FOR SUBSCRIBERSKey DOJ lawyers departed Trump ‘grand conspiracy’ probe amid pressure to produce, source says

FOR SUBSCRIBERSTrump’s new AI chatbot often links to a site launched under Clinton 26 years ago

FOR SUBSCRIBERSAt MAHA summit, industry CEOs the movement once vilified take the stage

FOR SUBSCRIBERSThis Paralympian has two goals: Win medals and give away $500,000 to her teammates

FOR SUBSCRIBERSCornell rape allegation spotlights stringent New York state laws that have long drawn criticism

FOR SUBSCRIBERSThe debate over AI’s future rages on both coasts

FOR SUBSCRIBERSDecades-old march dispute reignites in Northern Ireland, threatening political crisis

Cyberonics continued to track the VNS recipients, and two years later a third of patients in the original study had experienced some response and between 17 percent and 20 percent were in remission, Schultz said, evidence he ultimately found persuasive.

For Subscribers

FOR SUBSCRIBERSAbdul El-Sayed tries to woo MAHA voters as Democrats seek inroads with RFK’s supporters

FOR SUBSCRIBERSKratom-like substances are popping up in a typically benign supplement

FOR SUBSCRIBERSGOP super PAC increases its spending for Sen. Jon Husted in tough Ohio race

FOR SUBSCRIBERSRecords reveal tumultuous marriage between slain New York Times executive and wife

FOR SUBSCRIBERSFrom clean energy warrior to ‘wall of shame,’ James Talarico reverses on a fossil fuel money pledge

FOR SUBSCRIBERSCongressional staff planned official trip with luxury stops in Italy and France weeks before election

FOR SUBSCRIBERSA harrowing ordeal aboard an Israel-bound plane

FOR SUBSCRIBERSOpenAI CEO Sam Altman to skip congressional hearing on rogue AI agents

FOR SUBSCRIBERSKey DOJ lawyers departed Trump ‘grand conspiracy’ probe amid pressure to produce, source says

FOR SUBSCRIBERSTrump’s new AI chatbot often links to a site launched under Clinton 26 years ago

FOR SUBSCRIBERSAt MAHA summit, industry CEOs the movement once vilified take the stage

FOR SUBSCRIBERSThis Paralympian has two goals: Win medals and give away $500,000 to her teammates

FOR SUBSCRIBERSCornell rape allegation spotlights stringent New York state laws that have long drawn criticism

FOR SUBSCRIBERSThe debate over AI’s future rages on both coasts

FOR SUBSCRIBERSDecades-old march dispute reignites in Northern Ireland, threatening political crisis

Still, critics have complained that without a comparison group, it’s unclear if the implant really helped or the depression eased for some other reason.

Schultz said there are some safety warnings. The chief risk: More than half of patients in the depression study experienced at least temporary voice alterations — a hoarseness or raspiness, or voice “breaks” — that seem to persist in a significant number, he said.

Other complications include difficulty breathing or swallowing, he said. Deaths have been reported among some epilepsy patients who have a VNS implant, but Schultz said there was no sign of increased deaths in the depression study.