FDA clears device for resistant depression data analysis positive.

The Food and Drug Administration has cleared a noninvasive device that delivers magnetic stimulation to the brain for treating depression in adults, according to Neuronetics Inc., the manufacturer of the device.

The FDA cleared the NeuroStar TMS (Transcranial Magnetic Stimulation) Therapy System for treatment of major depressive disorder in adults who have failed to achieve satisfactory improvement from one prior antidepressant medication, used at or above the minimal effective dose and duration during the current episode, the company said in a statement.

The treatment is administered during a 40-minute outpatient procedure in the psychiatrist's office, typically every day for 4-6 weeks, as the patient sits in a chair that is part of the system. The device delivers MRI-strength magnetic pulses directed at the prefrontal cortex through a treatment coil, while the patient is awake and alert.

The company's statement summarizes a 6-week randomized, placebo-controlled, double-blind study of 164 patients with unipolar, nonpsychotic major depressive disorder (moderate to severe).

The primary end point--changes in the Montgomery-As-berg Depression Rating Scale symptom score at 4 weeks--was statistically significantly superior to placebo among those treated with the device, compared with those on placebo, according to the company.

In this and other studies, patients had no systemic side effects, no adverse effects on concentration or memory, and no seizures, and the discontinuation rate resulting from adverse events was less than 5%, the company said.

At a meeting in January 2007, the FDA's Neurological Devices Panel reviewed the device, agreed that the data presented by the company at that time did not show the treatment to be effective for depression, and recommended against approval. Several panelists said they believed there was a signal for effectiveness, and encouraged the company to continue pursuing studies of the device.

Originally, the company had filed a 510(k) premarket notification for clearance (not approval) of the device, which requires that a device be shown to be comparable with another device on the market, with the same intended use and evidence of a comparable risk-to-benefit profile, without directly comparing them. The company compared TMS with electroconvulsive therapy but the panel agreed that the TMS device could not be directly compared with ECT.

Subsequently, Neuronetics submitted a new data analysis, which found that a large group of patients showed a positive response to the treatment, a company spokesperson said. The device was reviewed and cleared for marketing under a mechanism for clearing devices with low risks, for which no predicate device has been identified, the spokesperson said.

The company is disclosing the price of the device only to prospective buyers.

BY ELIZABETH MECHCATIE Senior Writer