Monthly Archives: July 2014

Medtech Winners of 2014

Medtech companies that have ever gone toe-to-toe with regulators let out a cheer this year when two from their ranks won significant battles versus FDA.

In June, Electromedical Products International Inc., a maker of cranial electrotherapy stimulation (CES) devices, prevailed in its nearly quarter-century campaign to convince FDA to down-classify CES devices from Class III to Class II.

Then, in September, the Washington DC Court of Appeals ruled in favor of the plaintiff in Ivy Sports v. Burwell. Ivy Sports had been fighting a decision by the agency to rescind market clearance for the Collagen Scaffold surgical mesh that forced its predecessor company, ReGen Biologics, into bankruptcy in 2011.

These David-versus-Goliath victories provided a welcome dose of schadenfreude to an industry often frustrated by FDA.

The Rise of Cranial Electrotherapy

Cranial Electrotherapy devices have been used in psychiatry practice for years.

Recently the FDA announced that it plans to approve cranial electrotherapy stimulation, the simple handheld medical device currently cleared to treat depression, anxiety, and insomnia. The FDA “has determined that there is sufficient information to establish special controls, and that these special controls, together with general controls, will provide a reasonable assurance of safety and effectiveness for CES devices.” In short, cranial electrotherapy will soon become the only medical device in the United States that is FDA-approved to treat insomnia and anxiety, and the only home-use device approved to treat depression. As such, it becomes part of the psychiatric armamentarium.

Used as an adjunct to drug therapy and other treatments, cranial electrotherapy is affordable without insurance and easy for patients to use without supervision. The cost ranges from $600 to $800, depending on the manufacturer and features. When used as an adjunct to antidepressants, medication dosages can be adjusted as clinically indicated according to symptoms and adverse effects. Cranial electrotherapy has been shown to attenuate methadone withdrawal and to improve cognitive function in chemically dependent patients.

The current indication language from the FDA does not specify a diagnosis, but the device is used for the symptomatic treatment of depression, anxiety, and insomnia. This fits with a patient-centered, empirical approach to treatment. This may fly counter to the prevailing DSM-5 culture, but aligns nicely with the realities of many psychiatric practices.

There is published research spanning over 40 years, with at least 20 double-blind placebo-controlled studies that prove benefit outweighs risk. Several studies suggest that cranial electrotherapy triggers changes in neurotransmitters and endorphin release.

read more – PsychiatricTimes