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Equipment and Supplies for VitalStim® Therapy

VitalStim® equipment best practices

NMES devices have been in routine use by rehabilitation professionals for a number of different indications for a long time. A multitude of different stimulators have received 510(k) clearance from the FDA over the years, usually for general indications such as pain relief and muscle strengthening. In 2002 the FDA cleared a modified NMES system comprising a device and electrodes, VitalStim® Therapy, for use for a very specific indication, oropharyngeal dysphagia, and in a very specific anatomical region, the anterior neck.

Devices

Unlike in other parts of the body, the use of NMES on the anterior neck has always received a WARNING label from the FDA, indicating that there is risk of serious injury or death when using general clearance NMES devices and supplies on the neck. The reason the FDA issues such strong language is because of unanimous warnings by authors and experts in the field of electrotherapy about the possibility of inadvertently triggering laryngospasm or bradycardia by stimulating the carotid sinus.

Use of NMES devices which have not been cleared for the treatment of dysphagia is contrary to that product’s labeling, is inconsistent with its intended uses, and is beyond the scope of applications implied.  Most NMES devices were primarily designed for use in the upper and lower extremities and do not incorporate the software and hardware modifications necessary to ensure safe application of electrotherapy to the anterior portion of the neck.

Implication for the clinician: Use of equipment in high risk anatomical regions such as the anterior neck requires specific clearance from the FDA; general clearance for neuromuscular stimulation/reeducation is not sufficient.

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VitalStim® Therapy clearance was obtained after a lengthy process in which FDA first required the manufacturer to submit data to demonstrate safety and efficacy. The FDA also required the manufacturer to submit evidence of design characteristics that would ensure safe and efficacious use of the device and the electrodes by future users (therapists).

Implication for the clinician: Only the VitalStim® Therapy device has successfully passed FDA scrutiny and received clearance for use on the anterior neck in the treatment of dysphagia. Deviation from the VitalStim® Therapy protocol by using a different device has not been cleared by the FDA for application on the anterior neck for the treatment of dysphagia.

Only clinicians who have successfully completed the VitalStim® Therapy Certification Course may administer VitalStim® therapy to patients.  Unlike other NMES devices and protocols, VitalStim® is not to be prescribed for independent use in the home by the patient.  

FDA Cleared Indication for Use

VitalStim® Therapy System (Device)

“Muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction”

The VitalStim® Therapy system is the only NMES-based dysphagia treatment to carry this clear and unambiguous indication for use from the FDA.

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VitalStim® Therapy Electrodes:  Impedance – 23ohms  

VitalStim Therapy protocol places a very high current load on the electrode. The electrodes used must be able to safely and consistently carry this current load without increasing in impedance which could jeopardize treatment outcomes.

  • Near continuous current delivery versus a 1:1 or even 1:2 duty cycle in typical NMES protocols
  • 0.8 inch diameter versus more typical 1 inch or greater
  • Long treatment duration of 60 minutes per session versus more typical 20-30 minutes
  • Electrodes manufactured in the United States
  • Developed specifically for the treatment of dysphagia; not sold for other uses. 

Implication for the clinician: Not all electrodes are created equal and are not interchangeable for therapy use. VitalStim electrodes are custom built for the VitalStim application and have been tested to perform well and consistently.

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