Source: Reuters.com
Author: Staff

Published Study Demonstrates Effectiveness of VitalStim Therapy for Patients Suffering with Dysphagia

A recent study published in the April 2008 issue of the Annals of
Otology, Rhinology & Laryngology has revealed the positive clinical
effect of the adjunctive use of VitalStim(R) Therapy. A leading brand
within the Empi Recovery Sciences line of pain management and
rehabilitation products, VitalStim is a non-invasive neuromuscular
electrical stimulation (NMES) device for the treatment of dysphagia.
Results of the study were also originally presented at the American
Association of Speech-Language Pathology Conference in Miami, Fla. in
November 2006.

Dysphagia, or difficulty swallowing, is a sorely neglected medical
condition which affects 15 million Americans and is generally caused
by a neurological disorder or event, such as a stroke, degenerative
neurological diseases and head and neck cancer. Without proper
management, dysphagia can lead to aspiration, pneumonia, choking,
chronic malnutrition, severe life-threatening dehydration, an
increased rate of infection, longer hospital stays, long-term
institutional care and even death.

VitalStim Therapy is a non-invasive external electrical
stimulation therapy that was cleared to market by the FDA in December
2002. VitalStim is a portable, dual-channel electrotherapy system that
is used with electrodes specifically designed for application to the
muscles of the throat to promote swallowing.

Entitled “Adjunctive Neuromuscular Electrical Stimulation for
Treatment-Refractory Dysphagia,” the study details the measured
clinical effect of the VitalStim program on six patients with chronic,
treatment-refractive dysphagia. The study describes a prospective case
series using validated outcome measures to represent different domains
and a standard program of dysphagia therapy, which includes a
consistent application of NMES following VitalStim Therapy protocol.

Patients received an average of 12 treatment sessions throughout
the study. Following the treatment, patient measurements demonstrated
key findings, including:

— 80 percent of patients reached the defined primary end-point
of clinical improvement in swallowing ability, with
significant Mann Assessment of Swallowing Ability (MASA) score
improvements;

— All patients in the study significantly increased the range
and amount of materials consumed orally – 83 percent of the
patients increased their Functional Oral Intake (FOIS) score
by at least two scale points, with most of the patients
progressing from a restricted, single-consistency diet to a
full oral diet;

— The average weight gain for the group over the three-week
treatment period was two pounds;

— Patients involved in the study perceived significant
improvement in their ability to swallow after treatment – no
patient rated their post-therapy swallowing ability as lower
than their baseline score;

— No patient experienced any swallowing-related medical
complication over the treatment period.

The study was led by Giselle D. Carnaby-Mann, MPH, Ph.D.,
associate research scientist in the Department of Behavioral Science
and Community Health at the University of Florida, and Michael A.
Crary, Ph.D., professor in the Department of Communicative Disorders
at the University of Florida. In addition, both are co-directors of
the Swallowing Research Laboratory at the University of Florida.

Six months following completion of the treatment period, four of
the patients completing the protocol returned for a medical review.
Post-treatment examinations showed no statistically significant
changes in clinical outcome measures, showing sustained efficacy after
cessation of treatment.

For more information, please visit
www.vitalstimtherapy.com/research.

About Empi, Inc.

Headquartered in St. Paul, Minnesota, Empi is a leading
manufacturer and provider of non-invasive medical products for pain
management and physical rehabilitation. Empi is committed to
delivering positive patient outcomes and providing innovative products
specifically designed to meet the needs of the patient, medical
professional, and payor. For additional information on the company,
please visit www.empi.com. Empi is a DJO company.

About DJO Incorporated

DJO is a leading global developer, manufacturer and distributor of
high-quality medical devices that provide solutions for
musculoskeletal health, vascular health and pain management. The
Company’s products address the continuum of patient care from injury
prevention to rehabilitation after surgery, injury or from
degenerative disease. Our products are used by orthopedic specialists,
spine surgeons, primary care physicians, pain management specialists,
physical therapists, podiatrists, chiropractors, athletic trainers and
other healthcare professionals. In addition, many of the Company’s
medical devices and related accessories are used by athletes and
patients for injury prevention and at-home physical therapy treatment.
The Company’s product lines include rigid and soft orthopedic bracing,
hot and cold therapy, bone growth stimulators, vascular systems,
electrical stimulators used for pain management and physical therapy
products. The Company’s surgical division offers a comprehensive suite
of reconstructive joint products for the hip, knee and shoulder. DJO’s
products are marketed under the brands Aircast(R), DonJoy(R),
ProCare(R), CMF(TM), Empi(R), Saunders(R), Chattanooga Group(TM), DJO
Surgical, Cefar(R)-Compex(R) and Ormed(R). For additional information
on the Company, please visit www.DJOglobal.com.

Empi, Inc.
Sara Oxton, 651-415-7479
Senior Brand Manager
[email protected]
or
Lois Paul & Partners
Susan Lombardo, 781-782-5767
Account Manager
[email protected]

Copyright Business Wire 2008