Often times when a patient suffers from vestibular (inner ear) vertigo, a condition characterized by a specific type of dizziness, they are told they must learn to live with it because it is too difficult to determine which ear is causing the problem.
Vesticon (Portland, Oregon) was founded in 2003 with the precise mission of achieving "victory over vertigo" and to get rid of the "learn to live with it" scenario that has become the standard prescription for these patients. In February the company launched its Epley Omniax system, a software-guided patient positioning system designed to help physicians and other care providers to accurately diagnose and effectively treat vestibular disorders including the most common type, known as benign paroxysmal positional vertigo (BPPV).
Cathy Epley, president/CEO and founder of Vesticon, told Medical Device Daily that most of the training for the physicians who treat vertigo is in surgery so most of the solutions that were available were surgical and they were incomplete solutions that were associated with a lot of side effects. Epley is the daughter of John Epley, MD, developer of the now-common "Epley Maneuver" for treating BPPV and the inventor of the Omniax.
"When Dr. Epley in the 1980s came up with this new way of treating vertigo it was revolutionary – I don't like to use words like that but he did change the existing theory on how to treat it and I think most people in the field would refer to it that way because he took away the need for surgery," Epley said. She was in the cardiology field and wrote grants to develop the technology for her father. When the Epleys got the grants, she licensed his technology and started the company.
The Omniax derives its name from the 360-degree multi-axial positioning it provides. According to Vesticon, the software-driven patient positioning system uses infrared goggles to assist caregivers in analyzing abnormal eye movement patterns that are associated with the shifting of loose particles in the inner-ear canals which cause BPPV. The system is unique, the company says, because it gives physicians and therapists the ability to rotate patients to virtually any position, including a 360-degree flip. The science behind the system is derived from Dr. Epley's "paradigm-shifting work" in the vestibular field, Vesticon said.
The Trinity Hearing & Balance Center (Trinity, Florida), an audiology center focused on treating dizziness and balance disorders, recently became one of just a handful of clinics to offer the technology since its commercial launch earlier this year. Trinity says it will have "much greater success identifying and treating the causes of dizziness" now that it has the Omniax.
"Too often, the current standard of care comes up short and patients are told they must live with their condition," said Kelly Hansen, MD, founder of Trinity Hearing & Balance Center, in a statement. "Now that we have the Omniax in place, the vast majority of those cases can be resolved."
Hansen, an audiologist of 18 years, says her main purpose for opening the practice was to provide a "state-of-the-art" facility for diagnosing and treating dizziness and balance disorders.
"Now I use the Omniax with every dizzy patient I treat," Hansen said. "Here's why: with one recent patient at another office where I sometimes fill in, I performed a table maneuver twice without success. The third time I suggested she come to my office where I could use the Omniax. After one treatment on the Omniax, she was completely fixed. Of course, she was thrilled and so was I."
According to Vesticon, the Omniax is the first device to offer precise nystagmus-based evaluation. "It provides caregivers unmatched ability to detect, differentiate, treat and manage balance and dizziness disorders," the company said. Until now, BPPV diagnosis and treatment has involved a significant amount of educated guesswork and, if it is BPPV, manual maneuvers which tend to be both difficult to accomplish and imprecise, Vesticon said. When BPPV is diagnosed, the current standard of care is to perform the Epley Maneuver manually, the company noted.
Epley said that balance disorders often involve loose particles (calcium stones or crystals) in more than one inner ear canal, or particles in a canal other than the posterior canal. Occasionally the problem is caused by some other issue, such as damage to the brain or a problem elsewhere in the ear, she said.
The treatment for BPPV is usually moving the patient around to maneuver the loose particles out of the canals and into an area of the ear that will not be irritated, Epley said. She compared the process to getting a rabbit down into its hole.
Epley said the emerging literature shows that the other canals are much more frequently where the problem is and she says the company is getting information on the Omniax to support that. To explain the importance of this new literature and why the system is so important to the diagnoses and treatment of this condition, Epley said it would be like a cardiologist treating heart attack patients by always only treating the left ventricle, instead of finding out what part of the heart actually needs treatment. "Maybe 50% of the time you'd hit it and the other 50% you'd miss," she said.
Or, for another way of looking at it, she said it would be like "kicking the pop machine."
"If you don't monitor the eyes and understand eye patterns you're kicking the pop machine and hoping that what you're doing works," Epley said. "It's wasting the level of science in our field, which is an undeveloped area compared to something like cardiology."
With the Omniax system, a physician can now rule in or rule out various causes of vestibular vertigo and if it is determined that the cause is particles in the ear canal, the system provides a means to more easily and more effectively treat it, according to Vesticon.
Research for the company's products currently in development has been "generously" supported by the National Institutes of Health Small Business Innovation Program, Vesticon noted. The Omniax was the first of the company's products to gain FDA approval.
"Previously, much of our energy went into holding the patient in place and safely maneuvering the patient, which can be quite difficult when the individual is frail or heavy or experiencing nausea," Hansen said. "With the Omniax, my patients are securely held in the exact position required and I can concentrate on watching the eye movements."