Results of a two-year follow-up study show that about two-thirds of Meniere's disease patients who are unresponsive to traditional medical treatment experience a "significant, long-term reduction" in vertigo frequency using a Medtronic (Minneapolis) device specifically designed for this purpose, called the Meniett Low-Pressure Pulse Generator.
The study results, the latest of a series of studies undertaken on the device, were published in the December issue of the Archives of Otolaryngology-Head and Neck Surgery.
"We've spent a lot of our efforts getting clinical work done, because I think the proof has to be there from a scientific point," Tino Schuler, senior director of marketing-otology for Medtronic at its Jacksonville, Florida, ENT site, told Medical Device Daily.
Schuler said that without scientific credibility, a device like Medtronic's could get "lumped in" with the variety of other treatments that people seek out in an effort to address the symptoms of Meniere's disease, which is characterized by vertigo primarily, but also hearing loss, tinnitus and pressure in the ear.
There is no known origin for the disease, and there is no cure — only potential treatments, or, as Schuler noted, treatments that are "just a matter of controlling symptoms."
Medtronic said that about 2.6 million people in the U.S. and Europe have the disease, which originates with excess fluid in the ear. Because the primary symptom of the disease is vertigo — which can be debilitating to the point of people being unable to work or conduct other everyday activities — that is the symptom that the company's Meniett device is designed to alleviate.
Medtronic acquired the device from a Swedish company, and it secured FDA approval for the product in December 2001.
The Meniett device and treatment, which is self-administered, is designed to deliver low-pressure air pulses through a tube, which remains in the ear, and is then connected to an earpiece placed in the outer ear. The tube in the inner ear is surgically implanted.
Medtronic said it is thought that the device's method of action is that the low-pressure pulses displace the excess inner ear fluid and therefore normalize the pressure in the ear, decreasing the effects of vertigo. The device, which can be battery-operated or used with an electrical outlet, essentially compresses air to deliver the pulses, but they are regulated through computer-controlled algorithms to deliver the air pressure at specific frequency and pressure.
The company also states on its web site devoted to the Meniett device that this reduction of inner ear fluid is thought to be a result of "both mechanical and chemical processes."
The device is only available by prescription from physicians, who "typically" prescribe three treatments per day, each treatment taking about 5 minutes.
Other treatments for Meniere's disease range from medication to surgery, according to Medtronic, which states that "medical therapy" successfully alleviates symptoms in about 70% of patients.
That therapy includes such things as a low-sodium diet, avoidance of caffeine, nicotine and alcohol and diuretic treatment. Such therapy also may include other medications, such as steroids, anti-depressants, antihistamines and vasoactive drugs.
The study was an unblinded, two-year follow-up to a previous randomized, placebo-controlled, double-blind, multi-center trial of therapy using the Meniett. The results included those from 58 of the 62 people in the original trial, which was conducted in 2004.
Participants in the follow-up study were asked to adhere to a low-sodium diet and use the Meniett device three times a day, according the study protocol. Diuretics and vestibular suppressant medications were used as needed, the study report says.
Patients were also asked to — and agreed to — use the device as prescribed and report their symptoms for two years. The patients were followed remotely via daily diaries, questionnaires and telephone interviews.
According to the study, vertigo levels gradually improved for most but not all participants.
American Academy of Otolaryngology-Head and Neck Surgery Foundation class A (suggesting remission) or class B (suggesting greatly improved) results occurred in 67% of participants. Those participants who did achieve remission of symptoms were determined to be highly likely to remain in remission long-term.
Of those participating, 24% dropped out to receive surgical therapy.
Employing its own strategy of social marketing, Medtronic has a web site for patients who suffer from the disease, at www.meniett.com. The cite discusses the symptoms and treatment options for the disease, as well as patient stories from those who have the disease.
"We've really tried to make that a patient education web site rather than a device web site …" Schuler said.