Study Offers Hope of Long-Term Vertigo Relief for Meniere’s Disease Patients
Medtronic Device Enables Significant, Long-Term Reduction in Frequency of Vertigo1
MINNEAPOLIS – January 3, 2007 – Medtronic (NYSE: MDT) announced today that results of a two-year follow-up study published in the December issue of the Archives of Otolaryngology–Head and Neck Surgery were favorable toward long-term use of Medtronic’s Meniett® Low-Pressure Pulse Generator for Ménière’s disease. The study concludes that approximately two-thirds of Ménière’s disease patients who are unresponsive to traditional medical treatment experience a significant, long-term reduction in vertigo frequency with Meniett therapy.
Approximately 2.6 million people in the US and Europe2 suffer from Ménière’s disease, a disorder associated with excess fluid in the inner ear. This complex disease is characterized by vertigo in combination with hearing loss, tinnitus (ringing in the ear) and pressure in the ear. The origin is unknown and there is no cure, which makes managing the disease difficult when symptoms are severe. Unpredictable vertigo attacks with nausea and vomiting can be very debilitating, with patients unable to work or perform routine activities.3
“Use of the Meniett device was associated with a significant reduction in vertigo frequency in about two thirds of the participants, and this improvement was maintained long term,” writes Dr. George Gates, department of Otolaryngology–Head and Neck Surgery at the University of Washington School of Medicine and the Virginia Merrill Bloedel Hearing Research Center. “Therapy with the Meniett device is a safe and effective option for people with substantial vertigo uncontrolled by medical therapy.”
This study is an unblinded, two-year follow-up to a previous randomized, placebo-controlled, double-blind, multicenter clinical trial of Meniett therapy for Ménière’s disease.4 Results were reported for 58 of the 62 people in the original trial (2004), who agreed to use Meniett therapy and relay their symptoms for two years. These patients were followed remotely via daily diaries, questionnaires, and telephone interviews. Patients were instructed to maintain a low-sodium diet, self-administer the Meniett treatment three times per day, and ensure that the ventilation tube in the affected ear (necessary for the treatment to reach the inner ear) remained open. Study participants were permitted to use diuretics and vestibular suppressants as needed, although medications had not proven successful in managing the disease in these patients prior to their use of the Meniett. There were no adverse events reported during the two-year follow-up.
Prior to the Meniett device, individuals whose symptoms did not improve with medical therapy had very few treatment options. Patients could either hope that their symptoms would eventually improve or resort to surgical methods that offered only varying rates of success. The Meniett gives patients a way to manage the disease without undergoing more invasive surgeries.
How the Meniett Device Works
Manufactured by the ENT division of Medtronic, the Meniett device delivers low-pressure air pulses through a tube connected to an earpiece placed in the outer ear. It is believed that the low-pressure pulses displace the excess inner ear fluid, normalizing the pressure within the ear and helping to relieve the symptoms of Ménière’s disease. Available by prescription only, the small device is easy for patients to use and self-administer treatment at home or work. Physicians typically prescribe three treatments per day, and each treatment takes around five minutes.
About the ENT Business at Medtronic
Located in Jacksonville, Fla., the ENT business at Medtronic (www.MedtronicENT.com) is a leading developer and manufacturer of products to treat diseases of the ear, nose and throat (ENT). Patients seeking additional information about Ménière’s disease and the Meniett device should visit www.meniett.com.
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s Annual Report on Form 10-K for the year ended April 28, 2006. Actual results may differ materially from anticipated results.
1. Gates GA, Verrall A, Green, Jr. JD, Tucci DL, Telian SA. Meniett clinical trial: long-term follow-up. Arch Otolaryngol Head Neck Surg. 2006;132:1311-1316.
2. Stahle J, Stahle C, Arenberg IK. The incidence of Ménière’s disease. Arch Otolaryngol Head Neck Surg. 1978;104:99-102.
3. Anderson JP and Harris JP. Impact of Ménière’s disease on quality of life. Otol Neurotol. 2001;22:888-894.
4. Gates GA, Green, Jr. JD, Tucci DL, Telian SA. 2004. The effects of transtympanic micropressure treatment in people with unilateral Ménière’s Disease. Arch Otolaryngol Head Neck Surg. 2004;130:718-725.
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