Study Shows Medtronic Microdebrider Turbinoplasty is a Significantly More Effective, Long-Term Treatment Than Coblation® Radiofrequency for Nasal Obstructions1

Medtronic (NYSE: MDT) announced today that results of a study published in the February issue of the Laryngoscope were favorable toward the use of Medtronic’s Straightshot^® M4 Microdebrider for powered inferior turbinoplasty. Written by Liu et al from Taipei Medical University, "Microdebrider-Assisted Versus Radiofrequency-Assisted Turbinoplasty,” states that patients treated with Medtronic’s microdebrider experienced significantly better long-term outcomes than those who received treatment with a Coblation^® radiofrequency device in what is the first three-year study directly comparing long-term efficacy of the two techniques.¹

"This study adds significant weight to the argument that RF treatments with Coblation aimed at the inferior turbinates are ineffective long term and put the patient’s nasal mucosa at risk,” says Scott Carpenter, senior product manager for ENT Powered Systems, part of the Surgical Technologies business at Medtronic.

In the study, 120 patients with chronic nasal obstruction and persistent allergic rhinitis unresponsive to medical treatment were randomly assigned to receive either microdebrider-assisted inferior turbinoplasty (MAIT) with the Medtronic device or radiofrequency-assisted inferior turbinoplasty (RAIT) with Coblation (ArthroCare Corporation). There were also 10 patients with no symptoms of nasal obstruction who served as normal controls. Patients were evaluated preoperatively and at six months and at one, two, and three years postoperatively using standardized measurements. These consisted of a visual analogue scale of 0 to 10 to gauge the patient’s subjective symptoms (nasal obstruction, rhinorrhea, sneezing, and snoring), active anterior rhinometry to measure total nasal resistance (obstruction), and saccharin testing to assess nasal mucociliary transport (how well the nasal mucosa are functioning by how long it takes for a patient to experience a sweet taste after a saccharin granule is placed in the nose).

The study found that, compared with preoperative findings, subjective and objective measurements in the MAIT group had improved significantly at all postoperative assessment times. In the RAIT group, significant improvements were observed at six months and one year, but not at two and three years. When results in the two groups were compared, none of the values for the assessed variables were significantly different at six months. At one, two, and three years, however, all results for both the subjective and objective variables were significantly better in the MAIT group. Neither group experienced significant complications from surgery.

The powered inferior turbinoplasty technique can be performed using the Medtronic Straightshot^® M4 Microdebrider and Inferior Turbinate Blade with patented elevator tip. Manufactured by the ENT business at Medtronic and available in the United States, this system features a tiny, rotating tip that allows the surgeon to remove tissue more precisely than traditional surgery tools. Using the Medtronic microdebrider, surgeons can remove enough tissue to correct the nasal obstruction and relieve the patient’s symptoms while preserving the mucous lining and normal turbinate function. Preservation of mucosa is considered an important factor in better postoperative outcomes in patients who have undergone nasal surgery.

The long-term results of this study are also supported by findings from Berger et al², Lee et al³, and Sacks et al. ⁴

"Because surgery is more invasive than medical treatment, it is important that surgery result in sustained improvements in the patient’s quality of life. Thus, we compared the long-term efficacies of the two surgical techniques,” writes Liu. "MAIT is more effective than RAIT for relieving nasal symptoms and decreasing total nasal resistance and saccharin transit time one to three years postoperatively in patients with persistent allergic rhinitis who have substantial nasal obstruction.”

Symptoms of nasal obstruction can be linked to multiple causes, of which deviations of the septum and inferior turbinate hypertrophy are the most common. Other techniques for reducing nasal obstruction symptoms may include complete or partial turbinectomy and septoplasty (straightening of the nasal septum). However, traditional treatment techniques, including manual instrumentation, radiofrequency energy and cauterization, have been linked to numerous complications, somewhat unpredictable outcomes, and high relapse rates. Learn more about nasal obstruction at www.ObstructedNose.com.

About the ENT Business at Medtronic

Located in Jacksonville, Florida, the Ear Nose and Throat (ENT) division at Medtronic develops and manufactures products designed to treat ENT diseases. As the market leader in ENT, Medtronic is changing the way ENT surgery is performed with innovative, minimally invasive products and techniques that benefit both patients and surgeons. Main products include powered tissue-removal systems and other microendoscopy instruments, nerve monitoring systems, sleep-disordered breathing therapies, image-guided surgery systems, disposable fluid control products, and a Ménière's disease therapy device. Learn more about the ENT business on the web at www.MedtronicENT.com

About Medtronic

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 24, 2009. Actual results may differ materially from anticipated results.

1. Liu C-M, Tan C-D, Lee F-P, Lin K-N, Huang H-M. Microdebrider-assisted versus radiofrequency-assisted inferior turbinoplasty. Laryngoscope 2009;119:414-8.

2. Berger G, Ophir D, Pitaro K, Landsberg R. Histopathological changes after Coblation inferior turbinate reduction. Arch Otolaryngol Head Neck Surg 2008;134:819-23.

3. Lee JY, Lee JD. Comparative study on the long-term effectiveness between coblation- and microdebrider-assisted partial turbinoplasty. Laryngoscope 2006;116:729-34.

4. Sacks R, Thornton MA, Boustred RN. Modified endoscopic turbinoplasty—long-term results compared to submucosal electrocautery and submucosal powered turbinoplasty. Presented at: American Rhinologic Society Spring Meeting; May 13-16, 2005; Boca Raton, FL.