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

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Wed Jun 24, 2009 9:00am EDT

MINNEAPOLIS--(Business Wire)--
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. 





Medtronic, Inc.
Jeff Warren, 763-505-2696
Investor Relations
or
Chuck Grothaus, 763-505-2614
Public Relations


Copyright Business Wire 2009

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