In one study involving 72 adults, patients showed improvement in all six subscales of the Tonsil and Adenoid Health Status Instrument (TAHSI), a scale used to measure the quality of life (QOL) of patients pre- and post-procedure. Among the scale-related findings, 98 percent reported fewer infections in the six months following surgery, with 76.9 percent expressing strong satisfaction with the surgery results. Patients also reported substantially fewer cases of persistent bad breath (halitosis), sore throats, and trips to the doctor because of sore throats.

In the study involving children, 92 patients also showed significant improvements when measured with the same TAHSI scale, including airway and breathing, infection, health care utilization, cost of care, eating and swallowing, and behavior. Additionally, the Child Health Questionnaire-PF28 was used on 55 of the subjects in order to measure QOL with regards to general health, physical functioning, behavior, bodily pain, and parental impact. Among the study’s findings were significant decreases in number of sore throats, antibiotic courses, days missed from daycare/school, doctor visits, and persistent halitosis.

Tonsillectomy remains one of the most common procedures performed on children each year, and while the number of incidences in adults is lower, it is still a routine operation. The current clinical guidelines produced by the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS), which were developed using consensus of expert opinions, recommend tonsillectomy for children with three or more documented tonsil infections in the span of a year.

“Methods for Removing Bacterial Biofilms: In Vitro Study Using Clinical CRS Specimens,” led by Martin Desrosiers, M.D., associate clinical professor in the Department of Otolaryngology and Allergy at Montreal General Hospital, McGill University in Montreal, Canada, showed a large reduction of very robust and highly adherent bacterial colonies in a laboratory model. Two strains of bacteria, Pseudomonas aeruginosa and Staphylococcus aureus, were clinically isolated from CRS patients who had poor outcomes following functional endoscopic sinus surgery. Authors of the study, which was presented at the spring meeting of the American Rhinologic Society held last April in San Diego, Calif., received the ARS Basic Science Research Award.

The bacterial strains were grown into robust bacterial colonies and treated with a variety of commonly used therapies including antibiotics and hypertonic saline. These existing therapies were compared to static and pressurized application of a new irrigation solution under development at Medtronic (NYSE:MDT). Of the S aureus and Pseudomonas bacterial colonies grown in this model, respectively 99.98% and 99.999% of the bacteria were removed by the pressurized application.

Study Results Suggest Improved Efficacy in Bacterial Removal

Researchers at McGill University in Montreal, Montana State and at Medtronic collaborated to test the effectiveness of pressurized irrigation with the citric acid zwitterionic surfactant irrigating solution.

Bacteria isolated from failed surgical patients at McGill were sent to Montana State, grown into robust bacterial colonies, and treated with a number of static and dynamic irrigation solutions. Commonly used controls were compared to static and pressurized applications of the Medtronic surfactant. Control groups included many of the currently used irrigation solutions, containing antibiotics (tobramycin and doxycycline), and salt water (isotonic and hypertonic saline).

When applied statically, none of the controls had any material effect on the bacterial colony. Conversely, dynamic application of saline reduced the number of bacteria by 99.4% in both types of bacterial colonies. Static application of the surfactant reduced the number of bacteria in the colonies of S aureus and Pseudomonas 99.66% and 99.87% respectively. The best results were achieved when surfactant was applied under pressure, where 99.98% and 99.999% of S aureus and Pseudomonas were removed equaling a four- (10,000x) and five- (100,000x) log reduction, respectively.

“Given the positive results of this laboratory study, we are initiating a number of studies to further evaluate this technology,” said Bo Lewis, senior director of marketing for the ENT business at Medtronic. “Recent studies suggest that bacteria are much bigger players in the inflammation associated chronic sinusitis and chronic otitis media. We’re optimistic that, when commercialized, we will be able to improve the removal of bacteria during sinus surgery and ventilation tube surgery.”

Several living tissue and safety studies are scheduled to start in the near future with subsequent submission for review by the FDA.

About the ENT Business at Medtronic

Located in Jacksonville, Florida, the ENT business at Medtronic develops and manufactures products designed to treat ear, nose and throat (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, disposable fluid control products, image-guided surgery systems and a Ménière’s disease therapy device. Learn more about the ENT business on the web at http://www.MedtronicENT.com

About Medtronic

Medtronic, Inc., headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.

Previously, the U.S. Food and Drug Administration had granted Fast Track status to SybryxTM, acknowledging that chronic sinusitis that persists after sinus surgery has a serious and enduring adverse impact on the day-to-day functioning of patients who suffer from the condition. Moreover, there are no currently approved medical therapies for the treatment of chronic sinusitis, and the results of a previous Phase 2a trial demonstrated that SybryxTM relieved the symptoms of chronic sinusitis in post-surgical patients.

Robin Campbell, Ph.D., President and CEO of Naryx Pharma, stated, “We are pleased that we have completed this milestone in the development of SybryxTM and would like to thank all of the investigators who are participating in the trial. Many patients are suffering from chronic sinusitis, and we look forward to continuing to develop a treatment for this serious and sometimes debilitating disease.”

About Naryx Pharma

Naryx™ is a privately-held company dedicated to developing innovative therapies for chronic sinusitis, based on advances in the targeted delivery of medications. Chronic sinusitis is a disease that afflicts up to 35 million people in the U.S. alone. The Company will focus on obtaining marketing approvals for its promising intellectual property portfolio of intranasal drug formulations.

The authors explain that the removal of the tonsils (tonsillectomy), with or without adenoidectomy (removing the adenoids), is one of the most common surgical procedures performed on children. The frequency of tonsillectomies varies greatly from country-to-country. In 1998 115 per 10,000 Dutch children, 65 per 10,000 British children and 50 per 10,000 American children had an adenotonsillectomy (both adenoids and tonsils removed) – suggesting that in each country the indications for surgery are different.

Erik Buskens, M.D., Ph.D., University Medical Center Utrecht, Utrecht, the Netherlands, and team carried out a clinical trial with 300 children aged 2-8. They had all been recommended for adenotonsillectomy during 2000-2003. 151 children were randomly assigned to undergo surgery within six weeks, while the other 149 were assigned to watchful waiting. Watchful waiting means the patient is monitored closely and additional interventions are done as required. The parents kept diaries in which they logged data on their children’s upper respiratory tract symptoms, their daily temperatures, and recorded any costs associated with their care. There were follow-up visits after 3, 6, 12, 19 and 24 months.

During the 24 month period, the annual costs for the watchful waiting children were about $500 (€551, at 2002 exchange rate), while for the children who had had surgery the costs were $730 (€803) – 46% higher. The children who had undergone surgery experienced fewer fevers and throat infections. The researchers worked out that “The incremental costs per episode of fever, throat infection and respiratory tract infection avoided were €1,136 ($1,033), €1,187 ($1,079) and €465 ($423), respectively.”

The authors added “Overall, the balance between costs and effects in this population seemed unfavorable for adenotonsillectomy, with incremental cost-effectiveness ratios in excess of €465 ($423) per disease episode averted. Note that this estimate includes societal costs such as parental leave of absence associated with their child’s illness. Had these costs been left out of the equation, the figures would be even somewhat less favorable. With time, the child’s immune system matures and the difference in adverse episodes disappears. Thus, the initial cost increment in the adenotonsillectomy group will never be counterbalanced by a continued positive health effect.”

The researchers stressed that the cost effectiveness balance might be even less favorable in other countries – in the Netherlands, a relatively inexpensive procedure is used for adenotonsillectomy. It is possible, say the authors, that there may be children for whom surgery is cost-effective. Further research is needed to find out whether this is the case.

The study is the first of its kind to show greater efficacy of saline irrigation treatments versus saline spray for providing short-term relief of chronic nasal symptoms, the authors report. Participants in the study who were treated with irrigation experienced a much greater benefit than those who were treated with saline spray, in terms of both the severity and frequency of their symptoms.

“The irrigation group achieved a clinically significant improvement in quality of life in terms of the severity of their symptoms, whereas the spray group did not,” says lead author Melissa A. Pynnonen, M.D., clinical assistant professor in the U-M Department of Otolaryngology. “Strikingly, they also experienced 50 percent lower odds of frequent nasal symptoms compared with the spray group.”

The findings, which appear in the new issue of the Archives of Otolaryngology Head & Neck Surgery, could be significant for the multitudes of people who suffer from chronic nasal and sinus conditions. In the United States, 36 million people are affected by chronic rhinosinusitis each year, and millions more are affected by other types of allergic and non-allergic rhinitis.

Treatments including antibiotics, antihistamines and anti-inflammatory drugs can be helpful, but for many patients, symptoms persist. “A lot of symptoms still aren’t very well treated,” Pynnonen says.

Treatment with saline irrigations the flushing of nasal passages with a salt water mixture often is recommended by otolaryngologists (ear, nose and throat physicians) for a variety of sinus conditions. It has long been used as a treatment following sinus surgery, and more recently is becoming common in non-surgical patients. The authors of this study say their findings suggest that otolaryngologists and primary care physicians should recommend this treatment to their patients more often.

Saline sprays are often used as an alternative to irrigations because spray “is often perceived to be equivalent to and better tolerated than irrigation,” the researchers note. But the effectiveness of sprays has not been proven in clinical trials.

Among the 121 adults in this study all of whom have chronic nasal and sinus symptoms 60 were treated for eight weeks with saline irrigation and 61 were treated with saline spray. The severity of their symptoms was measured with the 20-Item Sino-Nasal Outcome Test, and the frequency of symptoms was measured with a questionnaire.

The irrigation group’s average score on the severity test had dropped (improved) by more points than the spray group’s average at intervals of two weeks, four weeks and eight weeks (4.4 points out of 100 lower at two weeks, 8.2 points lower at four weeks, and 6.4 points lower at eight weeks).

Frequency of symptoms also improved in both groups, though more for the irrigation group. While 61 percent of the spray group reported having symptoms “often or always” after the eight-week study, just 40 percent of the irrigation group did.

“It’s clear from our results that both treatments led to a decrease in frequency and severity of symptoms, but the difference is that the salt water flush led to substantial improvement,” Pynnonen says.

Both groups experienced adverse effects, with more reported in the irrigation group. Most were minor, however, and none required that the treatment be stopped. The most commonly reported adverse effect was post-treatment drainage.

“One of the greatest benefits of the nasal irrigation we are using is that it is very cheap and very safe,” Pynnonen says.

In addition to Pynnonen, authors of the study were Jeffrey E. Terrell, M.D. and Meredith E. Adams, M.D., of the U-M Department of Otolaryngology; H. Myra Kim, Sc.D., of the Department of Biostatistics and the Center for Statistical Consultation and Research at the U-M School of Public Health; and Shraddha S. Mukerji, M.D., of Texas Children’s Hospital.

Financial support was provided by NeilMed Pharmaceuticals, which had no role in design or conduct of the study; collection, management, analysis or interpretation of the data; or in the preparation, review or approval of the manuscript. NeilMed Pharmaceuticals manufactures Sinus Rinse, the saline product.