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Recent News and Articles on the Keywords: safe + study + sinuplasty  Related to the article below (Last Update: 8/5/2008)

Growth Hormone Reduces Abdominal Fat, Cardiovascular Risk In HIV ...
Science Daily (press release) -
The study from researchers at Massachusetts General Hospital (MGH) appears in the Aug.. 6 Journal of the American Medical Association, a special issue on ...
Treatment With Anti-anemia Drugs May Not Be Safe For Multiple ...
Science Daily (press release) -
4, 2008) ? A recent study published in American Journal of Hematology demonstrated that Erythropoiesis-stimulating agents (ESAs), a widely used drug to ...
Immunotherapy Boosts Treatment of Kids' High-Risk Sarcomas
Washington Post, United States -
"This study shows that immunotherapy is safe and well-tolerated, and could ultimately be beneficial for this high risk population," she said in an American ...
Keep safe sites open, court urged
Independent Online, South Africa -
The Pretoria High Court has been asked to order that the temporary safe sites set up for refugees after xenophobic violence be kept open until their charges ...
Courts to decide xenos? fate Citizen
'No need for court action on shelters' Independent Online
all 45 news articles »
Ginseng Safe for Short-Term Pediatric Use
MedPage Today, NJ -
4 -- Ginseng appears safe for treating children with cold and flu symptoms, researchers here found. Explain to interested patients that the study looked ...

Washington Times
Immigrants kids even less active than US-born
The Associated Press -
CHICAGO (AP) ? Many immigrant children get even less vigorous exercise than their US-born counterparts, the largest study of its kind suggests. ...
Immigrant kids less active than American-born kids WLNS
all 283 news articles »
Poll shows Utahns want "safe food supply"
Daily Herald, UT -
There is no comprehensive study about how much farmland has been lost to development along the Wasatch Front, but "generally we're losing the prime farmland ...
Pharmasset Reports Preliminary Results of a 4-week Combination ...
CNNMoney.com (press release) - 17 minutes ago
As previously reported for Cohorts 1 and 2 of this study, R7128 has demonstrated potent short-term antiviral activity and was generally safe and well ...VRUS
Parents think like tots, hire pros to fix home hazards
Detroit Free Press, United States -
The rate of death from such injuries in the US dropped 45% from 1987 to 2005, according to a study by Washington-based Safe Kids Worldwide, an organization ...
Toxics found in laundry products, air fresheners
Seattle Post Intelligencer -
Six laundry products and air fresheners tested in a University of Washington study gave off at least one chemical regulated as toxic or hazardous under ...
Source: Google News

Balloon sinuplasty: a current hot topic in rhinology -
JK Siow, BA Kadah, JA Werner - European Archives of Oto-Rhino-Laryngology, 2008 - Springer
... A study by Brown and Bolger [2] regarding the ... the Caldwell Luc procedure; then, balloon
sinuplasty may be ... of the paranasal sinus, which is safe, which bleeds ...
-

08: 10 AM Safety and Efficacy of Balloon Catheter Sinus Ostia Dilation
WE Bolger, CL Brown, CA Church, AN Goldberg, B … - Otolaryngology-Head and Neck Surgery, 2006 - Elsevier
... The aims of the present study were to confirm ... endoscopic sinus surgery was recommended
were offered sinuplasty. ... technology appears to be a safe and effective ...

[PDF] Scanning the Horizon -
F Closure - cadth.ca
... Safe Angle 2004;5-7. Available:http:// www.hchsa.on ... In a small feasibility pilot
study,no adverse events ... outcomes six months after balloon sinuplasty surgery in ...

Truths and Clarifications from a Company Trying to Make a Difference in ENT
A Options, TOC Latest - American Journal of Rhinology, 2007 - ingentaconnect.com
... in introducing the novel Balloon Sinuplasty Technology into ... manner to facilitate
their safe and effective ... an initial safety and feasibility study in cadavers, ...

Safety and outcomes of balloon catheter sinusotomy: A multicenter 24-week analysis in 115 patients -
WE Bolger, CL Brown, CA Church, AN Goldberg, B … - Otolaryngology-Head and Neck Surgery, 2007 - Elsevier
... Is it safe? ... influence from an individual practice pattern on the overall study results.
Balloon sinuplasty is new and many studies with various designs will be ...

[PDF] The State of the Art of Image-Guided Surgery
WSIGSB Used - entoday.com
... patients,and what you feel is safe,? said Sanjay ... microdebriders and drills, sinuplasty
bal- loons, and frontal sinus and ... Dr. Batra cited a study from the Uni ...
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Pediatric Sinusitis, Medical Treatment
HH Ramadan, U Viral - emedicine.com
... Balloon sinuplasty. This new procedure should be considered ... Pregnancy, B - Usually
safe but benefits must outweigh the ... a CT scan with contrast study to determine ...
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An Integrated Approach to Frontal Sinus Surgery -
FA Kuhn - Otolaryngologic Clinics of North America, 2006 - Elsevier
... Endoscopic frontal sinuplasty. ... Siller's study provided surgeons with the ability
to obtain sagittal sinus CT reconstructions and thin axial sections for ...

Who is Responsible for Evaluating the Safety and Effectiveness of Medical Devices? The Role of … -
MD Feldman, AJ Petersen, LS Karliner, JA Tice - Journal of General Internal Medicine, 2008 - Springer
... FDA approval can help identify those medical technologies that are truly beneficial
and safe. ... This study was funded by the Blue Shield of California Foundation ...

[PDF] Dr. Michael ME Johns: A Statesman of Our Time
L Learning - entoday.com
... tions on rhinoplasty and intensively study- ing the ... and what you feel is safe,? said
Sanjay ... microdebriders and drills, sinuplasty bal- loons, and frontal ...
-

Source: Google Scholar

Study Confirms Balloon Sinuplasty(TM) Technology Is Safe And Effective For Chronic Sinusitis Patients
An international, multi-center study of 109 patients confirmed Balloon Sinuplasty(TM) Instruments are safe and effective for opening blocked sinuses. Patients who participated in the study experienced significant relief from their symptoms associated with chronic sinusitis. Peer reviewed data published in the July 2007 issue of the prestigious journal "Otolaryngology-Head and Neck Surgery" showed 97% of the blocked sinuses were successfully opened with the technology. There were no adverse events and the treated sinuses showed remarkable patency throughout the study.
Chronic sinusitis is an inflammation of the nasal sinuses that afflicts an estimated 37 million Americans annually. Symptoms can be debilitating and include nasal discharge, sleep depravation, fatigue, headaches, facial pain, and chronic obstruction. Although antibiotics and topical steroids help most people, approximately 500,000 patients in the U.S. undergo surgery each year using a procedure called Functional Endoscopic Sinus Surgery (FESS). In a FESS procedure, a physician uses a small endoscope to see inside the nasal anatomy, and specialized surgical instruments to remove bone and tissue to enlarge the sinus openings.

Balloon Sinuplasty(TM) Instruments first received FDA clearance in December 2004. Unlike standard instruments for sinus surgery, these devices do not require any cutting or tissue removal. Similar in concept to catheters used in the heart for balloon angioplasty, Balloon Sinuplasty(TM) instruments can be threaded into small sinus passageways and then enlarged, thereby widening the passages to promote drainage and resolution of chronic sinusitis symptoms. These minimally invasive instruments are custom designed to work within the intricate sinus anatomy and can be used alone or in concert with standard surgical instruments during sinus surgery.

Recovery times vary but some patients return to normal activities within 24 hours of surgery. To date, more than 1,300 sinus surgeons have completed Acclarent's training program on the use of this technology and more than 10,000 patients have been treated across the United States.

"The results from this multi-center study indicate that balloon catheter technology has an excellent safety profile and is an effective minimally invasive treatment option to relieve sinus ostial obstruction. Surgeons typically use tissue-cutting forceps and tissue shavers or microdebriders to open sinuses. Now surgeons have another instrument that allows them to relieve sinus obstruction by dilating rather than cutting," said lead author William Bolger, M.D., of the Maryland Sinus Center in Baltimore. "An important concern for surgeons trying new technology is the ability to achieve good results without introducing complications. We know that complications occur more frequently during the initial adoption period. However, this investigation indicates that serious complications related to the devices don't appear to accompany initial adoption."
The catheter-based Balloon Sinuplasty(TM) technology, developed and produced by Acclarent, Inc. of Menlo Park, California, was conceived by physician, engineer and chronic sinusitis sufferer Joshua Makower, M.D. Dr. Makower was successfully treated with his invention this May.

"I feel very confident in these data since 90% of the patients enrolled in the study returned for follow-up and showed significant benefit and improvement. This is one of the most comprehensive studies ever conducted in sinus surgery," said Fred Kuhn, M.D., founder of the Georgia Nasal & Sinus Institute in Savannah and past president of the American Rhinologic Society. "I consider balloon dilation of the sinus openings a major advancement in the treatment of chronic sinusitis."

A large percentage of chronic sinusitis is related to obstruction associated with swollen and inflamed membranes along the sinus passageways. Normally, the sinuses can produce up to a quart of mucous a day. When the sinuses are blocked, they can't drain properly and the retained fluids can become infected. Balloon Sinuplasty(TM) devices gently restructure the bones lining the sinus passageways, permanently widening the opening and allowing for drainage and restoration of normal function.

"I would like to thank all the investigators for their contributions to this groundbreaking trial," said Bill Facteau, President and CEO of Acclarent, Inc. "This is an important study that will be referenced for many years to come. As excited as we are with these results, even more gratifying are the outcomes of the now more than 10,000 patients that have been successfully treated since this watershed study was completed. We remain excited about the opportunity to bring this and many more innovative technologies forward to ENT surgeons and their patients in the months and years ahead."

About Acclarent

Acclarent, Inc. is a privately held medical device company in Menlo Park, CA that was established in June of 2004. Its singular focus is improving patient care in all areas of otolaryngology by developing and producing medical devices solely for Ear, Nose and Throat (ENT) specialists and their patients. Acclarent is demonstrating this by investing in innovative technologies, clinical studies, and physician training. For more information, visit http://www.acclarent.com.

Acclarent, Inc.
http://www.acclarent.com
 
 
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