Navigation Links
New Studies Confirm Safety, Effectiveness of Balloon Sinuplasty(TM) Technology for Chronic Sinusitis
Date:9/21/2008

Patients show significant improvement through 2-year follow-up

MENLO PARK, Calif., Sept. 22 /PRNewswire/ -- Two multicenter studies published this week in Otolaryngology - Head and Neck Surgery confirm Balloon Sinuplasty(TM) technology is safe and effective when used by physicians to treat chronic sinusitis patients.

The foundation for those studies was a six-month clinical trial called CLEAR that began in 2005. It included 109 patients who had minimally invasive sinus surgery with the Balloon Sinuplasty(TM) technology. They participated in one-year and two-year follow-up studies which reported:

-- 92% functional patency at one-year follow-up.

-- At two-year follow-up, 85% of patients reported improvement in their

sinus symptoms. No patient's condition worsened.

-- Clinically and statistically significant improvements in patient

quality of life maintained at one and two year follow-up.

-- No serious adverse events observed at any time point throughout the

study.

Balloon Sinuplasty(TM) technology is used to restore normal sinus drainage by widening constricted sinus passages with specially designed catheters and balloons. The technology has been used to treat over 40,000 patients since receiving FDA clearance in 2005 and can be used alone or with standard surgical instrumentation.

The Center for Disease Control data reports sinusitis is among the most common illnesses in the U.S., affecting an estimated 37 million Americans and leading to 500,000 surgeries a year. Symptoms include repeated infections, headaches, facial pain, persistent congestion and unrelenting fatigue.

"The goal of sinus surgery is to open the sinuses so they can function normally, while preserving as much natural anatomy as possible. With Balloon Sinuplasty(TM) technology, we are able to accomplish that goal with our current approach in a true minimally invasive way, and give our patients the relief they have been seeking," said Frederick A. Kuhn, M.D. of the Georgia Nasal and Sinus Institute in Savannah, and lead author of the one-year outcomes study.

"These multi-year data continue to affirm the safety and effectiveness of Balloon Sinuplasty(TM) technology. Patients can feel confident that this technology truly provides significant, durable improvement in sinus symptoms and overall quality of life," said otolaryngologist Raymond Weiss, M.D. of the Sinus Center of the South in Biloxi, and lead author of the two-year study.

Recovery times vary after sinus surgery, but patients typically return to normal activities within 24 hours of treatment. Since 2005, more than 4,000 sinus surgeons have been trained to use Balloon Sinuplasty(TM) technology.

Bill Facteau, President and CEO of Acclarent, Inc. said, "We are very pleased with the 1- and 2-year results of the CLEAR Study. It is evident from these data that when Balloon Sinuplasty(TM) devices are used in sinus surgery they are safe, effective, and significantly improve a patient's quality of life."

About Acclarent

Acclarent, Inc. is a privately held medical device company located in Menlo Park, CA. 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 developing innovative technologies, and investing in clinical studies and physician training. For more information, visit http://www.acclarent.com or http://www.BalloonSinuplasty.com.


'/>"/>
SOURCE Acclarent, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. InNexus Lead Candidate DXL625 Outperforms Rituxan in Additional Animal Studies
2. Most Cancer Treatment Studies Arent Published, Study Finds
3. Bionovo Reports on Metabolic Studies Related to Its Menopausal Hot Flash Drug Candidate
4. Nutrition 21 Reports That National Toxicology Program Studies Support the Safety of Chromium Picolinate
5. Phase III Clinical Studies of Aclidinium Bromide Show Statistical Significance vs. Placebo in Patients With Chronic Obstructive Pulmonary Disease (COPD)
6. Catheter Ablation System for Atrial Fibrillation Shows Reduced Procedure Time, Remarkable Safety Profile and Excellent Outcomes in Two Clinical Studies
7. Genmab Announces Upcoming Ofatumumab Studies
8. Pooled-Analysis of 54 Clinical Studies Shows No Increased Risk of Heart Attack With Abacavir Therapy
9. Isolagen, Inc. Reports Positive Top-line Results from Pivotal Phase III Studies of Isolagen Therapy(TM) in Wrinkles: Studies Meet All Primary Efficacy Endpoints and are Statistically Significant
10. Treatment Corrects Severe Insulin Imbalance in Animal Studies
11. Video: Resveratrol-based Nutriceutical (Longevinex(R)) Induces Favorable Changes on Gene Expression in Mouse Heart At Doses 17-320 Times Lower Than Prior Studies
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... -- According to a new market research ... Safety Pen Needles), Needle Length (4mm, 5mm, 6mm, 8mm, ... Purchase (Retail, Non-Retail) - Trends & Global Forecasts to ... for the forecast period of 2016 to 2021. This ... 2021 from USD 1.65 Billion in 2016, growing at ...
(Date:6/24/2016)... , Belgium , June 24, ... VNRX), today announced the appointment of Dr. ... Directors as a Non-Executive Director, effective June 23, ... Audit, Compensation and Nominations and Governance Committees.  As ... Futcher will provide independent expertise and strategic counsel ...
(Date:6/23/2016)... 2016  MedSource announced today that it has ... solution of choice.  This latest decision demonstrates MedSource,s ... their clients by offering a state-of-the-art electronic data ... nowEDC as the EDC platform of choice in ... "nowEDC has long been a preferred EDC platform ...
Breaking Medicine Technology:
(Date:6/24/2016)... , ... June 24, 2016 , ... ... actively feeding the Frederick area economy by obtaining investment capital for emerging technology ... past 2½ years that have already resulted in more than a million dollars ...
(Date:6/24/2016)... ... June 24, 2016 , ... Today, ... stem (iPS) cells and other difficult to transfect cells, announces its launch of ... PluriQ™ G9™ Gene Editing System is a complete system for culturing and ...
(Date:6/24/2016)... ... 2016 , ... To succeed under value-based payments, healthcare providers ... how to move forward, given the need to sustain current operations. PYA has ... an organization’s specific needs. , PYA Principal Martie Ross states, “Healthcare providers want ...
(Date:6/24/2016)... ... 24, 2016 , ... SpiritQuest Sedona Retreats, located in Arizona has re-located to ... vortex sites: Cathedral Rock, Airport Mesa, and Boynton Canyon. The new retreat center ... as well as the Sedona Rouge, both popular accommodations for SpiritQuest clients. The ...
(Date:6/23/2016)... ... June 23, 2016 , ... An article published June 8 ... between head and neck cancer in individuals with unhealthy oral hygiene habits. The article ... on whether they had gum disease, brushed their teeth on a daily basis, wore ...
Breaking Medicine News(10 mins):