Acclarent, Inc. Launches Minimally-Invasive ACCLARENT AERA™ Eustachian Tube Balloon Dilation System In Europe
MENLO PARK, Calif., Sept. 18, 2014 /PRNewswire-USNewswire/ -- Acclarent, Inc. announced today the launch of the ACCLARENT AERA Eustachian Tube Balloon Dilation System for the treatment of adult patients with Eustachian Tube Dysfunction (ETD), a condition marked by ear pain, pressure and dulled hearing. The ACCLARENT AERA is cleared for use in Europe and is now available in Nordic countries.
The ACCLARENT AERA leverages the company's innovative balloon catheter technology and expertise to help physicians treat patients suffering from ETD. The ACCLARENT AERA System dilates an obstructed Eustachian tube by inserting a small balloon into the Eustachian tube and inflating the balloon. The balloon is then deflated and removed.
"The ACCLARENT AERA offers a minimally-invasive and promising option for patients suffering from Eustachian Tube Dysfunction," said Dr. Juha Silvola, MD, PhD, Consultant in Otology-Otoneurology at Rikshospitalet, Oslo University Hospital, Oslo, Norway. "In my initial experiences with the ACCLARENT AERA, the device enabled me to safely and successfully dilate my patients' Eustachian tubes."
ETD occurs when the Eustachian tube, a canal extending from the middle ear to the nasopharynx, cannot open properly. Patients with ETD often feel like their ears are perpetually clogged, deal with earaches, or experience impaired hearing. For many with ETD, this is a way of life and current treatment options may not resolve the problem, leaving patients and Ear, Nose and Throat (ENT) physicians frustrated. Current treatment options for ETD include medication and ear tubes, which may relieve symptoms. More invasive surgery may be necessary to address severe complications.
"Physicians and patients worldwide face many challenges in treating Eustachian Tube Dysfunction," said Dennis S. Poe, MD, associate professor of otology and laryngology at Boston Children's Hospital in Boston, Mass and co-primary investigator of the US-based clinical trial for the Eustachian Tube Balloon Dilation System. "ACCLARENT AERA may be a promising new option to fulfill an unmet need in the treatment of Eustachian Tube Dysfunction."
"Acclarent is excited to once again be at the forefront of enabling ENT surgeons to address patient needs by developing new and innovative technologies," said Bridget Ross, Worldwide President of Acclarent. "We are pleased to make the ACCLARENT AERA available to Nordic physicians, and are looking forward to expanding availability of the device to other regions in Europe and around the world."
About Eustachian Tube Dysfunction
A normal Eustachian tube helps regulate pressure in the ear. However, when the Eustachian tube is not functioning properly patients may feel a sense of fullness or clogging in their ear. The patient may also experience an earache, hearing loss or ringing in the ear. If the symptoms persist, the patient may develop a serious ear infection or develop long-term complications.
About Acclarent, Inc.
Acclarent, Inc., part of the Johnson & Johnson Family of Companies, is a medical device company located in Menlo Park, CA. Its singular focus is to free patients to live better lives by designing, developing and commercializing medical devices that address conditions affecting the ear, nose, and throat. For more than a decade, Acclarent has led the field in delivering innovative Balloon Sinuplasty technologies to ENT surgeons who manage patients with chronic sinusitis. For more information, visit www.acclarent.com.
(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995, including expectations regarding the ACCLARENT AERA. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Acclarent, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges inherent in new product development, including obtaining regulatory approvals; manufacturing difficulties and delays, internally or within the supply chain; challenges to patents; changes to regulations and domestic and foreign health care reforms; and general industry conditions, including trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 29, 2013, including in Exhibit 99 thereto, and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither Acclarent, Inc. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.)
The ACCLARENT AERA Eustachian Tube Balloon Dilation System is not for sale in the United States.
Dr. Poe is compensated by Acclarent, Inc. for his consulting services.
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SOURCE Acclarent, Inc.