September 22, 2008
Entellus Medical(R) Launches FinESS(TM) Sinus Treatment at American Academy of Otolaryngology (AAO) Annual Meeting
Entellus Medical, a Minnesota-based medical technology company, today announced the launch of its FinESS Sinus Treatment, a less-invasive and effective treatment for chronic rhinosinusitis (CRS), during the American Academy of Otolaryngology Annual Meeting in Chicago September 21-24. Results of the BREATHE I clinical study validating the FinESS treatment were presented to members of the American Rhinologic Society (ARS) during its annual meeting in Chicago on September 20.
FinESS Sinus Treatment, which received FDA clearance in April 2008, is the direct and simple approach to effectively treat chronic rhinosinusitis. The FinESS Sinus Treatment eliminates the need for general anesthesia and results in minimal pain and bleeding. CRS affects more than 35 million people in the U.S. and results in more than 500,000 surgeries annually. FinESS is recommended for patients with common forms of chronic rhinosinusitis who do not respond to medical therapy."The impetus behind FinESS was the need for a new CRS treatment for ENT physicians and their patients that is less invasive, reduces pain and bleeding, shortens treatment and recovery time, and eliminates the need for general anesthesia," said Thomas Ressemann, president and CEO of Entellus. "Based on these opportunities the long term focus with the FinESS Treatment is to provide a cost-effective technology which can be used in the office setting."
Preliminary BREATHE I Clinical Study Results Validate Effectiveness of FinESS
Interim results of the BREATHE I (Balloon Remodeling Antrostomy THErapy) clinical study were presented to members of the American Rhinologic Society (ARS) during its Fall Meeting in Chicago on Saturday, September 20 by James Stankiewicz, M.D., Professor and Chairman, Department of Otolaryngology - Head and Neck Surgery at Loyola University Medical Center in Chicago, IL. BREATHE I is a prospective, non-randomized, multi-center study designed to enroll a maximum of 100 subjects. The objectives of the study are to evaluate the safety and effectiveness of Entellus Medical's FinESS system in treating subjects with CRS in the maxillary or maxillary plus anterior ethmoid sinuses. This study will also assess the feasibility of performing the FinESS treatment using local anesthesia only and treating patients in the physician's office.
Stankiewicz, et al. concluded that the BREATHE I study showed statistically significant, sustained, symptomatic improvement in SNOT 20 (validated quality of life questionnaire) scores through 6 months. The study demonstrated that direct access and balloon dilation of the maxillary sinus ostia and ethmoid infundibulum under local anesthesia can be performed with little pain or bleeding and patients resume normal activity within 1-2 days.
"The BREATHE I study supports that patients with chronic sinusitis can benefit from this less invasive treatment," said Stankiewicz. "The opportunity for these patients to be treated using local anesthesia, recuperate quickly, and receive this approach in the physician's office setting, are important benefits."
How FinESS Works
FinESS is a less-invasive option for treating CRS. It is a simple endoscopic treatment performed under local anesthesia with or without light sedation that remodels the maxillary ostium and ethmoid infundibulum using familiar tools - a small balloon catheter and a micro endoscope for visualization. Unlike sinus surgery techniques, FinESS does not require the removal of delicate bone or sinus tissue because it enables direct access to the affected sinus through a small entry point under the lip using a micro-trocar.
This less-invasive approach eliminates the need for general anesthesia and fluoroscopy, results in less bleeding and pain for the patient, and shortens treatment time. Recovery time is usually one to two days with many patients resuming normal activity within hours.
Long term, Entellus Medical is focused on working with payers to ensure coverage and payment for the FinESS Sinus Treatment when treating patients in the physician's office setting.
Entellus Medical was founded in 2006 by seasoned medical device innovators, Thomas Ressemann, Peter Keith, and ENT surgeon Theodore Truitt, M.D. Entellus recently secured $15 million in Series C Financing to commercialize FinESS sinus treatment technology.
About Entellus Medical(R):
Founded in 2006, Entellus Medical is focused on providing unique solutions to address the unmet needs of ENT (ear, nose, and throat) physicians, their patients, and payers through the development of innovative device technology and treatment. Based in Maple Grove, Minn., Entellus Medical recently introduced FinESS(TM) Sinus Treatment, a simple and direct approach to effectively treat patients with chronic sinusitis. For more information about Entellus Medical and FinESS Sinus Treatment, please contact us at 763/463-1595 or www.entellusmedical.com.