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Entellus Medical Receives FDA 510(k) Clearance for FinESS(TM) Endoscope


2/24/2011 7:14:06 AM

MINNEAPOLIS--(BUSINESS WIRE)-- Entellus Medical, a Minnesota-based medical technology company, announced today that the U.S. Food and Drug Administration cleared the company’s new FinESS Endoscope. The endoscope is used with the FinESS Sinus Treatment, which employs minimally-invasive balloon dilation to open narrowed sinus drainage paths and relieve symptoms in patients with recurrent or chronic sinusitis. The new Entellus endoscope enables treatment of sinusitis patients in the doctor’s office by delivering enhanced image quality and visualization of the sinus thereby potentially reducing procedure time.

The Entellus FinESS system treats the two most commonly inflamed sinuses, the maxillary and anterior ethmoid sinuses. Designed to be performed in the doctor’s office setting, FinESS is the only balloon dilation system on the market that predictably allows direct visualization of the maxillary sinus opening. This ensures treatment of the natural sinus drainage pathways.

According to Entellus Medical CEO Brian Farley, “Our new endoscope provides ENT physicians a clear visual perspective to quickly guide sinus balloon catheter placement and successfully treat patients in the doctor’s office. This practice-changing technology greatly enhances the treatment options for physicians and their patients who suffer from sinusitis.”

Clinical results published to date indicate that the FinESS Sinus Treatment is effective in keeping treated sinuses open, with clinically meaningful improvement in sinus symptoms demonstrated at each follow-up visit.1 On average, FinESS patients experience a 70% improvement in quality of life related to sinusitis symptoms.2 The data from this study also demonstrate that the procedure is safe and well tolerated, with 90% of patients able to return to normal activity within 48 hours of the procedure.3

Sinusitis is a common medical condition in which inflammation of the sinuses causes mucus blockage, sinus infection, and significant patient discomfort. The use of balloon sinus dilation to treat appropriate sinusitis patients is covered by Medicare and a number of private health insurance plans.

About Entellus Medical™: Founded in 2006, Entellus Medical delivers innovative, high quality minimally invasive therapeutic solutions to healthcare providers and their patients who suffer from sinusitis. Based in Maple Grove, Minn., Entellus Medical manufactures markets and distributes the FinESS™ Sinus Treatment which breaks the cycle of recurring sinusitis with immediate relief and lasting results and the XprESS™ Multi-Sinus Dilation Tool that enables ENT physicians to treat multiple sinuses with one tool that is familiar and easy to use. For more information about Entellus Medical, FinESS Sinus Treatment and the XprESS Multi-Sinus Dilation Tool visit www.entellusmedical.com or call 763/463-1595.

1 Stankiewicz, James MD, Truitt, Theodore MD, and Atkins, James MD. “One Year Results: Transantral balloon dilation of the ethmoid infundibulum” ENT Journal February 2010 Volume 89, Number 2.

2 Stankiewicz, James MD, Truitt, Theodore MD, and Atkins, James MD. “One Year Results: Transantral balloon dilation of the ethmoid infundibulum” ENT Journal February 2010 Volume 89, Number 2.

3 Stankiewicz, James, et al. “Transantral, endoscopically guided balloon dilation of the local ostiomeatal complex for chronic rhinosinusitis under local anesthesia” Am J Rhinol Allergy 2009; 23 (3): 321-7.

Contact:

For Entellus Medical Kathleen Crandall, 612-327-6336 kathleen@crandallcommunications.com


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