FinESS

FinESS Sinus Treatment FamilyTake The Direct Approach

FinESS is a minimally-invasive office-based procedure that utilizes a small balloon catheter to dilate the ethmoid infundibulum and maxillary ostium, providing immediate relief to sinusitis sufferers. FinESS offers a number of benefits:

  • Direct visualization of the maxillary sinus opening ensures treatment of natural sinus pathways
  • Effective, safe, and well tolerated by patients
  • Easily integrated into your office

New Option for Recurrent and Chronic Sinusitis Patients

In the past, functional endoscopic sinus surgery was the only effective alternative to medical therapy for patients who suffered from recurring or persisting sinus infections. Now, FinESS Sinus Treatment offers a minimally invasive option for treating patients in an office setting.
Specific patient types that may benefit from the FinESS Sinus Treatment are those who:

  • suffer from recurrent sinusitis
  • present with chronic sinusitis with disease in the maxillary or maxillary and anterior ethmoid sinuses
  • cannot have traditional sinus surgery
  • do not want traditional sinus surgery

Practice Changing Treatment Offers Unique In-Office Advantages

Easy to integrate

  • Direct trans-antral access and visualization using a specialized endoscope ensures treatment in the natural ostium
  • Direct treatment eliminates the need to navigate challenging nasal passages while still preserving natural anatomy
  • Procedural steps of prep, access and treat can easily be integrated into your office

Treat patients comfortably

  • Proven local anesthesia protocol for patient comfort in the office
  • No need for nasal packing and post-op debridements
  • Widens drainage pathways for long-lasting relief

Increase practice opportunities

  • Consistent staffing and fewer delays can lead to quicker procedure turnaround time and increased efficiency
  • No need for nasal packing and post-op debridements
  • FinESS is a highly marketable procedure that will position your practice as a leader in the ENT community


Indications for Use:  To access and treat the maxillary sinus ostium and the ethmoid infundibulum in adults with a trans-antral approach.  The bony sinus outflow tract is remodeled by balloon displacement of adjacent bone and paranasal sinus structures.  Please see Instructions for Use for a complete listing of contraindications, warnings, precautions, and adverse events on the FinESS "Product Info" tab. 

 

©2012 Entellus Medical, Inc.
FinESS is a trademark of Entellus Medical, Inc.
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

Clinical data on FinESS Sinus Treatment

FinESS is Effective, Safe and Well Tolerated

  • FinESS improves quality of life related to sinusitis symptoms an average of 70% for at least 12 months1
  • No device-related serious adverse events or unanticipated adverse device effects were reported in BREATHE I2
  • This treatment is well tolerated, with 90% of patients able to return to normal activity within 48 hours of the procedure2
  • 90% patient satisfaction reported with this procedure3
  • Statistically significant (p<0.0001) and clinically meaningful (∆ ≥ 0.8) improvement in sinus symptoms at each follow-up visit

Case Studies from Balloon REmodeling Antrostomy THErapy
BREATHE I is a prospective, non-randomized, post-market, multi-center study designed to enroll a maximum of 100 subjects.  The objectives of the study are to evaluate the safety and effectiveness of the Entellus system in treating subjects with chronic rhinosinusitis (CRS) in the maxillary and anterior ethmoid sinuses.  This study will also assess the feasibility of performing the Entellus procedure using local anesthesia only.

Download Case Study #1
Download Case Study #2
More case studies available from your Entellus Medical Representative. Contact us today.

References
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, et al. “Transantral, endoscopically guided balloon dilatation of the ostiomeatal complex for chronic rhinosinusitis under local anesthesia” Am J Rhinol Allergy; 23 1-00 (2009).
3 Cutler, Jeffrey, MD. “Clinic vs OR - A Comparative Analysis of Ostial Dilation for CRS” In 56th Annual Meeting of the American Rhinologic Society; 2010 Sept 25; Boston, MA.
Catalog # Description
BC-700 5mm FinESS Sinus Treatment
ES-300b FinESS Endoscope

For more information or to place an order, contact:
EMAIL: customerservice@entellusmedical.com
PH: 866/620-7615
FAX: 866/620-7616
Download Instructions For Use, Gen 3 kit
Download Instructions For Use, FinESS Endoscope
Download FinESS Sinus Treatment Brochure

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