Entellus Medical

Indications and Instructions for Use

XprESSTM ENT Dilation System

Indications for Use: To access and treat the maxillary ostia/ethmoid infundibula in patients 2 years and older, and frontal ostia/recesses and sphenoid sinus ostia in patients 12 years and older using a transnasal approach. The bony sinus outflow tracts are remodeled by balloon displacement of adjacent bone and paranasal sinus structures.

To dilate the cartilaginous portion of the Eustachian tube for treating persistent Eustachian tube dysfunction in patients 18 years and older using a transnasal approach.

Please see the Instructions for Use below for a complete listing of warnings, precautions and adverse events.

Download XprESS Instructions for Use

Download XprESS Brochure

PathAssistTM Light FiberTM and PathAssist LED Light Fiber

Indications for Use: To locate, illuminate within, and transilluminate across nasal and sinus structures.

Please see Instructions For Use for a complete listing of contraindications, warnings, precautions, and adverse events.

Download PathAssist Light Fiber Instructions for Use

Download PathAssist LED Light Fiber Instructions for Use

MiniFESSTM Light SeekerTM

Indications for Use: The MiniFESS Light Seeker is intended to locate, illuminate within, and transilluminate across nasal and sinus structures, including the frontal, ethmoid and maxillary sinuses, in patients aged 18 and over.

Please review the Instructions for Use for a complete listing of contraindications, warnings, precautions and adverse events. Refer to MiniFESS Light Seeker Instructions for Use below for complete instructions.

Download Light Seeker Instructions for Use

Entellus Medical Portable Red LED Light Source

Indication for Use: The Light Source is indicated for use in endoscopic procedures to locate, illuminate within, and transilluminate across nasal and sinus structures when used with the Entellus Medical MiniFESS TM Light SeekerTM.

Download Entellus Medical Portable Red LED Light Source Instructions for Use

MiniFESS Sterilization Tray

Indications for Use: The MiniFESS Sterilization Tray is used to organize and protect the MiniFESS instruments that are sterilized by a healthcare provider. The MiniFESS Sterilization Tray is intended to allow sterilization of the enclosed medical devices during a pre-vacuum steam sterilization cycle. The Tray is intended to be used in conjunction with a legally marketed wrap. The Tray is not intended on its own to maintain sterility.

Download MiniFESS Sterilization Tray Instructions for Use

FocESSTM Sinuscope

Indications for Use:The FocESS Sinuscope if intended to provide the physician with a means for endoscopic diagnostic and therapeutic sinus surgical procedures. The Sinuscope is indicated for use in, but not limited to such procedures as examination of sinus passages and cavities, removal of abnormal growths such as polyps and facio-plastic surgery.

Download FocESS Sinuscope Instructions for Use

FocESS Sinuscope Sterilization Tray

Indications for Use:The FocESS Sinuscope Sterilization Tray is used to organize and protect the FocESS Sinuscopes that are sterilized by a healthcare provider. The FocESS Sinuscope Sterilization Tray is intended to allow sterilization of the enclosed medical devices during these sterilization cycles: pre-vacuum steam, STERRAD® 100S Standard, STERRAD® 100NX Standard, ethylene oxide, STERRAD® NX Standard, STERRAD® 100NX Express. The Tray is intended to be used in conjunction with a legally marketed wrap. The Tray is not intended on its own to maintain sterility.

Download FocESS Sinuscope Sterilization Tray Instructions for Use

FocESS HD Wireless Camera

Indications for Use:The FocESS HD Wireless Camera is indicated for use in endoscopic procedures to allow visualization of the nasal and sinus cavities when used with an appropriately indicated endoscope. Intended Use: The FocESS HD Wireless Camera is intended for use in a physician’s office during endoscopic sinus examinations and procedures. The Wireless Camera is not intended for use in the sterile field.

Download FocESS Wireless Camera Instructions for Use

Entellus MedicalTM Shaver System

Indications for Use:The Entellus Medical Shaver System has been designed for shaping bone and for the resection of soft and hard tissues as part of surgical procedures in the areas of otorhinolaryngology. Refer to Instructions for Use for a complete listing of warnings, precautions, and adverse events.

Download Shaver System Instructions for Use

Download Single Use Shaver Blade Instructions for Use

Download Reusable Shaver Blade Instructions for Use

CycloneTM Sinonasal Suction/Irrigation System

Indications for Use:To provide a means to irrigate and suction within sinonasal spaces. Please see the Instructions for Use for a complete listing of warnings, precautions and adverse events.

 

Download Cyclone Instructions for Use

Entellus Medical Reinforced Anesthesia Needle

Indications for Use: For use in injecting local anesthetics into a patient to provide regional anesthesia. Please see Instructions for Use (IFU) for a complete listing of warnings, precautions, and adverse events.

 

Download Reinforced Anesthesia Needle Instructions for Use

LATERATM Absorbable Nasal Implant

Indications for Use: The LATERA Absorbable Nasal Implant is indicated for supporting upper and lower lateral nasal cartilage.

Please see Instructions for Use for a complete listing of warnings, precautions and adverse events.

 

XeroGel™ Nasal Epistaxis/Pack

Indications for Use: XeroGel is indicated for use in patients undergoing nasal/sinus surgery as a space-occupying packing to:

  • Separate tissue or structures compromised by surgical trauma;
  • Separate and prevent adhesions between mucosal surfaces; including during mesothelial cell regeneration in the nasal cavity;
  • Help control minimal bleeding following surgery or trauma;
  • Help control minimal bleeding following surgery or trauma by tamponade effect, blood absorption and platelet aggregation;
  • Act as an adjunct to aid in the natural healing process.

XeroGel is indicated for use as a nasal packing to treat epistaxis.

XeroGel Contraindications: This product is contraindicated for use in patients with a known hypersensitivity/ allergy to shellfish.

Download XeroGel Instructions for Use

XeroGel