Entellus Medical

Indications and Instructions for Use

XprESSTM Multi-Sinus Dilation System

Indications for Use: To access and treat the maxillary sinus 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 trans-nasal approach. The bony sinus outflow tracts are remodeled by balloon displacement of adjacent bone and paranasal sinus structures.

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

Download PathAssist Brochure

PathAssist Light SeekerTM

Indications for Use: The PathAssist 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 PathAssist Light Seeker Instructions for Use below for complete instructions.

Download Light Seeker Instructions for Use

Download Light Seeker Specification Sheet

Download PathAssist Brochure

PathAssist Sinus Guidewire

Indications for Use: To provide a means to access the frontal, sphenoid and maxillary sinuses for diagnostic and therapeutic procedures in adults aged 18 and over.

Please see instructions for use for a complete listing of contraindications, warnings, precautions, and adverse events. Refer to PathAssist Sinus Guidewire Instructions for Use (IFU) for complete instructions.

Download Sinus Guidewire Instructions for Use

Download PathAssist Brochure

FinESSTM 5mm Sinus Treatment

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 below for a complete listing of contraindications, warnings, precautions, and adverse events.

Download FinESS Sinus Treatment Instructions For Use

Download FinESS Sinus Treatment Brochure

FinESS Endoscope

Indications for Use: The FinESS endoscope is intended to provide a means to visualize the maxillary sinus cavity and deliver the FinESS balloon dilation catheter to treat the maxillary sinus ostium and ethmoid infundibulum in adults with a trans-antral approach. The endoscope is part of the FinESS Sinus Treatment and is inserted via a sterile access sheath through the canine fossa.

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

Download FinESS Endoscope Instructions For Use

Download FinESS Endoscope Sterilization Tray Instructions For Use