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Use a single dilation device by transnasal approach to access and treat an individual anatomical location as follows: · Remodel by balloon displacement the adjacent bone and paranasal sinus structures in the Maxillary ostialethmoid infundibula in patients 2 years and older; · Remodel by balloon displacement the adjacent bone and paranasal sinus structures in the Frontal ostialrecesses in patients 12 years and older: may be used with LED Light fiber to locate, illuminate across nasal and sinus structures; · Remodel by balloon displacement the adjacent bone and paranasal sinus structures in the Sphenoid sinus ostia in patients 12 years and older; • Dilation of the cartilaginous portion of the Eustachian tube for treating persistent Eustachian tube dysfunction in patients 18 years and older.

The SINUSPRIME Dilation System is intended to remodel or recreate the sinus outflow tract and dilate the Eustachian tube by transnasal balloon dilation. Each packaged SINUSPRIME System includes a balloon device configured for a specific anatomy (frontal, sphenoid, maxillary, or Eustachian tube (ET) configuration) and an inflation device. The SINUSPRIME Dilation System combines features of an ostium seeker with the tissue expansion effect of balloon dilation. The SINUSPRIME Dilation System is provided sterile and for single use only. The familiar features of this device enable a physician to track the device into the sinuses and Eustachian tubes using endoscopic visualization. The SINUSPRIME LED Light Fiber consists of a flexible illumination fiber that allow physicians to locate, illuminate within, and trans-illuminate across nasal and sinus structures. The SINUSPRIME LED Light Fiber is optional and available packaged and pre-loaded only on the SINUSPRIME Frontal with LED model.

The TGS Guidewire is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of ENT surgery, such as the paranasal sinuses, mastoid anatomy, can be identified relative to a CT- or MR- based model of the anatomy. Example procedures include, but are not limited to: - · Transsphenoidal access procedures - Intranasal procedures · Sinus procedures, such as maxillary antrostomies, sphenoidotomies/sphenoid explorations, turbinate resections, and frontal sinusotomies - · ENT-related anterior skull base procedures The TGS Guidewire is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. It is intended for use with the Stryker ENT Navigation System and the XprESS LoProfile ENT Dilation System during balloon sinus dilation procedures. The Scopis ENT Software is an accessory to the Electromagnetic Navigation Unit and intended for controlling of the hardware of the navigation unit. The Scopis ENT Software with TGS (Target Guided Surgery) is an accessory to the Electromagnetic Navigation Unit and intended for controlling of the hardware of the navigation unit.

The TGS Guidewire is a single use, sterile, disposable instrument intended to be used with the Stryker ENT Navigation System and the XprESS LoProfile ENT Dilation System. The instrument is an electromagnetically navigated device which consists of a sensor in a protective sheath that can be inserted into the working lumen of the XprESS device, a bayonet connector to secure the device to the XprESS luer and a cable and plug to connect the device to the navigation system. The navigation system displays the position of the instrument in the preoperative scans. The Scopis ENT Software is an accessory to the Electromagnetic Navigation Unit and intended for controlling of the hardware of the navigation unit. The Scopis ENT Software with TGS (Target Guided Surgery) is an accessory to the Electromagnetic Navigation Unit and intended for controlling of the hardware of the navigation unit.

The Stryker ENT Navigation System, of which the TGS Universal Headrest with Mounting Arm is an accessory, is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of ENT surgery, such as paranasal sinuses, mastoid anatomy, can be identified relative to a CT or MR based model of the anatomy. Example procedures include, but are not limited to the following ENT procedures: - · Transsphenoidal access procedures: - Intranasal procedures: - · Sinus procedures, such as maxillary antrostomies; sphenoidotomies/sphenoid explorations, turbinate resections, and frontal sinusotomies: - · ENT related anterior skull base procedures.

The TGS Universal Headrest with Mounting Arm is a reusable device intended to be used with the Stryker ENT Navigation System. It consists of three main components: a headrest, mounting arm and chair adapters. The mounting arm provides fixation for the field generator of the navigation system allowing it to be positioned in proximity to the patient creating an optimal electromagnetic field. The headrest provides support for the patient's head while undergoing navigation guided procedures. The chair adapters are fixed to the headrest to allow the headrest to various ENT procedure chairs

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

The LATERA Absorbable Nasal Implant System is intended to support upper and lower lateral cartilage in the nose. The system consists of the LATERA Absorbable Nasal Implant) and Delivery Device (Delivery Device). An Implant Positioning Guide is provided to serve as an external visual planning aid prior to Implant placement. The Implant is composed of a PLLA-PDLA copolymer that is predominantly cylindrical in shape with an approximate diameter of 1mm and lengths of 20mm and 24mm. The distal end of the Implant is forked to facilitate anchoring during implantation and the proximal end is narrower for increased flexibility. The disposable Delivery Device is comprised of a non-patient contacting handle assembly and a medical grade stainless steel 16-gauge delivery cannula. The Delivery Device enables placement of the Implant in a minimally invasive manner. Each Implant length (20mm, 24mm) is compatible with the Delivery Device packaged with the Implant. The LATERA Absorbable Nasal Implant System is provided sterile and is intended for single-use only.