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The ACCLARENT AERA® Eustachian Tube Balloon Dilation System is intended to dilate the Eustachian tube for treatment of persistent Eustachian tube dysfunction in patients ages 18 and older. For patients ages 8-17 years, the ACCLARENT AERA® Eustachian Tube Balloon Dilation System, alone or in combination with adjunctive procedures, is intended to treat patients with objective signs of persistent obstructive Eustachian tube dysfunction from inflammatory pathology, resulting in chronic otitis media with effusion and are refractory to at least one surgical intervention for persistent obstructive Eustachian tube dysfunction.

The ACCLARENT AERA® Eustachian Tube Balloon Dilation System includes a Eustachian Tube Balloon Catheter and Guide Catheter designed specifically for use in accessing and dilating the Eustachian Tube. The system is used with the following additional devices: the Acclarent® SE Inflation Device (or Acclarent® Balloon Inflation Device). The Acclarent® SE Inflation Device or Acclarent® Balloon Inflation Device is used to inflate the balloon. All devices are provided sterile for single-patient use. The ACCLARENT AERA® Eustachian Tube Balloon Dilation System includes is a 6x16mm (inflated diameter x length) flexible Balloon Catheter with an integrated shaft and a nylon balloon at the distal tip. The non-compliant balloon is designed to dilate the cartilaginous portion of the Eustachian tube. The shaft consists of dual lumen tubing with an actuator component that is designed to assist in rotation and advancement of the balloon catheter. The balled catheter tip (aka, “blueberry tip") on the balloon catheter is designed to restrict advancement of the device into the bony portion of the Eustachian tube, known as the isthmus. There is an endoscopic marker placed at the proximal taper of the balloon to aid in positioning under direct endoscopic visualization. The AERA Guide Catheter is anatomically designed to facilitate AERA Balloon Catheter access to the Eustachian tube. The AERA Guide Catheter incorporates an atraumatic distal tip and distal angled tip profile that facilitates access to the Eustachian tube. The Guide Catheter supplied with the ACCLARENT AERA® Eustachian Tube Balloon Dilation System contains a lubricious inner liner to allow smooth passage for the balloon catheter and includes a hypotube for rigidity.

The TruDi® Navigation system is intended for use during surgical procedures in ENT and ENT skull base surgery to support navigation of instruments to targeted anatomy, where reference to a rigid anatomical structure can be identified relative to a CT or MR based model.

The TruDi® Navigation System V3 is intended to be used during surgical procedures in ENT and ENT skull base surgery to support navigation of instruments to the targeted anatomy, where reference to a rigid anatomical structure can be identified relative to a CT or MR based model. The TruDi® Navigation System V3 enables ENT physicians to access sphenoid, frontal, and maxillary sinuses, as well as the skull base, by using the systems magnetic tracking technology, which is the same technology used by the predicate device. The system incorporates a Navigation Console, Emitter Pad, Instrument Hub, Patient Tracker, Registration Probe, Workstation and peripherals. A magnetic field generated by the Emitter Pad induces a current in the magnetic sensor embedded in the tip of the navigated tool, which helps to accurately calculate the tool tip position. A CT or MR image is imported and registered to the patient coordinates and the navigated tool tip icon is displayed on top of the registered image, indicating the position of the tool tip in reference to the patient anatomy. A Patient Tracker is fixed to the patient forehead to compensate for the head movement during the surgical procedure.

TruDi® Shaver Blades are intended for use with the Bien-Air S120 Shaver Handpiece and the TruDi® Navigation System to aid in the incision and removal of soft and hard tissue or bone in ENT, Maxillofacial surgery, Head and Neck and ENT skull base surgery. Their use is indicated for any medical condition in which the use of navigated surgery may be appropriate, and where reference to a rigid anatomical structure can be identified relative to a CT or MR based model. TruDi® Shaver Blades may be used in, but is not limited to, the following procedures: - · Endoscopic sinus surgery (such as ethmoidectomy, polypectomy, septoplasty) - · Drainage of mucoceles or abscesses that have extended from the paranasal sinuses and up to the dura mater - · Orbital decompression - · Any other of a number of tumors involving the lateral nasal wall, paranasal sinuses and orbit - · Access to the sphenoid sinus

The subject device, TruDi® Shaver Blade, is a single-use and sterile electromagnetically (EM) navigated instrument, which is intended to be used with the Bien-Air S120 Shaver Handpiece (reference device, K083720) and the TruDi® Navigation System (K192397) to aid in the incision and removal of soft and hard tissue or bone in ENT, Maxillofacial surgery, Head and Neck and ENT skull base surgery. The device is tracked by the navigation system within the low energy magnetic field volume generated by the TruDi® Navigation System. The TruDi® Navigation System software displays the position of the shaver blade distal tip on preoperative scans (e.g. CT, MRI). The TruDi® Shaver Blade consists of several configurations ranging from straight to curved blades of different diameters.

TruDi™ Curette is intended for use with the TruDi™ Navigation System to manipulate, dissect and/or remove tissue, cartilage and bone during surgical procedures in ENT and ENT skull base surgery.

The subject device, TruDi™ Curette (K201174), is a single-use and sterile electromagnetically (EM) navigated instrument, which is intended for use with the TruDi™ Navigation System (K192397) to manipulate, dissect and/or remove tissue, cartilage and bone during surgical procedures in ENT and ENT skull base surgery. The TruDi™ Curette consists of one configuration (straight 0°). The TruDi™ shaft, and a curette cup, which is located at the distal tip and houses a magnetic sensor. The device is sold in sterile packaging. Each package includes one TruDi™ Curette in conjunction with a disposable bending tool. The bending tool is provided to allow the user to customize the shape of the distal shaft as needed. The TruDi™ Curette incorporates a sensor at the distal tip, which is tracked by the TruDi™ Navigation System. The location of the distal tip of the device is identified by the navigation system and displayed in real-time view over the patient's pre-operative CT/MRI scan to confirm access, and to locate anatomical structures during ENT and ENT skull base surgery.

The TruDi™ Probe is intended for use with the TruDi™ Navigation System to locate anatomical structures during surgical procedures in ENT and ENT skull base surgery.

The subject device, TruDi™ Probe, is a single-use and sterile electromagnetically (EM) navigated instrument, which is intended for use with the TruDi™ Navigation System (K192397) to locate anatomical structures during surgical procedures in ENT and ENT skull base surgery. The TruDi™ Probe consists of two configurations, straight (0°) and frontal (70°). The TruDi™ Probe comprises of a fixed proximal connector, cable, handle, stainless steel shaft, and a distal tip that houses a magnetic sensor. The device is sold in sterile packaging. Each package includes one TruDi™ Probe (either straight or frontal) in conjunction with a disposable bending tool. The bending tool is provided to allow the user to customize the shape of distal tip as needed. The TruDi™ Probe incorporates a sensor at the distal tip, which is tracked by the TruDi™ Navigation System. The location of the distal tip of the device is identified by the navigation system and displayed in real-time view over the patient's pre-operative CT scan to confirm access and locate anatomical structures during ENT surgery.

The RELIEVA ULTIRRA® Sinus Balloon Catheter is an instrument intended to dilate sinus ostia and spaces within the paranasal sinus cavities for diagnostic procedures. It is also intended to irrigate from within a target sinus for therapeutic procedures and to facilitate diagnostic procedures. For children aged 17 and under, the balloon catheter system is intended to dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic and therapeutic procedures. It is also intended to irrigate from within a target sinus for therapeutic procedures and to facilitate diagnostic procedures. The RELIEVA ULTIRRA® Sinus Balloon Catheter may be utilized in conjunction with TruDi™ NAV Wire and TruDi™ Navigation System to provide access to nasal and sinus spaces, and to confirm placement in the accessed anatomy. It is NOT intended to irrigate from within a target sinus for therapeutic procedures nor to facilitate diagnostic procedures with TruDi™ NAV Wire.

The RELIEVA ULTIRRA® Sinus Balloon Catheter is a flexible catheter that is intended to dilate sinus ostia. The shaft allows for inflation of the sinus balloon and permits the passage of an electromagnetic navigable sinus guidewire or sinus illumination system to facilitate access to the target sinus ostia. A hypotube is incorporated on the proximal end to provide rigidity during insertion through a sinus guide catheter.

The TruDi™ NAV Wire is intended for use as an electromagnetically navigable guidewire to provide access and confirmation of placement in the patient anatomy. The device is intended for use during ENT procedures where reference to a rigid anatomical structure can be identified relative to a CT-based model of the anatomy.

The subject device, TruDi™ NAV Wire, is a single-use electromagnetically (EM) navigated, flexible guidewire, which is compatible for use with the TruDi™ Navigation System to provide access and confirmation of placement in patient anatomy during intranasal and paranasal surgeries. The TruDi™ NAV Wire is intended to provide real-time tracking at the distal tip of the guidewire in the nasal anatomy and is intended to be used during ENT procedures where reference to a rigid anatomical structure can be identified relative to a CT-based model of the anatomy. The subject device, TruDi™ NAV Wire, may be used with compatible non-ferromagnetic instruments that have a lumen of greater than 1mm in diameter and a luer lock mechanism to fix the wire onto the instrument.

The RELIEVA TRACT™ Balloon Dilation System is an instrument intended to provide increased intranasal space to facilitate access for endonasal and transnasal procedures and/or temporarily address nasal obstruction by displacing the inferior turbinate and lower nasal septum. The RELIEVA TRACT™ Balloon Dilation System is intended for use in ages 17 years or older.

The RELIEVA TRACT™ Balloon Dilation System is a single-use, sterile device, which is intended to provide increased intranasal space to facilitate access for endonasal and transnasal procedures and/or temporarily address nasal obstruction by displacing the inferior turbinate and lower nasal septum. It is intended for use in ages 17 years or older. The RELIEVA TRACT™ Balloon Dilation System is composed of: - A RELIEVA TRACT™ Balloon Catheter, which consists of an integrated shaft system and a high-pressure balloon near the distal tip. The shaft is a coaxial catheter. The outer lumen is used for inflation of the balloon with sterile water or saline via the ACCLARENT® Balloon Inflation Device (K090660). The inner lumen permits the use of the RELIEVA TRACT™ Stylet to facilitate advancement of the balloon catheter to the target location, such as the nasal passage in the region of the inferior turbinate and nasal septum. The proximal end of the RELIEVA TRACT™ Balloon Catheter consists of a luer that is used for inflation of the balloon and a secondary luer that is used for stylet access. The balloon is inflated by injecting sterile water or saline through the inflation luer. - A RELIEVA TRACT™ Stylet, which is an optional accessory and intended to facilitate advancement of the Balloon Dilation Catheters. The proximal end has a luer connector that allows the stylet to lock into the stylet port of the balloon catheter. The distal end consists of an atraumatic tip.

TruDi™ NAV Suction Instruments are intended for use with the TruDi™ Navigation System during surgical procedures in ENT medicine and skull base surgery to provide navigation of the instruments to the targeted anatomy, and evacuation of gases, liquids, and fragments. TruDi™ NAV Suction Instruments are intended to be used by ENT surgeons or support staff.

TruDi™ NAV Suction Instruments (0°, 70°, 90°) are electromagnetically- navigated reusable devices intended to be used in conjunction with the TruDi™ Navigation System. When used with the TruDi™ Navigation System, the TruDi™ NAV Suction Instruments provide navigation of the devices to targeted anatomy and evacuate gases, liquids, and fragments. The TruDi™ Navigation System is the trade name for the ACCLARENT® ENT Navigation System cleared in K173628. TruDi™ NAV Suction Instrument Set consists a 0° suction instrument, 70° suction instrument, 90° suction instrument, and a single-use sterile cable called the TruDi™ NAV Cable. The TruDi™ NAV Cable may be used to connect the suction instruments to the TruDi™ Navigation System. The TruDi™ NAV Suction Instruments include an EM trackable single axis sensor, which is integrated at the distal tip of the device. The TruDi™ Navigation System acquires the position and orientation of the distal tip of the device and displays it in real-time view over the patient's pre-operative CT scan to confirm access of target anatomy. Following confirmation, the physician operates the surgical instrument at the target anatomical structure.

The ACCLARENT® ENT Navigation System is intended for use during intranasal and paranasal image-guided navigation procedures for patients who are eligible for sinus procedures.

The ACCLARENT® ENT Navigation System is intended to be used during intranasal and paranasal surgical procedures to help ENT physicians to track and display the real-time location of the tip of navigated instruments relative to pre-acquired reference images, such as CT. The ACCLARENT® ENT Navigation System enables ENT physicians to access sphenoid, frontal, and maxillary sinuses by using the system magnetic tracking technology, identical to the predicate device. The system incorporates a Navigation Console, Field Ring, Instrument Hub, Patient Tracker, Registration Probe, Field Ring and Holder, Workstation and accessories. A magnetic field generated by the Field Ring induces a current in the magnetic sensor embedded in the tip of the flexible navigated tool, which helps to accurately calculate the tool tip position. A CT image is imported and registered to the patient coordinates and a tool tip icon is displayed on top of the registered