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The NEUROMARK System is indicated for use in otorhinolaryngology (ENT) surgery for creation of radiofrequency (RF) lesions to disrupt posterior nasal nerves in patients with chronic rhinitis.

The NEUROMARK System is intended for the application of Radiofrequency (RF) energy to create lesions in mucosal tissue in otolaryngological [also known as Ear, Nose and Throat (ENT)] procedures in patients with chronic rhinitis. The NEUROMARK System is composed of the NEUROMARK Device and the NEUROMARK Radiofrequency (RF) Console. The NEUROMARK Device is a hand-held, single-use, bipolar radiofrequency device which comprises a handle, shaft, and treatment tip. The treatment tip, which is referred to as the End Effector, consists of an array of bipolar electrodes that deliver RF energy while monitoring feedback on tissue bioimpedance changes allowing for controlled RF energy delivery. The shaft of the device is pre-shaped to aid access and delivery to the nasal cavity but is malleable to allow the user to bend or shape it to accommodate variations in anatomy to access the desired treatment area. The NEUROMARK Device is operated via handle, slider and activation button. Once in the desired position within the nasal cavity, the operator moves the slider backwards which retracts the outer sheath, deploying the End Effector. Using the activation button, the user initiates a bio-impedance check to assess and confirm contact between the End Effector and the treatment area. Once the System confirms contact has been achieved, a subsequent press of the activation button initiates the RF energy delivery cycle. The NEUROMARK Device is intended for single use and provided sterile (EO). The NEUROMARK Device is designed for use with the NEUROMARK Radiofrequency (RF) Console only and is connected via a flexible interface cable. The NEUROMARK Console delivers, monitors and controls RF energy to the Device. The Console includes a Graphical User Interface (GUI) which provides operational instructions for the procedure, directs the user to select nasal cavities for treatment, indicates when the device is in contact with tissue and ready to start treatment, provides status of therapy and indicates when the procedure is complete. The NEUROMARK Console works in conjunction with software.

The NEUROMARK® System is indicated for use in otorhinolaryngology (ENT) surgery for creation of radiofrequency (RF) lesions to disrupt posterior nasal nerves in patients with chronic rhinitis.

The NEUROMARK® System is intended for the application of Radiofrequency (RF) energy to create lesions in mucosal tissue in otolaryngological [also known as Ear, Nose and Throat (ENT)] procedures in patients with chronic rhinitis. The NEUROMARK® System is composed of the NEUROMARK® Device and the NEUROMARK® Radiofrequency (RF) Console. The NEUROMARK® Device is a hand-held, single-use, bipolar radiofrequency device which comprises a handle, shaft, and treatment tip. The treatment tip, which is referred to as the End Effector, consists of an array of bipolar electrodes that deliver RF energy while monitoring feedback on tissue bio-impedance changes allowing for controlled RF energy delivery. The shaft of the device is pre-shaped to aid access and delivery to the nasal cavity but is malleable to allow the user to bend or shape it to accommodate variations in anatomy to access the desired treatment area. The NEUROMARK® Device is operated via handle, slider and activation button. Once in the desired position within the nasal cavity, the operator moves the slider backwards which retracts the outer sheath, deploying the End Effector. Using the activation button, the user initiates a bio-impedance check to assess and confirm contact between the End Effector and the treatment area. Once the System confirms contact has been achieved, a subsequent press of the activation button initiates the RF energy delivery cycle. The NEUROMARK® Device is intended for single use and provided sterile (EO). The NEUROMARK® Device is designed for use with the NEUROMARK® Radiofrequency (RF) Console; it includes features to allow compatibility and authentication once connected, via a flexible interface cable, to the Console. The NEUROMARK® Console delivers, monitors and controls RF energy to the Device. The Console is mounted on an ergonomic mobile stand for ease of use. The Console includes a Graphical User Interface (GUI) which provides operational instructions for the procedure, directs the user to select nasal cavities for treatment, indicates when the device is in contact with tissue and ready to start treatment, provides status of therapy and indicates when the procedure is complete. The NEUROMARK® Console works in conjunction with software.

The NEUROMARK™ System is indicated for use in otorhinolaryngology (ENT) surgery for creation of radiofrequency (RF) lesions to disrupt posterior nasal nerves in patients with chronic rhinitis.

The NEUROMARK™ System is intended for the application of Radiofrequency energy to create lesions in mucosal tissue in otolaryngological [also known as Ear, Nose and Throat (ENT)] procedures in patients with chronic rhinitis. The NEUROMARK™ Device is a handheld bipolar radiofrequency device which is designed for use in otolaryngological [also known as Ear, Nose and Throat (ENT)] procedures along with the NEUROMARK™ Generator. The NEUROMARK™ System comprises of two key elements which are described in this section: - 1. The NEUROMARK™ Device and - 2. The NEUROMARK™ Generator The NEUROMARK™ Device is a hand-held single-use bi-polar radiofrequency device which comprises a handle, shaft, and treatment tip. The treatment tip, which is referred to as the End Effector, consists of an array of bipolar micro electrodes. These electrodes deliver bipolar RF energy while monitoring feedback on the tissue bio-impedance changes allowing for controlled RF energy level delivery. The shaft of the device is pre-shaped for optimal access and delivery to the nasal cavity but is malleable to allow the user to bend or shape the shaft to accommodate variations in anatomy to access the desired treatment area(s). The NEUROMARK™ Device is operated via handle, slider and activation switch. Once in the desired position within the nasal cavity, the operator moves the slider backwards which retracts the outer sheath, deploying the end effector array. Using the switch, the user initiates a bio-impedance check, to assesses and confirm contact between the end effector and the treatment area. Once the system contact has been achieved, a subsequent press of the button initiates the RF delivery cycle. The NEUROMARK™ Device is designed for use with the NEUROMARK™ Radiofrequency Generator; it includes features to allow compatibility and authentication once connected, via a flexible cable, to the NEUROMARK™ Radiofrequency Generator. The NEUROMARK™ Radiofrequency Generator delivers, monitors and controls RF energy to the device. The generator meets the following requirements: RF operating frequency of 460 – 480 kHz (± 5 kHz); bipolar low power energy delivery and feedback control with low overshoot capabilities. The NEUROMARK™ Device is intended for single use and provided sterile (EtO). The NEUROMARK™ Radiofrequency Generator is mounted on an ergonomic mobile stand for ease of use. The Graphical User Interface (GUI) provides operational instructions for the procedure; directs user to select nasal cavities for treatment, indicates when the device is apposed and primed to start treatment, provides status of therapy and indicates when the procedure is complete. The NEUROMARK™ Radiofrequency Generator works in conjunction with software. The subject device and predicate device have similar technological characteristics. The primary differences relate to the geometry of the electrode array and the method of controlling power delivery (bioimpedance control for the subject device versus temperature control for the predicate device).