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The ProSomnus® EVO Sleep and Snore Device is intended to reduce night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults. Optionally, if the DentiTrac micro-recorder is completely embedded in the ProSomnus® EVO Sleep and Snore Device. the micro-recorder is intended to measure patient compliance therapy in combination with the DentiTrac System.

The ProSomnus® EVO Sleep and Snore Device is an oral device, which improves the flow of air through the patient's pharyngeal space during sleep by repositioning the mandible. The ProSomnus® EVO Sleep and Snore Device and the ProSomnus® EVO Sleep and Snore Device with Patient Monitoring consists of maxillary and mandibular devices that when interfaced together reduce snoring and mild to moderate obstructive sleep apnea by holding the mandible forward during sleep, providing increased pharyngeal space. These separate upper and lower device arches are CAD/CAM designed with twin-mated posts and are digitally milled to be patient-specific according to physician prescription. Customizable ergonomic features are available to improve patient comfort. Prescribed advancements can be achieved by simply removing the current upper or lower device arch and inserting the next upper or lower device arch in the mandibular advancement series. The device does not have any adjustment mechanisms to modify or maintain the mandibular position such as pistons, screws, straps, or repositioning elastics. The device is supplied nonsterile. A micro-recorder is completely embedded in the ProSomnus® EVO Sleep and Snore Device with Patient Monitoring. The micro-recorder is a compliance sensor, which logs the time the device is worn.

The TD Clip is intended to be used with MATRx or MATRx plus Titration Trays to form a mandibular repositioning device intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in patients 18 years and older. The device is intended to be fitted with assistance from a healthcare professional and used during sleep for a total of less than 30 nights.

The TD Clip is a temporary oral appliance. The patient uses the temporary oral appliance to alleviate mild to moderate obstructive sleep apnea and/or snoring while waiting for a custom oral appliance to be manufactured. The dentist fabricates temporary titration trays consisting of upper and lower dental trays. The trays are custom fit to the patient using polyvinyl siloxane impression material. The healthcare provider may use the clip assembly to fasten the titration trays at the target therapeutic position to form the TD Clip temporary oral appliance. Patients may use the temporary oral appliance as treatment while waiting for their custom oral appliance. Adjustment of the position requires the setting of a new TD Clip by the healthcare professional.

The Boston Scientific Tracking diagnostic catheters are indicated for cardiac electrophysiological mapping and delivering pacing stimuli. In addition, the Tracking and Reference Catheters are used with the Real-time Positions Management (RPM™) System to provide catheter location information.

Signal Acquisition Module (SAM): One of three main components of the RPM™ System that includes the Arrhythmia Mapping Computer (AMC) and the Position Acquisition Module (PAM). The SAM is an amplifier that filters cardiac signal data and transfers it to the AMC for processing and display. The SAM collects the following input signals, applies gain and filter settings as programmed through the Mapping System software and transfers them to the computer over the fiber optic data link for further processing and display. - 1. one or more standard EP catheter electrodes (up to 48 catheter inputs) - 2. two pacing inputs from an external pacing stimulator, which the Mapping System software can route to any catheter bipole or unipole - 3. a synch output channel that can be used with pacing stimulators to synchronize pacing inputs - 4. a 12-lead EKG - 5. two pressure transducer inputs - 6. One 64 electrode Constellation™ Catheter or up to 64 individual catheter inputs through bedside Expansion Pods

The Astronomer Plus™ System is a computerized system to assist in the diagnosis of complex cardiac arrhythmias. The Astronomer Plus™ System can be used to: - Display the relative location of catheters during cardiac mapping procedures (used exclusively with the Constellation® Catheter); - Route externally generated pacing stimuli and transmit cardiac electrogram (EGM) signals to electrophysiology recorders; and - Document electrophysiological procedures which make use of the Constellation® Catheter.

This device is a data management system intended for use within a cardiac electrophysiology lab for the creation, maintenance, and review of patient files generated during a typical electrophysiology study to assist in the diagnosis of complex cardiac arrhythmias. The device consists of a workstation running proprietary software, and catheter interface. The Astronomer Plus™ system is comprised of a catheter input box (the Switching & Locating Device) and a Computer, running a proprietary GUI (Astronomer Plus™). The system provides data to the physician obtained from the Constellation Catheter and a Roving (or auxiliary) Catheter (typically a quad catheter). The System has two window displays that simultaneously show: Constellation catheter orientation, roving catheter proximity indication, and user-defined markers. Additionally, the SLD routes signals received from the Constellation and Roving Catheters 1-to-1 to stand-alone EP recorders for acquisition, storage, and display purposes.