Search Results

The FSYXTM Ocular Pressure Adjusting Pump is indicated for the reduction of Intraocular Pressure (IOP) during sleep in adult patients with open-angle glaucoma and IOP ≤ 21 mmHg who are currently using or have undergone another IOP-lowering treatment.

The FSYX™ Ocular Pressure Adjusting Pump System is comprised of two distinct elements, the programmable pump and the goggles with tubing. The FSYX™ Ocular Pressure Adjusting Pump System is designed to allow the application and monitoring of bilateral negative pressure (NP) in the microenvironment in front of a patient's eves. The FSYX™ Ocular Pressure Adjusting Pump System goggles are designed to fit and seal around the eyes of patients, creating an air-tight chamber in which NP can be created and maintained. A headstrap is included with the goggles to facilitate reliable positioning on the patient's face during sleep. The goggles can be connected and disconnected from the FSYXM Ocular Pressure Adjusting Pump to allow for daily cleaning. FSYX™ Ocular Pressure Adjusting Pump System goggles should be replaced every 30 days. The FSYX™ Ocular Pressure Adjusting Pump houses 2 miniature diaphragm pumps that produce programmable NP pressure levels independently for each eye. The pumps are connected to a manifold that pneumatically interfaces the connector integral to the tubing system of the goggles. The manifold also mechanically and pneumatically connects a plurality of pressure sensors and relief valves. To create NP for each goggle lens, a pump extracts air from the cavity created by the goggle and the patient's face. The pump is pneumatically connected to the goggle through a negative pressure line comprised of a tube, a portion of the connector, and a portion of the manifold. The air extracted from the goggle is evacuated from the FSYX™ Ocular Pressure Adjusting Pump through a pneumatic path integral to the manifold. For each individual gogle. there is a separate pump and NP line, which allows independent NP application treatments for each eye. The NP inside each goggle is monitored by a pressure sensor that is pneumatically connected to the respective goggle through a sense line. The NP and sense lines for each goggle are pneumatically connected proximal to the goggle cavity; this ensures that creation and monitoring of the NP level in each goggle can occur independently. The signal from each sensor is used in a separate Proportional-Integral-Derivative (PID) control loop for each pump so that the applied NP matches the value entered by the treating physician. If leaks exist at the interface between the seal and the patient's skin. NP is reduced and the PID controller increases rotational speed of the pump to counterbalance the leak and reestablish the prescribed NP level. An additional differential pressure sensor is connected to each of the two independent sense lines to ensure that the differential signal matches the arithmetic difference between the NP levels set for the treatment of each eye and the actual NP levels sensed in each eye. An alarm is generated if the measured difference substantially departs from the arithmetic one. For each independent NP line, a relief valve is also provided to mechanically limit the maximum allowable applied NP to a level < 40 mmHg. The device is meant to be used at home. worn overnight while the patient sleeps. The Physicians App is an integral component to the FSYX™ Ocular Pressure Adjusting Pump System that allows the physician to program the FSYX™ Ocular Pressure Adjusting Pump with specific patient treatment parameters and to review patient wear information. Instructions on how to use the Physicians App preloaded onto a preconfigured laptop is available. Once programmed the FSYX™ Ocular Pressure Adjusting Pump can be activated by the patient at home via the touch-screen interface. Treatment programming is only possible via the Physicians App. The FSYX™ Ocular Pressure Adjusting Pump touch-screen interface only allows for patients to 1) start the treatment; 2) view treatment settings; and/or 3) pause and resume the treatment or completely stop the treatment after pausing.