FYSX (pronounced as physics) is an
intraocular pressure (IOP) adjusting pump, developed by Balance Ophthalmics.
The device has received FDA’s DeNovo
classification, which denotes a “risk-based classification process” to provide
a marketing pathway to classify novel medical devices that “provide reasonable
assurance of safety and effectiveness for the intended use.”
FYSX is a first-of-its-kind device that
provides a nonpharmacological, nonsurgical treatment modality to reduce IOP.
The device is particularly useful for
patients with primary open-angle glaucoma (POAG) and normal-tension glaucoma
(NTG).
The device features a portable pump attached
to pressure-sensing goggles that are worn at night when IOP typically
increases. Separate tubes are attached to each eyepiece to create/monitor
negative pressure.
The programmable pressure-modulating pump
is compact and portable. It incorporates two diaphragm pumps to create negative
pressure in each eye. Each pump exerts up to -40 mmHg relative atmospheric
pressure. The goggles and the pump are connected mechanically and pneumatically
through a tubing system.
The device reduces IOP so long as it
working and the effect apparently tapers off once the pump shuts down.
The most frequently reported ocular adverse
events with the use of FSYX are:
- Eyelid
edema (11.8%)
- Dry eye
signs and symptoms (5.4%)
- Conjunctival
hyperemia (4.3%)
- Eye pain
(3.2%)
- Eyelid
erythema (2.2%)
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