InnFocus MicroShunt® Glaucoma Drainage System
The Company's lead product is a drainage implant device that helps effectively drain eye fluid and reduces intraocular pressure that can prevent the progression of glaucoma and vision loss. The InnFocus MicroShunt® Glaucoma Drainage System (formerly known as MIDI Arrow) was developed with the University of Miami's Bascom Palmer Eye Institute, one of the world's leading ophthalmology institutes.
The Company's goal is to provide a safe, effective, intuitively performed alternative for the surgical treatment of glaucoma. Primary Open Angle Glaucoma is the Company's first area of focus and is currently under investigation in FDA trials and other studies around the world.
The drainage implant consists of an extremely small micro-tube (about twice the size of an eyelash) that shunts aqueous fluid from the anterior chamber of the eye to a sub-conjunctival/sub-Tenon flap. The shunt was designed to be thin and soft to conform to the curvature of the eye. The device is made of SIBS, the most biostable thermoplastic elastomeric material currently in existence.
The InnFocus MicroShunt® is designed to maintain a low level of intraocular pressure (in the mid to low teens). Intraocular pressure below 15mmHg is presumed to be paramount to preventing the progression of vision loss in glaucoma patients. The implantation is designed to be performed on an out-patient basis.
The MicroShunt™ received CE Mark in January 2012. It currently is the final phase of clinical study under the auspices of the U.S. Food and Drug Administration (FDA) in 29 centers in the U.S. and Europe. It is the world's only randomized trial against trabculectomy, the gold standard for lowering IOP.
The product has been implanted alone or in combination with cataract surgery in clinical trials outside of the U.S. in patients ranging from early to late stage glaucoma.
Caution: The InnFocus Microshunt™ is an investigational device in the United States and is limited by United States law to investigational use.