FDA Clears Dedicated Glaucoma Laser from Iridex

Iridex Corporation says it has received U.S. FDA 510(k) clearance for its Cyclo G6™ Laser System, the first laser system designed solely for use in treating glaucoma and its symptoms.

Background

Glaucoma is the leading cause of irreversible blindness in adults with estimates suggesting more than 4 million people in the U.S. and approximately 60 million worldwide are afflicted with the condition.

The Cyclo G6 laser system is specifically intended for the treatment of treat patients diagnosed with a range of glaucoma disease states. It features Iridex’s proprietary MicroPulse tissue-sparing technology and a family of single use probes that connect to an intuitive, user-friendly laser console.

The system will initially be sold with two disposable delivery probes, the MicroPulse P3™ probe and the G-Probe™, and Iridex says it plans a series of additional new probe introductions in the coming year that allow for a broader range of application in glaucoma treatment.

Physician comments

Glaucoma and cataract specialist Robert Noecker, MD of the Ophthalmic Consultants of Connecticut stated, “MicroPulse allows for a clinically effective and repeatable option that can slow the progression of the disease and delay both surgical intervention and ultimate blindness.”

Company comments

“The Cyclo G6 system extends the reach of IRIDEX’ proprietary MicroPulse technology to a broader group of ophthalmologists who are seeking better alternatives for treating glaucoma than drug regimens or invasive surgical procedures,” said William Moore, IRIDEX President & CEO. “That added reach, combined with the recurring use of specialty probes associated with the Cyclo G6, is expected to help drive growth in an important recurring revenue component of our business.”

Source: PR Newswire

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