Tuesday, February 03, 2015
IRIDEX Corporation today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to market its first laser system designed solely for use in treating glaucoma and its symptoms. Specifically, the Company was granted 510(k) clearance for the IRIDEX Cyclo G6 Laser System (with delivery devices). The Cyclo G6 laser system is dedicated specifically to treat patients diagnosed with a range of glaucoma disease states and features the Company's proprietary MicroPulse tissue-sparing technology and a family of single use probes that connect to an intuitive, user-friendly laser console.
Glaucoma is the leading cause of irreversible blindness in adults. It is estimated that more than 4 million people in the U.S. and approximately 60 million worldwide are afflicted with glaucoma today and that number is increasing with the worldwide epidemic of obesity and diabetes. Of the millions that have the disease, it is estimated by the Glaucoma Research Foundation that less than half know they have it and are undergoing treatment. It is estimated that in terms of Social Security benefits, lost income tax revenues, and health care expenditures, the cost to the U.S. government is estimated to be more than $2 billion annually.
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."
The Cyclo G6 Laser System will initially be sold with two disposable delivery probes, the MicroPulse P3™ probe and the G-Probe™, and the Company plans a series of additional new probe introductions in the coming year that allow for a broader range of application in glaucoma treatment.
"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."
About IRIDEX
IRIDEX Corporation was founded in 1989 and is a worldwide leader in developing, manufacturing, and marketing innovative and versatile laser-based medical systems, delivery devices and consumable instrumentation for the ophthalmology market. We maintain a deep commitment to the success of our customers, with comprehensive technical, clinical, and service support programs. IRIDEX is dedicated to a standard of excellence, offering superior technology for superior results. IRIDEX products are sold in the United States through a direct sales force and internationally through a combination of a direct sales force and a network of approximately 70 independent distributors into over 100 countries.
Source : http://www.prnewswire.com/
