Paradigm Medical Industries, Inc. has begun selling the Glaid-PERG electrophysiology instrument for the early detection of glaucoma. Pricing and volumes were not disclosed.
"We've recorded sales in select U.S. cities of this revolutionary FDA-approved device, following its introduction at the American Society for Cataract Refractive Surgeons (ASCRS) in April," said Paradigm Medical's Chief Executive Officer Raymond Cannefax. "And we will have an aggressive launch for the remainder of the year.
"The PERG (pattern Electroretinogram) should be a standard of care since it provides the earliest detection of glaucoma with the intent to arrest the progression of the disease and prevent or minimize it without further damage to the retina," Cannefax added. "In addition to early detection, the PERG is very valuable in the management of glaucoma."
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Glaucoma, caused by deterioration of the optic nerve and related ganglion cells, is the second-leading cause of permanent vision loss. It affects one of five people over age 50. There are more than 64 million cases of glaucoma worldwide, including more than three million in the U.S. The cost to the U.S. government related to glaucoma is estimated to be more than $1.5 billion annually.
"The PERG has gone through extensive development at Bascom Palmer Eye Institute (Miami and Palm Beach, FL) and other major ophthalmic centers in North America. Paradigm Medical is now taking this diagnostic tool from the research segment to the commercial marketplace," Cannefax noted. "We believe the PERG should be a mandatory test given to every individual who has a family history of glaucoma or is otherwise disposed to being a glaucoma suspect. And we believe it should be given as part of eye examinations to everyone over age 45 on a regular basis."
Paradigm Medical has an exclusive agreement with LACE Elettronica srl (Rome, Italy) to distribute the latter's Glaid-PERG device. The PERG was approved by the U.S. Food and Drug Administration (FDA) in 2004 and is approved for Medicare coverage.