Steve Austin would be proud. Los Angeles-based Second Sight Medical Products may now sell its Argus II retinal prosthesis system in the European Economic Area. And according to The Australian, this news has caused some discomfort for those Australian companies that have been trying to become world leaders in commercializing the bionic eye.
"After years of research, we are very happy to be able to offer a viable long-term solution for people suffering from advanced retinal degenerative diseases such as retinitis pigmentosa (RP)," says Robert Greenberg, president and CEO of Second Sight. "The CE Mark approval, which comes after intense regulatory review of our trial and our device, represents a huge step forward for the field and for these patients who have, until now, had no proven treatment alternatives."
The Argus II will go on sale "in the coming months" in Europe, Second Sight business development VP Brian Mech told The Australian. Furthermore, Australia is one of a series of countries on Second Sight's radar for marketing and transplanting the eye, the company says. The device, which includes the implant, glasses, camera and battery, would cost $100,000 and surgery about $10,000 to $15,000, according to Mech.
This approval could be seen as a setback for Australian devicemakers aiming to become leaders in this area. Australian Prime Minister Kevin Rudd has said bionic eye technology "could be the most important medical advancement in our lifetime." To this end, Australian consortium Bionic Vision Australia (BVA) and its research partners were granted AU$42 million of AU$50 million in government funds for R&D. But U.S. and German researchers appear have an edge in developing and marketing bionic eye technology; BVA only aims to hold its first clinical trials in 2013.
Second Sight could soon be joined in Europe by Germany's Retina Implant, whose president, Walter Wrobel, said his company planned to obtain CE marking next year for sale of its device. Already his company had implanted 11 patients in its clinical trial, and six in its main clinical study, The Australian notes.
The Argus II device is not yet available in the U.S.
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