Seeing the Solution

The announcement that Second Sight Medical Products’ Argus II retinal implant has been approved for sale in Europe [see article, p5] is exceptionally good news for the neurotech industry and for visually impaired people all over the world. The approval represents the first ever for a device restoring vision to blind people.

The Argus II will only be available in four locations in Europe this year: the Centre Hospitalier National d’Ophthalmologie des Quinze-Vingts in Paris, France, the Hôpitaux Universitaires de Genève in Geneva, Switzerland, the Manchester Royal Eye Hospital in Manchester, England, and Moorfields Eye Hospital in London, England. But Second Sight said it is actively adding sites to make the therapy more readily available across Europe in the coming months and years. The company is also focused on obtaining insurance coverage for the device and surgical procedure.

The only downside to the Second Sight announcement is the fact the even though the device was developed in the U.S. by an American company, it will not be available in this country until the FDA approves it for sale. Like many other neurotechnology device companies, Second Sight made the decision to seek approval and begin marketing in Europe before doing so in the U.S., since the path to European approval is much more streamlined. This situation is not only a detriment to blind people in the U.S.—who are just as eager as European citizens to have any option for vision restoration—it is also an impediment to the U.S. economy, which needs new jobs drastically.

Because of the regulatory and reimbursement hurdles in this country, research, clinical, and marketing jobs that might have been created here are instead being shipped overseas. But unlike the situation in other industries where manufacturing jobs are being exported to third-world countries with low wages and marginal safety records, these medical technology jobs are being shipped to high-wage countries with product safety records that exceed our own in many cases.

Why is it that new medical devices are more readily approved in Europe than in the U.S.? It certainly isn’t because of a lack of concern for safety in Europe. Rather, it is because of the exceedingly conservative nature of regulators in this country. There is very little disincentive for a regulator to deny approval for a new device, while there is much incentive on the part of the FDA and Medicare to block new products coming to market, especially since there’s not enough money to fund our current medical system.

Until this situation addressed, Americans with visual impairments and other neurological disorders will have to watch as innovations that could help them are offered first to people in Europe.

James Cavuoto
Editor and Publisher



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