Second Sight Medical released new results from a small study of its Argus II retinal prosthesis, reporting statistically significant improvement in object recognition in patients with a blinding genetic disease.
In a trial of 8 enrolled participants, researchers found that patients using the Argus II system were as much as 4 times more likely to recognize objects compared with those in the control group.
"Despite the small sample size, statistically the results have achieved significance due to the magnitude of change in the performance of the use of the device within each subject," lead researcher Yvonne Luo of London’s Moorfields Eye Hospital NHS Foundation Trust said in prepared remarks. "Moreover, these subjects represent people with the most severe form of the disease."
Catch the story behind the “bionic eye” at this year’s MassDevice Big 100 West
The trial compared patients using the Argus II system in its intended mode against those with the device switched off and those with the device in a "scramble" mode. Patients with the active Argus II were able to accurately identify solid objects 32.8% of the time, compared with 12.5% with the device turned off and 26.2% with the device in scramble mode.
Researchers further evaluated visual identification of objects with "enhanced outlines," reporting 41.4% correct identification with the Argus II system active, 9.4% with the device off and 20.7% with the device scrambled, according to a press release.
The 1st-of-its-kind Argus II system is comprised of 2 main components: an eyeglass-mounted camera and an electrical stimulator implanted in the eye. The device converts images captured by the camera into a series of electrical pulses that are transmitted wirelessly to electrodes in the retina to simulate vision.
FDA regulators in February approved Argus II for treating blindness due to late stage retinitis pigmentosa, a condition that leaves patients with either bare light perception or none at all. There is currently no cure for the rare condition, which is diagnosed about 250 times each year. Earlier this year Swiss vision-treatment devices maker Second Sight Medical touted Medicare reimbursement coverage for the Argus II, now tallying coverage the U.S., Germany and Italy.
The Argus II system has gotten a lot of attention as a one-of-a-kind solution to an incurable disease. Argus II was the #1 device on Cleveland Clinic’s top medical innovations for 2014 and even made a featured cameo as part of the $1-million-dollar medtech man, a walking, breathing humanoid robot built from the latest and greatest in medical prosthetics.
Second Sight founder and CEO Dr. Robert Greenberg is slated as the featured speaker during this year’s MassDevice Big 100 West round-table event in California.
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