Brain implant for some blind people shows benefits of FDA’s Breakthrough Device Program

From massdevice.com

By Malvina Eydelman, M.D., Director of the Division of Ophthalmic, and Ear, Nose, and Throat Devices, Office of Device Evaluation

FDA’s Breakthrough Devices Program is beginning to show important results for patients since it was established in late 2016 under the 21st Century Cures Act to help patients gain timely access to breakthrough technologies.

Consider Second Sight Medical Products Inc.’s Orion Cortical Visual Prosthesis System, which recently qualified for the FDA’s voluntary Breakthrough program.

Eligible technologies must provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases. In addition, there must be no approved or cleared treatment, or the device must offer significant advantages over existing approved or cleared alternatives.

The Orion is a brain implant for patients with blindness caused by damage to the optic nerve. With the designation, Second Sight qualified for interactive and timely communication with FDA, even before the Sylmar, Calif., company embarked on a clinical trial to study the device in patients. These early interactions resulted in the development of a flexible study design, review team support and senior management engagement, all of which may allow a sponsor to evaluate complex, innovative technologies more efficiently.
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Thanks to the breakthrough program, which builds on the FDA’s Expedited Access Pathway program, FDA was able to work closely with the company on a novel way to measure benefit and risk, clearing the way for the company to proceed with a small clinical trial, a necessary step before the company could seek approval for their device.

The Second Sight trial, approved by FDA’s Center for Devices and Radiological Health (CDRH), involves five patients at two sites, Baylor College of Medicine and the University of California in Los Angeles. The first patient received the implant on Jan. 30.