By: Malvina Eydelman, M.D.
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.
And, when the development and evaluation of a technology or device is more efficient, beneficial medical devices may be able to reach the patients who need them sooner, even though they may be more complex or challenging to study because they are breakthrough products.
For Second Sight, early interaction meant that specialists across disciplines such as ophthalmology and neurology, representing the sponsor and FDA, could pose questions and solve problems. Oftentimes, early interaction can be especially helpful in solving any potential stumbling blocks – for instance, how best to go about measuring the benefits or risks of devices.
In normal vision, the optic nerve connects the eye to the brain. The optic nerve carries the electrical impulses (signals) formed by the retina (specialized nerve tissue at the back of the eye) to the visual cortex. The brain processes these impulses into the images that we perceive when we “see.”
There was no standard way to evaluate the benefits or risks of a device like the Second Sight Orion, which mimics the perception of light through a miniature video camera worn by a patient that transmits signals to an implant in their visual cortex.
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, 2018.
The Orion isn’t the only device to take advantage of the Breakthrough program. Since the Cures Act was passed, CDRH has received 94 requests for breakthrough status for devices treating a variety of conditions and granted 54, with patients as the ultimate beneficiaries.
In FDA’s Breakthrough Device Program, the interaction among specialists across disciplines representing the sponsor and FDA, could lead to devices that have the potential to change patients’ lives, without compromising safety or effectiveness.
In short, it shows FDA at its best, committed to patient access and willing to balance benefits and risks in a scientifically robust manner led by compassion and respect for the perspective of patients.
Malvina Eydelman, M.D., is the Director of the Division of Ophthalmic, and Ear, Nose, and Throat Devices, Office of Device Evaluation, at FDA’s Center for Devices and Radiological Health