FDA Encourages Development of Devices for Patients with Disabilities

By: William Maisel, M.D., M.P.H.

William Maisel, M.D., M.P.H.For people with disabilities, medical devices can offer a vital and potentially life-changing option. Take, for example, a patient who has had his arms amputated. Medications can treat phantom pain, but they can’t help that patient pick up a glass of water. But devices can—and do.

In recent months, FDA has reviewed a number of noteworthy products for people with disabilities. And it has approved, cleared or allowed manufacturers to market several new devices.

Products that have met FDA’s premarket requirements include:

  • The DEKA Arm System, the first prosthetic arm that can perform multiple, simultaneous, powered movements controlled by electrical signals from electromyogram (EMG) electrodes;
  • The Nucleus Hybrid L24 Cochlear Implant System, which can help people aged 18 and over (who don’t benefit from conventional hearing aids) with a specific kind of hearing loss; and
  • The Argus II Retinal Prosthesis System, the first implanted device to treat adult patients with vision loss from advanced retinitis pigmentosa (RP).

FDA is committed to encouraging such innovation that benefits patients. We foster an approach that enables our staff to interact with device manufacturers and clarify our agency’s expectations for product evaluation. This communication can help new devices get to market in a timely fashion. We also listen to patients’ feedback, which helps us determine which devices may be particularly useful.

When it comes to regulatory decisions, we carry out tailored reviews that protect public health while advancing innovation. Each of the products recently approved or cleared by the agency has benefits that outweigh its risks. For example, in June we allowed marketing of ReWalk, a first-of-its-kind, motorized device. Risks associated with the exoskeleton-like device include pressure sores and injuries from falls. But the big benefit is that it can help patients with complete or partial paraplegia to actually walk in their homes and communities.

We have seen amazing advances in technology in recent years. These advances make it possible for manufacturers to address longstanding disabilities in innovative ways. That said, we will continue to acknowledge that all medical therapies have benefits as well as risks. So, when making regulatory assessments, we’ll make every effort to make sure our decisions are balanced, and to ensure that approved or cleared devices can aid the patients who use them.

In addition to helping patients across the country, we are committed to empowering agency employees. For instance, FDA Commissioner Margaret A. Hamburg, M.D., recently held a meeting with the agency’s Advisory Committee for Employees with Disabilities (ACED). There, the committee provided an annual update and discussed topics that impact employees with disabilities, including making sure all buildings are accessible and facilitating access to assistive and adaptive technologies through a new Ergonomic Resource Center at our headquarters. And this month the committee held an additional, internal roundtable event to focus on continued awareness, timed to National Disability Employment Awareness Month.

People with disabilities make many important contributions to our agency and to society at large. It’s our goal and commitment to help them maintain an active lifestyle and enjoy a good quality of life.

William Maisel, M.D., M.P.H., is FDA’s Deputy Center Director for Science and Chief Scientist for its Center for Devices and Radiological Health.

No Longer In the Dark

By: William Maisel, M.D., M.P.H.

We take so much for granted.

William Maisel, M.D., M.P.H.That was my thought when I first heard about the Argus II Retinal Prosthesis System, a new device approved by the FDA today.

This small electronic device, implanted in the eye, may improve the visual function of patients with advanced retinitis pigmentosa, or RP.

What is RP? It’s a rare genetic eye disease that affects approximately 100, 000 people in the U.S. RP gradually damages the light-sensitive cells that line the retina (a membrane within the eye). In time, a person’s limited ability to tell light from dark can erode. Far too often, the outcome is total blindness.

After carefully reviewing data from a clinical study of 30 patients with RP, FDA is giving the go-ahead to Second Sight Medical Products Inc. to sell the Argus II, the first device of its kind. It has three components: a small electronic device surgically implanted in the eye, a tiny video camera mounted on a pair of glasses and a control unit that is carried by the patient.

The camera captures images. The images become an electric signal. The brain perceives this signal as light.

I could say a lot about how this device works and what it can do for those with RP, but instead, I’ll let patients from the study speak for themselves. Here are excerpts from their comments at the public forum of FDA’s advisory meeting:

“The biggest thing to me was being able to see the crosswalk lines on the street so I can safely cross streets in Manhattan.”

“The most exciting day to me was October 27th, in 2009. It was the first time I was able to see letters on the monitor screen (during a test of visual perception). I had not seen letters since 1994, so that was huge.”

“I have a son who is 17 years old and … I don’t mind telling you how much — I mean, how happy that made me, not only to see the silhouette of my son, but to hear that voice coming and saying, ‘Yeah, it’s me, Dad. I’m here and I love you.’ ”

For many of the approximately 1,300 individuals who will develop the disease this year, this technology may change their lives. And FDA, on the cutting edge of regulatory science, played an important role in that.

It’s the difference between night and day.

William H. Maisel, M.D., M.P.H., is Deputy Director for Science and Chief Scientist at FDA’s Center for Devices and Radiological Health