Medical Device Daily Washington Editor

NovaVision (Boca Raton, Florida) is quickly expanding the network of medical centers offering its Vision Restoration Therapy (VRT) system.

The latest facility to offer the vision restorative device therapy to patients is the Albert Einstein Medical Center (New York), a not-for-profit organization with facilities and outpatient centers in the Philadelphia area.

“Albert Einstein’s department of neuro-ophthalmology is a nice fit within NovaVision due to the patient volume that they see and the patient base that has the vision deficits that NovaVision treats,” Rob Doll, vice president and chief operating officer for NovaVision told Medical Device Daily.

The Albert Einstein Medical Center also includes MossRehab, which treats more stroke patients than any other rehabilitation facility in the Philadelphia region and has consistently rated as one of the nation’s best medical rehabilitation facilities by U.S. News & World Report, according to NovaVision.

VRT is a non-invasive, computer-based treatment designed to help restore vision lost as a result of stroke or traumatic brain injury (TBI), a condition previously considered untreatable.

The system was cleared by the FDA in April 2003, and is intended for the diagnosis and improvement of visual functions in patients with impaired vision that may result from trauma, stroke, inflammation, surgical removal of brain tumors or brain surgery, and may also be used in patients with amblyopia.

The technology currently is offered via a network of 14 clinics to date, but that number will be expanding, Doll said.

“Our goal is to roll this out nationally, to reach more facilities and patients across the U.S.,” he explained, noting that expansion up until this point has been more gradual. “We are rolling out as quickly as we can to other centers [that] would like to use the technology.”

NovaVision previously had focused on markets on the East Coast, closer to its headquarters, Doll said. The push now has been to expand the reach of the technology. NovaVision has been careful to ensure that the company’s growth hasn’t outpaced its ability to adequately serve its current list of client centers, Doll said.

Doll told MDD that the company also recently completed a multi-center deal to provide VRT technology through the Sharp Healthcare network in San Diego.

“You’ll be seeing more centers come on board faster,” Doll added.

He said that the company has been focusing on a strategy that targets neuro-ophthalmology centers and stroke and rehabilitation facilities.

In addition to providing the technology, NovaVision helps participating centers with marketing and sales support. Company representatives contact physicians surrounding VRT-affiliated centers to provide information about the therapy so they are able to refer patients for treatment.

The company also provides “a multifaceted patient and physician education program,” Doll said.

VRT is based on the principle of neuroplasticity, which is the ability of partially damaged neurons in the brain to compensate for injury and adjust their activity in response to stimulation from the environment.

After stroke or TBI, a zone of residual vision exists between regions within the brain’s vision-processing areas. Within this zone, there are areas that can be improved using precise patterns of stimulation.

Following a clinical assessment and diagnosis at centers such as Albert Einstein Medical Center, VRT is conducted in the patient’s home on a device that looks like an ordinary laptop computer connected to a chinrest.

The patient performs a customized therapy that displays stimuli – flashing colored dots – on the computer screen. The stimuli are focused on areas between the patient’s area of good and poor vision to stimulate the areas where they are not seeing well.

According to the company, the patient responds to each stimulus while focusing on the fixation point displayed by pressing a button. Repeated exposure over an initial treatment period of roughly six to seven months for a total of an hour a day “may activate neurons and help improve vision, with some patients showing improvements within a couple months of beginning therapy,” NovaVision says.

The only side effects associated with the therapy are headache and fatigue, the company said.

Clinical studies have shown that more than 65% of patients have exhibited improvement in their vision after completing the initial six months of therapy, the company said.

Doll calls VRT the “fourth pillar of rehabilitation” along with speech, physical and occupational therapies. He compares the process to the physical therapy that most people are familiar with, where therapists force patients not to use a good arm or leg and focus on the side affected by the stroke. VRT therapy trains patients to use a field of vision they have not been using.

“[Patients] are able to read now, they bump into things less, walk unaided, and are able to do hobbies again,” Doll said. “Patients have been told for years that nothing can be done, and now their doctors are saying that something can be done and patients are seeing improvement.”

The therapy also does not depend on how long a patient has had vision problems. Some VRT patients have experienced vision improvement even after 20 years, Doll said.

“Historically we have always felt that people who have visual field deficits perhaps due to stroke or brain injuries get whatever recovery they get and that’s it and there’s nothing else we can do,” Mark Moster, MD, chairman of the division of neuro-ophthalmology at Einstein Medical Center and professor of neurology at Thomas Jefferson University School of Medicine, told MDD. “But for the first time there is some evidence that we can actually have recovery of what was felt to be unrecoverable visual field. It is much better than we ever had. ”

The total price of therapy is determined by each NovaVision partner clinic, but the six-month VRT cost – including leasing the computer device – is roughly $6,000. Some insurance plans may pay for part of the therapy, and Medicare covers some office visits and initial costs.

About 1.5 million stroke and TBI victims in the U.S. suffer from major visual field deficits, and that number grows by more than 90,000 new patients a year, according to the company. It reports that about 700 patients have been treated with VRT.