By Frank Long

David Patterson, MD, says his patients — particularly stroke victims — are achieving “dramatic outcomes” in foot drop rehabilitation with the Bioness L300, a wireless technology newly developed for lower extremity treatment in use at only two locations in the United States.

Patterson hails the device’s ease of use and effectiveness in treating patients who have suffered traumatic brain injury, spinal cord injury and stroke. The exotic new system, he says, fundamentally changes best case scenarios for his patients at Casa Colina Rehabilitation Center in Pomona, Calif.

But at $5,900 per unit, some rehabilitation professionals question whether patients will be able to afford the device outside of the hospital, potentially excluding many from their fullest rehabilitation.

“It’s a fantastic device and it works very well,” Lexi Miles, MPT, physical therapist in the neuro outpatient facility at Froedtert and the Medical College of Wisconsin, Milwaukee, Wis., says. “But price is the number one negative and I think not a lot of people are not going to be able to use it in the home.”

The product’s manufacturer allows patients to rent the unit for $500 per month for up to four months when the payment is applied to the total purchase price. Miles says even the rental program will be too costly for many of her patients.

Mathu Hanson, clinical coordinator, outpatient neurology at Casa Colina, says price is a more moderate issue among his Southern California patients.

“Patients try it and they’re like kids in a candy store,” Hanson says. “It makes them feel like they’ve gained more independence and they get excited about it. You see their faces light up. They’re just happy it doesn’t look like a brace."

Since early January Hanson has treated more than 40 people with the new system. He says its wireless technology demands less staff involvement than previous technologies and estimates therapists save up to 20 minutes per application of stimulation.

“Things like body weight-supported treadmill running require fewer hands to manage the training because there are no wires or boxes or plugs.” Hanson says. “I feel like I have eight hands when I’m working with this device and I can do more of the activities I want, like functional training.”

In addition to being an effective rehabilitation tool, Hanson says because the unit can be applied with one hand patients will find it easy to use at home.

Miles agrees the L300 produces excellent results when matched with a specific type of patient, but says she also believes the price tag will restrict its use. “For someone who has a moderate amount of tone spasticity but is able to stretch their ankle close to neutral you know it’s going to work well. But you also know they probably won’t be able to afford the unit.” she says.

“You feel bad because you know there’s this technology out there that works but it’s not available because of the price.”

Though openly critical of its cost, Miles acknowledges that as a treatment technology the L300 delivers on its promise.

“At Froedtret we have a long history of working with electrical stimulation and because there was really nothing like this device previously I was a little skeptical until I was able to see it. I was hopeful, but skeptical. What we finally discovered was that paired with the right kind of patient it performs extremely well,” Miles concludes.

Patterson calls the wireless technology at the heart of the L300 "imperative" and says it legitimizes the device as a true advance in treatment.

“Products on the market years back that were not wireless impeded patient utilization and satisfaction. It was difficult for therapists to support that kind of product,” Patterson says.

Hanson agrees: "As the technology develops you can see one therapist being able to manage all the issues with a patient without having to use four of five staff members.”

Before the L300 became available domestically Patterson visited Bioness headquarters to tour the plant and speak with the company’s bioengineers. In conversation he discovered the device’s designers understood that patients who would be using the unit to treat the lower extremities would likely have functional impairments of upper the extremities.

“I, myself, am a therapist," Keith McBride, DTP and manager of clinical and technical support at Bioness, says. "Many members of the L300’s development team have therapist backgrounds. The device was developed by people who had a real awareness of the difficulties and limitations stroke and brain and spinal cord injury patients will experience,” McBride says.

Patterson characterizes the system as “intuitive.” He explains that inside the clinic the unit is controlled remotely by the therapist who uses a PDA to adjust the device’s parameters. The PDA contains a patient’s profile from which the therapist can check compliance and usage data, including the total number of steps taken by a patient between rehab appointments.

“Being able to show the data we’re able to collect with this system will be very useful if we’re ever going to get insurance companies to authorize payment,” Patterson says.

Patterson and Miles agree getting authorization from insurance companies for new devices can be problematic. “They’re cautious to authorize a product that may not be as clinically proven, but once it becomes clinically relevant they’ll have to address it,” Patterson says.

“I think Medicare is going to have to address the issue once they start to see the dramatic outcomes from this product,” he adds.

Hanson says he is committed to using the device despite its price and the reluctance of insurance companies.

“We’re seeing very good effects from it as a training and treatment tool,” Hanson says. “And outside of the unit’s cost it has more to do with giving patients the opportunity to develop selective control. It’s about how patient quality of life could potentially be improved by increasing their feeling of self-control over their own mobility.”