Medical Device Daily
Foot drop — for such a simple-sounding name the condition is anything but simple.
A condition commonly following central nervous system trauma, injury, stroke or other disease that results in weakness or paralysis of muscles in the lower leg, foot drop causes instability, diminished walking speed, and increases the risk of falling.
Now, a new wireless device from Bioness (Santa Clarita, California), designed to improve gait in people suffering from foot drop, is gaining traction in the world of physical therapy.
While the majority of patients who could benefit from the Ness L300 are stroke patients, Todd Cuschman, VP of business development at Bioness, told Medical Device Daily the device also offers hope for patients suffering from traumatic brain injury, multiple sclerosis and cerebral palsy.
The NESS L300 is a three-part device — an electronic orthosis that wraps around the knee, an Intelli-Sense Gait Sensor placed under the heel, and a control unit. Together they detect and transmit foot placement and provide synchronized electrical stimulation to the targeted muscles and nerves to stimulate dorsiflexion of the foot, giving toe clearance during the swing phase of ambulation, thus improving gait and lessening the likelihood of tripping, according to Bioness.
The L300 also has a built in sensor that recognizes the surface the patient is walking on and adjusts accordingly. There are no bulky wires to deal with and the compact design even allows patients to wear their normal footwear, the company said.
“The materials are very light and very breathable and that was a very important parameter in the design of this technology because patients will wear this for eight to 10 or 12 hours a day so it had to be very comfortable,” Cushman told MDD.
Cushman said age is not a factor in whether or not a patient would benefit from using the L300, but their activity level and desire to regain their independence is.
“Like any therapeutic device ... a lot of it’s going to depend on the individual patient and their drive to regain their independence and mobility,” Cushman said.
Amit Dar, head of R&D at Ness (Ra’anana, Israel), showed the Ness L300 at the second Israel Summit, held in Haifa, Israel, in March (MDD, April 23, 2007). Ness and Bioness reported a planned merger in April (MDD, April 2, 2007).
Bioness was established in 2004 by the well-known medical device entrepreneur Alfred Mann, the Alfred E. Mann Foundation for Scientific Research, and Ness.
Cushman noted a number of different breakthrough technologies that Mann has made, including the first battery-powered pacemaker, which is now a St. Jude Medical (St. Paul, Minnesota) device.
“He’s a very dynamic individual and very well-known in the surgical device world,” Cushman said, an understatement to MDD readers who find his name in these pages quite often, most recently in the multi-million-dollar recapturing of the assets of Advanced Bionics (Valencia, California), a company he helped to found, from Boston Scientific (Natick, Massachusetts) (MDD, Aug. 13, 2007).
According to the company, many well-known hospitals have integrated the technology into their rehabilitation programs “and seen a tremendous success,” since the device became available about a year ago.
An example of that success, Bioness said, is being demonstrated at Shepherd Center (Atlanta) where the technology is used and patients are benefiting from the device.
The L300 uses what the company bills as Functional Electrical Stimulation (FES). In addition to facilitating a more fluid gait, the L300 may also stimulate muscle re-education, prevent/retard disuse atrophy, maintain or increase joint range of motion and increase blood flow, Bioness said.
Even patients who have suffered a stroke but are no longer in physical therapy could benefit from using the L300, Cushman said.
“Our challenge is getting the word out to the folks who could benefit that are not in therapy at this time,” Cushman said.
Bioness also has a similar device on the market, the H200, designed to help patients regain mobility in their hands. Cushman said the H200, which is worn on the forearm and hand, is based on the same technology as the L300 using FES, which allows the patient to open and close the hand, reduce stiffness, increase range of motion and strength, improve circulation and assist in regaining awareness of an impaired limb.
But perhaps the best is yet to come for Bioness.
Cushman said that the company is working on a device that would make all the technology that patients now wear outside of the body implantable.
“We’re using wireless technology, microelectronics and we’re making a very small implant which we have right now in an FDA study, and we look forward to commercializing that product in the upcoming years,” Cushman told MDD.
Like much new technology, the company is still in development phase, and Cushman said he could not give an estimated timeline for when the product might be available. But, he said, “It’s a top priority at Bioness.”