May 13, 2011 — The US Food and Drug Administration (FDA) has given 510(k) clearance to the NESS L300 Plus System (Bioness Inc), which facilitates walking in patients with stroke or central nervous system disorders.
According to the manufacturer, the NESS L300 Plus device stimulates knee flexion and extension along with ankle dorsiflexion during each step. The system includes a wireless, software-driven functional electrical stimulation system that targets the peroneal nerve with low levels of electrical stimulation to enable foot dorsiflexion and facilitate motor recovery.
A wireless heel sensor detects gait variations while navigating uneven surfaces and changes in elevation and walking speeds. Together with a synchronized thigh stimulation cuff, this device controls the knee and facilitates walking.
The system is indicated for patients with a motor deficit in the lower limb(s) caused by conditions such as stroke, multiple sclerosis, traumatic brain injury, or spinal cord injury. Historically, rigid plastic braces that restrict thigh and ankle movements have been used. However, these can lead to additional problems, such as loss of range of motion.
Patients with central nervous system injuries or diseases are often affected by gait movement disorders, such as foot drop, which results from partial leg paralysis that prevents the foot from lifting. In addition to making walking difficult, gait movement disorders may also lead to mental and physical fatigue, falls, or abnormal walking patterns that can result in additional injury.
"An estimated 12.5 million Americans live with the effects of central nervous system injuries and disorders, and many of these individuals have gait disorders that make it difficult if not impossible for them to walk with freedom," noted Thomas G. Fogarty, president and chief executive officer of Bioness Inc, in a written release.
"The NESS L300 Plus will provide physical therapists an additional modality to optimize the patient's course of therapy and allow home users better control over their knee and foot, making it easier to walk," he adds.
The company anticipates that the NESS L300 Plus system will be commercially available to both neurorehabilitation hospitals and to patients for home use within the next few weeks.
According to the manufacturer, the NESS L300 Plus device stimulates knee flexion and extension along with ankle dorsiflexion during each step. The system includes a wireless, software-driven functional electrical stimulation system that targets the peroneal nerve with low levels of electrical stimulation to enable foot dorsiflexion and facilitate motor recovery.
 |
| NESS L300 Plus device |
The system is indicated for patients with a motor deficit in the lower limb(s) caused by conditions such as stroke, multiple sclerosis, traumatic brain injury, or spinal cord injury. Historically, rigid plastic braces that restrict thigh and ankle movements have been used. However, these can lead to additional problems, such as loss of range of motion.
Patients with central nervous system injuries or diseases are often affected by gait movement disorders, such as foot drop, which results from partial leg paralysis that prevents the foot from lifting. In addition to making walking difficult, gait movement disorders may also lead to mental and physical fatigue, falls, or abnormal walking patterns that can result in additional injury.
"An estimated 12.5 million Americans live with the effects of central nervous system injuries and disorders, and many of these individuals have gait disorders that make it difficult if not impossible for them to walk with freedom," noted Thomas G. Fogarty, president and chief executive officer of Bioness Inc, in a written release.
"The NESS L300 Plus will provide physical therapists an additional modality to optimize the patient's course of therapy and allow home users better control over their knee and foot, making it easier to walk," he adds.
The company anticipates that the NESS L300 Plus system will be commercially available to both neurorehabilitation hospitals and to patients for home use within the next few weeks.
No comments:
Post a Comment