Posts Tagged Bioness
[WEB SITE] Bioness Receives FDA Clearance for myBioness™ iOS app for mobile control of the L300 Go™ System
VALENCIA, Calif., March 26, 2018 /PRNewswire/ — Bioness, Inc., the leading provider of cutting-edge, clinically supported rehabilitation therapies, today announced that it received clearance from the U.S. Food and Drug Administration (FDA) for the myBionessTM mobile app for use with the L300 Go™ System.
The new myBioness™ mobile iOS application allows home users to control their L300 Go system including ability to change stimulation modes between gait and training along with adjusting personal pre-set intensities to meet their daily activity demands. The app has been designed to keep users engaged in the rehabilitation process and motivated to meet their recovery goals with ability to track activity, set personal goals and review their progress over time using dynamic reporting capabilities.
Gait movement disorders, such as foot drop and knee instability, are often associated with an upper motor neuron disease such as stroke and multiple sclerosis as well as injuries to the brain and spinal cord. Individuals with an impaired gait have less control over their lower extremity muscles and are at an increased risk for falls. The L300 Go is the first functional electrical stimulation (FES) system to offer 3D motion detection of gait events and muscle activation using data from a 3-axis gyroscope and accelerometer. Patient movement is monitored in all three kinematic planes and stimulation is deployed precisely when needed during the gait cycle. An adaptive, learning algorithm accommodates changes in gait dynamics, and a high speed processor that deploys stimulation within 10 milliseconds of detecting a valid gait event. This rapid, reliable response is critical and supports user confidence.
“Technological innovations including 3D motion detection and multi-channel stimulation work together to improve treatment efficiency and promote patient mobility,” said Todd Cushman, President and CEO of Bioness. “At Bioness, we are focused on improving the lives of patients through technology and are proud to add the myBioness mobile application to the L300 Go portfolio of products.”
The L300 Go System was cleared by the U.S. Food and Drug Administration on January 27, 2017 with formal approval of the upgraded mobile application clearance dated March 9, 2018. The system is indicated to provide ankle dorsiflexion in adult and pediatric individuals with foot drop and/or assist knee flexion or extension in adult individuals with muscle weakness related to upper motor neuron disease/injury (e.g., stroke, damage to pathways to the spinal cord). The L300 Go System electrically stimulates muscles in the affected leg to provide ankle dorsiflexion of the foot and/or knee flexion or extension; thus, it also may improve the individual’s gait.
Bioness will begin commercial release of the myBionessTM mobile app in the spring of 2018. The L300 Go Systems are commercially available since the summer of 2017.
About Bioness, Inc.
Bioness is the leading provider of innovative technologies helping people regain mobility and independence. Bioness solutions include implantable and external neuromodulation systems, robotic systems and software based therapy programs providing functional and therapeutic benefits for individuals affected by pain, central nervous system disorders and orthopedic injuries. Currently, Bioness offers six medical devices within its commercial portfolio which are distributed and sold on five continents and in over 25 countries worldwide. Our technologies have been implemented in the most prestigious and well-respected institutions around the globe with approximately 90% of the top rehabilitation hospitals in the United States currently using one or more Bioness solution. Bioness has a singular focus on aiding large, underserved customer groups with innovative, evidence-based solutions and we will continue to develop and make commercially available new products that address the growing and changing needs of our customers. Individual results vary. Consult with a qualified physician to determine if this product is right for you. Contraindications, adverse reactions and precautions are available online at www.bioness.com.
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Published on August 30, 2017
Bioness announces it has begun shipping the L300 Go Systems, cleared by the FDA in early 2017 and available in four configurations for use in patients with foot drop and/or muscle weakness related to upper motor neuron disease/injury.
The L300 Go System succeeds the NESS L300 Foot Drop System and NESS L300 Plus System, and includes numerous advancements designed to optimize therapy sessions and promote functional gains at home.
Among these is comprehensive 3D motion detection of gait events, via a learning algorithm that analyzes patient movement and offers electrical stimulation precisely when needed during the gait cycle.
Additional features, according to a media release from Valencia, Calif-based Bioness, include adaptive motion detection and onboard controls that eliminate dependence on foot sensors or remote controls; multi-channel stimulation, which enables clinicians to adjust dorsiflexion and inversion/eversion with a novel new electrode options; and myBioness, a new mobile iOS application designed to empower home users to extend rehabilitative gains through setting goals and tracking recovery progress.
“Today’s value-based healthcare model demands that rehabilitative professionals keep patients motivated through superior, more personalized care,” says Todd Cushman, president and CEO of Bioness, in the release. “With the introduction of the L300 Go, clinicians now have access to technological innovations that keep patients engaged during the recovery process while improving mobility in the clinic and community.”
Current users of the L300 Foot Drop System and the L300 Plus System will be eligible for a Customer Loyalty Upgrade Program, which is designed to make the L300 Go more accessible for users in the clinic and community.
[Source(s): Bioness, PR Newswire]
[WEB SITE] Bioness Announces Commercial Availability of the L300 Go™ System to Healthcare Professionals
The L300 Go System, which received FDA clearance in January, has now received the CE Mark in the European Union.
The next step for Valencia, Calif-based Bioness Inc will be to make the L300 Go System available to healthcare professionals and home users in Europe.
The functional electrical stimulation (FES) system is built to help increase mobility in individuals with lower limb paralysis or weakness.
Features include 3D motion detection of gait events from a 3-axis gyroscope and accelerometer, which detects movement in all three kinematic planes; as well as the myBioness mobile iOS application that allows users to track their progress, set goals, and evaluate their movements.
“We are pleased to have achieved this important regulatory milestone,” says Todd Cushman, president and CEO of Bioness, in the release. “The market response to the technology after its debut in February has far exceeded our expectations as clinicians realize how the L300 Go can improve clinical efficiency and facilitate superior patient care.”
The L300 Go System will be available to European users sometime in late summer 2017, per the release.
[Source(s): Bioness Inc, PR Newswire]
Regain More Natural Hand Function — With Wireless Freedom.
The H200 Wireless Hand Rehabilitation System
Now you can get back to your daily living activities with the H200 Wireless Hand Rehabilitation System that offers the freedom and convenience of wireless operation. The H200 Wireless Hand Rehabilitation System is an ergonomically designed, easy-to-operate system that helps you achieve your personal recovery goals. Reaching, grasping, opening and closing the hand are all possible with the H200 Wireless Hand Rehabilitation System.
With wireless operation, it’s easy to integrate into your daily life.
The system’s advanced technology delivers low-level electrical stimulation to activate the nerves that control the muscles in the hand and forearm, helping you regain your freedom and independence.1
The H200 Wireless Hand Rehabilitation System is a medical device cleared by the U.S. Food and Drug Administration (FDA) and CE-marked for the European Union.
If you are currently a H200 Hand Rehabilitation System user, Bioness will continue to support your current system through April 2014. However, to help you upgrade to the new H200 Wireless System, we are offering a substantial trade-in allowance for your current system for a limited time.
1. Hausdorff JM, Ring H. 2006. The effect of the NESS L300 neuroprosthesis on gait stability and symmetry (abstract included in CSM 2007 Platform Presentations). J Neurol Phys Ther. 30(4):198.
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Regain Independence, Function, and Mobility.
Regain function with Bioness’ innovative solutions designed to help those living with Foot Drop or Hand Paralysis due to conditions such as Stroke, Multiple Sclerosis, Cerebral Palsy, Traumatic Brain Injury, or Incomplete Spinal Cord Injury.
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In the rehabilitation world, there are a number of approaches to manage the physical sequelae that occur post-stroke. One of those sequelae is foot drop, which is most common among the impairments characteristic of post-stroke patients, and experienced by an estimated 20% of all stroke survivors.1 Since foot drop affects ability to safely ambulate throughout the home and community, retraining the impaired muscles that contribute to foot drop becomes a priority. Lower-extremity bracing is one measure that can be used to manage foot drop. Correctly timing the decision to fit a patient with a brace or other orthosis has been heavily discussed in the literature, and understanding the considerations that can help pinpoint that optimum time are explored in this article.
Multidisciplinary Expertise is Essential
At the Kessler Institute for Rehabilitation, patients affected by stroke are seen for initial bracing evaluations during the inpatient and outpatient phases of recovery. They are also reassessed as needed throughout the continuum of care. For some patients, a brace or orthosis for daily use may be prescribed. In such cases, a team of rehabilitation professionals is called on to participate in the decision-making process.
The team physician leads the decision-making process and is ultimately responsible for determining which orthotic best suits the patient’s needs. The physical therapist assists with the bracing decision-making process by contributing gait analysis expertise. An orthotist designs and fabricates an ankle-foot orthosis (AFO) when prescribed, provides expertise in biomechanical gait principles, and integrates that expertise with orthotic-based materials. The patient/caregiver provides feedback for discussion among the other team members and ultimately makes the decision about bracing based on recommendations made by the team.
Other factors weighed during the decision-making process for bracing include limited insurance or financial restrictions put on custom bracing, limited access to an orthotist, and likelihood of compliance.
Making the decision about the optimal point in time to fit a patient with an orthosis is multifactorial. This decision can be dependent on discharge disposition with particular regard to whether the patient is discharging to home, and if safety is a primary concern secondary to a lack of ankle control. The level of impairment as well as weakness and instability should be taken into consideration, coupled with any prognostic indicators for a positive return in muscle control.
Many variables can account for how an AFO can improve walking endurance and functional ambulation long-term among patients affected by chronic stroke. For example, the AFO will create ankle joint stability and enhance foot clearance through swing phase of gait. This will alter gait mechanics and ultimately help to enhance the patient’s confidence in their own gait ability. An AFO preserves first ankle rocker with hemiplegic patients and provides a more efficient weight acceptance at initial contact to allow for enhanced double limb support and, thus, increased gait speed.2 Gait efficiency is also an important factor to consider when discussing energy expenditure and a patient’s ability to perform functional ambulation. Dynamic AFOs were shown to decrease energy cost of walking, as demonstrated from the Physiological Cost Index when compared to shoes only with chronic stroke patients.3
Comparing Braces and Orthoses
There are important pros and cons for each type of orthosis, with cost and weight the two most common factors. Also, there are drawbacks generally associated with the use of an orthosis that include compliance secondary to comfort, limited ankle motion, and a relatively fixed position (unless an articulating AFO is prescribed).
Part of the decision about bracing may come down to trade-offs between a customized AFO and an “off the shelf,” prefabricated brace. The advantages each confers are distinct. For example, a custom molded AFO offers the ability to create an optimal fit and provides maximum control of the limb. In contrast, while mass-produced prefabricated orthoses may sacrifice quality of fit and limb control, they can be used as an evaluative tool or a short-term fix during the rehabilitation process.
The conventional double upright AFO is another common bracing solution that may require review by the multidisciplinary team. This design is used when there is significant or fluctuating edema that may constrict the limb and present pressure-related issues with the fit of an AFO. An articulating (hinge) AFO is used to assist with continued dorsiflexion and allow for great ankle ROM. It is not appropriate if spasticity is present, and can be challenging for shoe wear because width is typically wider to accommodate joint of brace.
Carbon composite AFOs are a dynamic bracing option that allow for push-off during third (forefoot) ankle rocker of gait. These AFOs are made to keep the foot up during swing phase, and provide a soft heel strike and stability in stance. This type of brace is contraindicated for patients affected by significant edema, ulcers, and spasticity. Several types of carbon composite AFOs are offered by Allard USA, Rockaway, NJ, including the ToeOFF, ToeOFF Short, BlueROCKER, KiddieROCKER, KiddieGAIT, and Ypsilon. Each brace in this carbon fiber AFO product line is designed to offer specific benefits such as increased rigid orthotic control, size optimized to wearer’s stature, and to accommodate varying levels of spasticity.
Posterior Leaf Spring (PLS) is another common bracing option usually offered as a prefabricated product. The Superior C-90 from AliMed, Dedham, Mass, is an example of this type of brace, and built to provide a full range of plantar and dorsiflexion. The Superior C-90 also provides a thin trim line and allows for eccentric lowering of foot and dorsiflexion for tibial advancement over foot through mid-stance. One drawback to this design, however, is the lack of medial/lateral stability of ankle and poor knee control. It is also contraindicated for patients with spasticity and genu recurvatum or extensor thrust.
Functional Electrical Stimulation is an Option
Orthoses engineered to provide functional electrical stimulation (FES) to the wearer during use can be an alternative to traditional AFOs. The use of FES, particularly for lower extremity bracing, has been associated with increased gait velocity, decreased energy expenditure with gait, and improved gait symmetry. Two manufacturers that provide these devices include Reno, Nevada-based Innovative Neurotronics, which manufactures the WalkAide, and Valencia, Calif-headquartered Bioness, which manufactures the Bioness L300. Among the two products’ distinguishing structural characteristics, the WalkAide has a built-in tilt sensor while the L300 is designed with a heel switch sensor. Both products are considered FES devices, yet the mechanism of action used by each differs slightly.
At Kessler, the Bioness L300 is available for patients to trial. In my experience, and one of the advantages of using the L300, is the result in physiological changes such as increased muscle strength, improved volitional control, and increased joint range of motion. These changes indicate an increased therapeutic effect not associated with the use of traditional AFOs. Another advantage is highlighted in a study by Everaert et al that examined patient preferences for devices and revealed a statistical difference between patients who preferred to use the WalkAide versus an AFO.4 An additional benefit of using FES devices is a purported decrease in spasticity, which further improves the therapeutic effect.
There are some drawbacks associated with the use of an FES device, however, and the most common is cost. Third-party payors often decline coverage for FES devices, so the cost typically falls to the patient. The patient must also tolerate the stimulation so the motor nerve can be activated. Skin irritation is an undesirable side effect, and the wearer’s tolerance must be carefully monitored. Contraindications for these devices include demand-type pacemakers, any cancerous lesion, fractures, or dislocation. Cognitive impairment that could affect ability to use the device is another important consideration. Ultimately, the decision to use a brace as therapeutic treatment for foot drop is a collaboration with one goal: to improve a patient’s ability to safely ambulate and maximize functional independence. PTP
Farris Fakhoury, PT, DPT, has been a physical therapist in the Outpatient Neurologic Gym at Kessler Institute for Rehabilitation for 4 years, and is also the physical therapy lead for the facility’s amputee program. Fakhoury is the physical therapy lead for Kessler’s Amputees Coming Together (ACT) support group as well as for the Bioness program for outpatient services. He earned a bachelor of arts in psychology from Villanova University and a doctor of physical therapy from the joint program of Rutgers University/University of Medicine and Dentistry of New Jersey PT Program in Stratford, NJ. For more information, contactPTProductsEditor@allied360.com.
Rich Klager, PT, DPT, NCS, has been a physical therapist at the Kessler Institute for Rehabilitation in West Orange, NJ, for more than 8 years. His clinical practice experience expands over the Inpatient and Outpatient facilities in the neurologic population. He currently assists with the Outpatient orthotic clinic decision-making process with the Team Physician and Orthotist for patient bracing needs.
1. Bethoux F, Rogers HL, Nolan K, et al. Long term follow-up to a randomized controlled trial comparing peroneal nerve functional electrical stimulation to an ankle foot orthosis for patients with chronic stroke. Neurorehabil Neural Repair. 2015;29(10):911-922.
2. Nolan KJ, Yarossi M. Preservation of the first rocker is related to increases in gait speed in individuals with hemiplegia and AFO. Clin Biomech (Bristol, Avon). 2011;26(6):655-660.
3. Erel S, Uygur F, Engin Simsek I, Yakut Y. The effects of dynamic ankle-foot orthoses in chronic stroke patients at three-month follow-up: a randomized controlled trial. Clin Rehabil. 2011;25(6):515-523.
4. Everaert DG, Stein RB, Abrams GM, et al. Effect of foot-drop stimulator and ankle-foot orthosis on walking performance after stroke: A multicenter randomized controlled trial.Neurorehabil Neural Repair. 2013;27(7):579-591.
Lusardi MM, Jorge M, Nielsen CC. Orthotics and Prosthetics in Rehabilitation. St Louis: Saunders Elsevier, 2007.
[VIDEO] BIONESS 2015 North American Functional Electrical Stimulation for Walking Market Leadership Award – YouTube
[WEB SITE] The Latest Technology to Help You Walk More Naturally. What is the L300 Plus System? – Bioness Inc.
The L300 Plus System builds on the success of the L300 Foot Drop System by adding a thigh cuff to give you greater control over bending and straightening your knee, which may help you walk more naturally.
The L300 Plus System’s wireless components adapt to changes in walking speed and terrain, allowing you to walk more easily on stairs, grass and carpet. Comfortably worn under most clothing, the system’s unique design may help you eliminate the need for a rigid knee-ankle-foot orthosis (KAFO), or braces, and may reduce the risk of falls and injuries.
The L300 Plus System may also:
Reach for the latest breakthrough in hand rehabilitation. Regain the freedom of performing daily activities with the Bioness H200 Wireless Hand Rehabilitation System.
Advanced Technology to Help You Return to Your Daily Activities.
The H200 Wireless Hand Rehabilitation System Helps People Living With:
Stroke, Brain Injury, Spinal Cord Injury, and other disorders of the central nervous system resulting in functional deficits and impairments of the upper limb
The H200 Wireless Hand Rehabilitation System supports the wrist in a functioning position, allowing the fingers and thumb to move efficiently while reaching, grasping and pinching. This may allow you to regain hand function and get back to performing ordinary and essential activities of daily living. What’s more, the wireless model gives you the freedom to discreetly carry the Handheld Control Unit separately in your pocket, bag or purse.