RHCI First in Country To Offer Breakthrough Technology To Improve Walking after Stroke

News Release
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How the NESS L300™ Works
Referrals
Guidelines for Physicians

NESS L300™ Corrects Foot Drop
Rehabilitation Hospital of the Cape and Islands is the first hospital in the United States to offer treatment with the NESS L300™ neuro-rehabilitation system. The NESS L300 is a revolutionary device that improves walking ability, daily function and quality of life in people experiencing foot drop.

Foot drop is a common result of:

•   Stroke
•   Brain injury
•   Multiple sclerosis
•   Cerebral palsy
•   Brain tumors
•   Incomplete spinal-cord injuries
•   Other discorders of the central nervous system

Treatment with the NESS L300™ and physical therapy can improve or restore the patient’s gait, resulting in greater speed, balance, stride and a more normal gait pattern – and eliminating the need for a rigid foot brace. This innovative wireless technology can enhance mobility for people even years after their stroke.

How It Works
The NESS L300™ neurorehabilitation system includes three components that communicate with each other via wireless technology to coordinate walking. The device delivers electrical stimulation to specific nerves which control the movement of muscles that cause the foot to flex and the toes to rise as the person walks.

The system includes:

• A comfortable Orthosis which wraps around the leg just below the knee. It contains the electrodes that provide the electrical stimulation.
• The Intelli-Sense Gait Sensor, which fits inside a regular shoe. It automatically adjusts the person’s gait based on speed, rhythm and different surfaces.
• Small Control Unit which “talks” to the other components to promote a more normal walking pattern. The control unit is programmed by the physical therapist to meet each patient’s specific needs.

Key Features of the NESS L300™:

• Electrical stimulation causes the toes and ankle to flex to prevent foot drop
• Wireless system for ease of use
• Ergonomic design promotes comfort and optimal fit
• Frees the ankle to promote better movement over uneven surfaces
• Easy to put on and take off
• Facilitates neuromuscular re-education
• Improves range of motion
• Increases blood flow
• Reduces disuse atrophy, swelling, spasticity, pain

Referrals

RHCI Provides:

• Therapists with specialized training
• Inpatient treatment to accelerate return of function
• Outpatient evaluations for patients with new or prior foot drop (physician referral required; see Guidelines for Physicians)
• Outpatient therapy that incorporates the NESS L300™
• Instruction for a home use program

Evaluations and information:
Specially trained outpatient physical therapists evaluate people with foot drop due to recent and prior neurological disease and injury to determine if they are appropriate candidates to try the device. The NESS L300™ can be incorporated into ongoing physical therapy in the outpatient clinic setting. It is also intended to be used at home and in the community to improve mobility and to promote neuromuscular reeducation. The NESS L300™ can improve walking ability for people even years after a stroke or other neurological injury.

A physician’s referral is required for evaluation and treatment. For referral guidelines for physicians, click here.

Scheduling an Evaluation

• Outpatient Evaluations in Sandwich (508) 833-4141
• Outpatient Evaluations in Orleans (508) 240-7203

The L300 is the companion of the successful NESS H200 hand neuro-prosthesis, which has enabled thousands of patients in the U.S. and Europe to regain the use of paralyzed and weakened hands. RHCI began using the H200 in 2005. Treatment with this advanced technology is offered at RHCI through the hospital’s Center for NeuroRecovery.

Guidelines for Physicians
RHCI Referral Guidelines for Physicians
NESS L300™ Neuroprosthesis

Diagnoses:

• Stroke
• Traumatic Brain Injury
• Brain Tumor
• Cerebral Palsy
• MS, Other Neurological Disorders
• Incomplete Spinal Cord Injury

Contraindications:

• Demand-type cardiac pacemaker, defibrillator; electrical or metallic implant
• A cancerous lesion, present or suspected, in the area of the orthosis
• Areas of regional disorders, such as a fracture or dislocation, which would be adversely affected by motion from the stimulation
• Swollen, infected or inflamed areas or skin eruptions (e.g., thrombophlebitis, cellulitis, varicose veins, etc.) where the orthosis would be applied

Precautions:

• The safety of using the NESS L300 during pregnancy has not been established
• Caution should be used in patients with:
  • Suspected or diagnosed heart problems
  • Suspected or diagnosed epilepsy
• If the following conditions are present in the area of the orthosis: acute trauma or fracture; recent surgical procedures when muscle contraction may disrupt healing; over areas of the skin that lack normal sensation.
• Specific physician clearance should be obtained prior to use for patients with:
  • Alteration of normal arterial or venous flow in the region of the orthosis due to local insufficiency or occlusion, arterio-venous fistula related to hemodialysis, primary disorder of vasculature
  • Structural deformity in the area to be stimulated

Making the Referral
Patient requires a physician's order for evaluation/treatment. Please specify treatment with the NESS L300 and indicate functional deficit(s) to be addressed:

• Improve gait/reduce foot drop
• Increase range of motion
• Increase blood circulation
• Prevent disuse atrophy
• Neuro-muscular re-education
• Pain management
• Reduce spasticity; tone management
• Joint contracture prevention/treatment
• Post-Botulinum Toxin injections (without Baclofen pump)

Contact

• Outpatient Evaluations (508) 833-4141
• RHCI-Sandwich Clinical Coordinator, Laurie Crocker, PT (508) 833-4146
• RHCI-Orleans Clinical Coordinator, Jennifer Avery, PT (508) 240-7203
• Inpatient Clinical Coordinator, Dawn Lucier, PT (508) 833-4262

News Release
BIONESS & REHABILITATION HOSPITAL OF THE CAPE AND ISLANDS LAUNCH BREAKTHROUGH NEURO-REHABILITATION TECHNOLOGY
NESS L300™ System Helps Restore Lost Mobility and Independence among
Patients with Stroke and Other Neurological Conditions

February 1, 2007
SANDWICH, MA — Bioness, Inc. and the Rehabilitation Hospital of the Cape and Islands (RHCI) have jointly launched in the U. S. the NESS L300™ — a revolutionary neuro-rehabilitation system that restores lost mobility and independence among patients with stroke and other neurological conditions.

RHCI, the first hospital in the country to incorporate this breakthrough technology into its rehabilitation programs, will serve as a regional evaluation and treatment center for patients interested in trying out the new device. In addition to stroke survivors, individuals suffering from brain injuries, multiple sclerosis, cerebral palsy, brain tumors, and incomplete spinal-cord injuries can also benefit from the L300.

Central nervous system injuries often result in foot drop, leading to instability and difficulty walking. Utilizing a proven therapeutic modality – Functional Electrical Stimulation (FES) – the NESS L300™ helps patients experiencing foot drop to regain mobility and help “normalize” walking and gait [click here to see how it works ]. The L300 uses wireless communication to “talk” to its components, eliminating cumbersome wires and other limitations of previous FES systems that made them impractical to use.

“I stand before you with exciting and exhilarating news because today RHCI and Bioness are formally introducing an advancement in rehabilitation technology that we believe truly has the potential to transform lives,” said David M. Lowell, M.D., a neurologist and RHCI’s medical director. By controlling foot drop, the device normalizes the person’s gait and eliminates the need for the ankle-foot brace, he noted. “One patient said ‘I’ve walked like a turtle for six years. Now I’m walking more freely.’”

Dr. Lowell noted that RHCI has incorporated the neuroprosthetic system into both inpatient and outpatient settings. The system complements traditional therapies and gives therapists new options for doing higher level therapy quicker. “The therapist can put the L300 on a stroke survivor and help the patient walk in a special harness days after a stroke. That’s truly amazing,” said Dr. Lowell.

RHCI currently has ten NESS L300™ units: six for inpatient use, two for outpatient use in Sandwich, and two at the RHCI-Orleans Outpatient Rehabilitation Center. RHCI expects to make two additional units available at its Yarmouth facility in the near future. Bioness is in the process of manufacturing units for home use.

Persons interested in being evaluated for using the NESS L300 may call RHCI at (508) 833-4141. They will need a referral from their physician.

RHCI is a 60-bed, acute rehabilitation hospital in Sandwich, Massachusetts. It is affiliated with Massachusetts General, Brigham and Women’s, and Spaulding Rehabilitation Hospitals and is a member of Partners HealthCare System, Inc. RHCI provides inpatient and outpatient rehabilitation care to residents of the Cape, Islands, South Shore, and South Coast regions. In 2005, RHCI established the Center for NeuroRecovery, which includes its Stroke Program, Brain Injury Program, and Parkinson’s Disease Program.

California-based Bioness Inc. was formed in 2004 by the Alfred Mann Foundation for Scientific Research, a world leader in medical technology, and NESS Ltd., a company headquartered in Israel that develops and manufactures neuroprosthetic and rehabilitation systems. Bioness Inc.’s mission is to deliver innovative devices and therapies to the field of physical medicine, taking rehabilitation to new levels of physical independence and productivity. Release of the L300 follows introduction of the NESS H200™ [click here for information ], another Bioness rehabilitation system, which is designed to advance upper extremity rehabilitation. RHCI has been using the NESS H200 since 2005. To learn more about Bioness Inc. or the L300, please visit www.bioness.com.