Posts Tagged FDA

[WEB SITE] This FDA Approved Drug Could Permanently Repair Brain Damage in Victims

In Brief
  • Using a drug already approved for clinical trials, researchers were able to reduce brain damage and boost the growth of new brain cells in mice suffering from strokes.
  • The research offers new hope to those dealing with the aftermath of strokes, which are the fifth leading cause of death in the United States.

Old Drug, New Treatment

Researchers from the University of Manchester have developed a new treatment that could limit the damage caused by strokes and also promote repair in the affected area of the brain. What’s more, the drug they’re using has already been clinically approved.

The researchers’ study is published in Brain, Behavior and Immunityand it recounts how they developed their treatment using mice bred to develop ischemic strokes, the most prevalent type of stroke and one that occurs when an artery that supplies oxygen-rich blood to the brain is blocked. Soon after the mice experienced a stroke, the researchers treated them with interleukin-1 receptor antagonist (IL-1Ra), an anti-inflammatory drug that is already licensed for use in treating rheumatoid arthritis.

They noticed a reduction in the amount of brain damage typically observed after a stroke and also noted that the drug boosted neurogenesis (the birth of new cells) in the areas that did experience brain damage in the days following the treatment. The mice even regained the motor skills they lost due to the stroke.

Hope for a Cure

Stroke is the fifth leading cause of death in the United States and about 800,000 people suffer from one each year, according to the Centers for Disease Control and Prevention (CDC). They occur when the flow of blood to the brain is interrupted, usually due to a blood clot or a buildup of fat that broke off from the arteries and traveled to the brain. The condition is extremely dangerous because brain cells can die within a few minutes of the stroke, causing permanent damage or even death.

We still don’t have a treatment to adequately prevent or reverse the damage to the brain caused by strokes, but the Manchester researchers believe that their development could change that. Though they are still in early stages of clinical trials, they hope to eventually move on to larger trials and eventually human testing. Together with other research, this new study offers hope to the thousands of people whose lives are impacted by strokes worldwide.

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[WEB SITE] FDA Approves WP-FES for Restorative Therapies’ RT300 FES Cycling System

Published on July 19, 2017

The US Food and Drug Administration has granted marketing clearance to Wide Pulse Functional Electrical Stimulation (WP-FES) for the RT300 cycling system from Restorative Therapies Inc.

This clearance allows Restorative Therapies Inc to begin marketing RT300 systems incorporating the new WP-FES functionality in the United States. It also allows the RT300 cycling system to be marketed for neuromuscular re-education in addition to its existing indications, according to a media release from Restorative Therapies Inc.

According to the Baltimore-based company, WP-FES provides wider stimulation pulses (up to 3,000 microseconds) to help recruit muscles in many patients who are normally less or not responsive to standard FES.

“This development will help to make FES cycling effective in a wider range of patients and help to facilitate clinical use of the latest therapy techniques improving outcomes for patients,” says Andrew Barriskill, CEO of Restorative Therapies, in the release.

“RT300 is the only FES cycling system that offers WP-FES and neuromuscular re-education,” adds Judy Kline, marketing manager at Restorative Therapies.

[Source(s): Restorative Therapies Inc, PRWeb]

Source: FDA Approves WP-FES for Restorative Therapies’ RT300 FES Cycling System – Rehab Managment

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[WEB SITE] Integration of FES Into G-EO System Gait Trainer Receives FDA Nod

Reha Technology USA Inc announces it now offers FDA-approved integrated Functional Electronic Stimulation (FES) for its G-EO System Evolution robotic gait trainer.

“The FES in conjunction with the G-EO System will allow clinicians to generate contractions in paralyzed or weakened muscles in lower extremities at the appropriate time in the walking cycle to maximize patient outcomes,” says Matthew Brooks, clinical director of Reha Technology USA Inc, in a media release.

The G-EO System robotic gait trainer provides passive and active, assistive and resistive training and the simulation of stairs walking up and down.

“We look forward to add this integrated FES feature to all of our current and future customers and we are confident that this extended offering will create added value for their therapy environment,” adds executive VP Paul Abrams, in the release.

[Source(s): Reha Technology USA Inc, PR Newswire]

Source: Integration of FES Into G-EO System Gait Trainer Receives FDA Nod – Rehab Managment

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[WEB SITE] FDA Clears SaeboVR Virtual ADL Rehabilitation System

SaeboVR, a virtual ADL (activities of daily living) rehabilitation system designed to provide real-life challenges to help neurological patients rehabilitate their upper extremities, has recently received clearance from the US Food and Drug Administration.

Manufactured by medical device company Saebo Inc, SaeboVR features an ADL-focused virtual world that provides patients with real-life situations challenging patients to use their impaired upper limbs to perform, such as picking up, transferring, and manipulating virtual objects. Recreations include making breakfast, taking care of a pet, or planting a virtual garden.

Additional features include a virtual assistant to educate users and provide feedback, as well as the ability to be customized to challenge patients’ endurance, speed, range of motion, coordination, timing, and cognitive demand.

After each session, SaeboVR displays graphical reports, according to a media release from Saebo.

The system was borne from National Institutes of Health-sponsored research demonstrating the efficacy of using virtual ADL to help rehabilitate the upper extremities.

“The release of SaeboVR culminates 5 years of NIH-sponsored R&D and successful clinical trials that have provided a solid body of evidence for the efficacy of simulated ADLs in improving upper extremity motor function in individuals with acquired brain injury,” says Richard Adams, PhD, from Barron Associates Inc, which has partnered with Saebo Inc to create the system.

SaeboVR opens new possibilities for clinicians and patients,” notes Saebo Inc’s co-founder, Henry Hoffman, per the release. “Prior to this break-through technology, motion capture programs were primarily focused on games rather than real-life functional tasks. Although computer-based exercises can be beneficial, often times, therapists report that games are not always appropriate for a certain patient population or lack significance to maintain a client’s motivation and engagement.”

[Source(s): Saebo Inc, PR Newswire]

Source: FDA Clears SaeboVR Virtual ADL Rehabilitation System – Rehab Managment

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[WEB SITE] Bioness Receives FDA Clearance for the L300 Go™ System.

VALENCIA, Calif., Feb. 07, 2017 /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 L300 Go System. The L300 Go builds upon the global success of the company’s NESS L300® Foot Drop System and NESS L300 Plus® System with numerous advancements, including the introduction of 3D motion detection of gait events, multi-channel stimulation and a mobile iOS application to track user activity.

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.

The new myBioness™ mobile iOS application allows home users of the system to track activity, set personal goals and review their progress over time using dynamic reporting capabilities. The app has been designed to keep users engaged in the rehabilitation process and motivated to meet their recovery goals.

Multi-channel stimulation is an additional noteworthy L300 Go feature that allows clinicians to precisely control the amount of dorsiflexion and inversion/eversion the system provides. Using a new, proprietary electrode, medial and lateral stimulation can be adjusted independently. This more efficient fitting process saves valuable time and facilitates more productive therapy sessions.

“The healthcare system is being challenged to objectively document and improve functional capabilities. To help meet these demands, clinicians are turning to technologies that speed up rehabilitation timelines and provide a personalized recovery plan,” said Todd Cushman, President and CEO of Bioness. “Technological innovations including 3D motion detection and multi-channel stimulation work together to improve treatment efficiency and promote patient mobility. At Bioness, we are focused on improving the lives of patients through technology and are proud to add the L300 Go into our growing portfolio of products.”

The L300 Go System was cleared by the U.S. Food and Drug Administration on January 27, 2017.  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 L300 Go in the spring of 2017. Initially, the system will only be available to healthcare professionals for clinic use. Home user availability is targeted for the later part of 2017. Current users of the L300 Foot Drop System and L300 Plus System will be eligible for a Customer Loyalty Upgrade Program which is designed to make the new technology more accessible for users in the clinic and community.

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, undeserved 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.

Source: Bioness Receives FDA Clearance for the L300 Go™ System

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[Press Announcements] FDA allows marketing of first-of-kind computerized cognitive tests to help assess cognitive skills after a head injury.

August 22, 2016

Release

The U.S. Food and Drug Administration today permitted marketing of two new devices to assess a patient’s cognitive function immediately after a suspected brain injury or concussion. The Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) and ImPACT Pediatric are the first medical devices permitted for marketing that are intended to assess cognitive function following a possible concussion. They are intended as part of the medical evaluation that doctors perform to assess signs and symptoms of a head injury.

ImPACT and ImPACT Pediatric are not intended to diagnose concussions or determine appropriate treatments. Instead the devices are meant to test cognitive skills such as word memory, reaction time and word recognition, all of which could be affected by a head injury. The results are compared to an age-matched control database or to a patient’s pre-injury baseline scores, if available.

“These devices provide a useful new tool to aid in the evaluation of patients experiencing possible signs of a concussion, but clinicians should not rely on these tests alone to rule out a concussion or determine whether an injured player should return to a game,” said Carlos Peña, Ph.D., M.S., director of the division of neurological and physical medicine devices at the FDA’s Center for Devices and Radiological Health.

ImPACT software runs on a desktop or laptop and is intended for those ages 12 to 59, while the ImPACT Pediatric runs on an iPad and is designed for children ages 5 to 11. Only licensed health care professionals should perform the test analysis and interpret the results.

Traumatic brain injuries account for more than 2 million emergency room visits in the United States each year, according to the U.S. Centers for Disease Control and Prevention, and contribute to the deaths of more than 50,000 Americans. A significant percentage of these injuries are considered to be mild. A concussion is considered to be a mild traumatic brain injury.

The manufacturer submitted over 250 peer-reviewed articles, of which half were independently conducted clinical research studies. The research publications analyzed the scientific value of the ImPACT devices including the devices’ validity, reliability and ability to detect evidence of cognitive dysfunction that might be associated with a concussive head injury. The FDA concluded that these studies provide valid scientific evidence to support the safety and effectiveness of the ImPACT and ImPACT Pediatric devices.

The FDA reviewed the ImPACT device through its de novo classification process, a regulatory pathway for novel, low- to-moderate-risk medical devices that are first-of-a-kind, for which special controls can be developed, in addition to general controls, to provide a reasonable assurance of safety and effectiveness of the devices. The device is manufactured by ImPACT Applications, located in Pittsburgh, Pennsylvania.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Source: Press Announcements > FDA allows marketing of first-of-kind computerized cognitive tests to help assess cognitive skills after a head injury

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[WEB SITE] FDA approves Vanderbilt-designed Indego exoskeleton for clinical and personal use | Research News @ Vanderbilt | Vanderbilt University

by | Mar. 10, 2016

Segway with legs’ approved by FDA for use by people with paraplegia

The U.S. Food and Drug Administration (FDA) has given clearance to market and sell the powered lower-limb exoskeleton created by a team of Vanderbilt engineers and commercialized by the Parker Hannifin Corporation for both clinical and personal use in the United States.

portrait

Michael Goldfarb (Vanderbilt University)

“I’m really glad,” said H. Fort Flowers Professor of Mechanical Engineering Michael Goldfarb who developed the exoskeleton with a team of engineers and students in his Center for Intelligent Mechatronics. “It is particularly gratifying because it is the first thing that has come out of my lab that has become a product that people can purchase, which hopefully will make a significant improvement in their quality of life.”

Indego®, which allows people paralyzed below the waist to stand up and walk, is the result of an intensive, 10-year effort. The initial development was funded by a grant from the National Institute of Child Health and Human Development. In 2012 Parker, a global leader in motion and control technologies, purchased an exclusive license to market the design and has worked closely with Goldfarb’s group to develop a commercial version of the medical device.

“Parker has done an excellent job in running their leg of the relay race, bringing the exoskeleton to market in just three years,” said Goldfarb.

Until recently “wearable robots” like Indego were the stuff of science fiction. In the last 15 years, however, advances in robotics, microelectronics, battery and electric motor technologies have made it practical to develop them to aid people with stroke and spinal cord injuries. The device acts like an external skeleton. It straps in tightly around the torso. Rigid supports are strapped to the legs and extend from the hip to the knee and from the knee to the foot. The hip and knee joints are driven by computer-controlled electric motors powered by advanced batteries. Patients use the powered apparatus with walkers or forearm crutches to maintain their balance.

“You can think of our exoskeleton as a Segway with legs. If the person wearing it leans forward, he moves forward. If he leans back and holds that position for a few seconds, he sits down. When he is sitting down, if he leans forward and holds that position for a few seconds, then he stands up,” Goldfarb said.

man wearing exoskeleton and using crutches stands next to able-bodied woman

Person wearing an Indego exoskeleton (Courtesy of Parker Hannifin)

Indego is the second exoskeleton to receive FDA certification for U.S. use. The first was a device produced by Rewalk Robotics Ltd. However, Indego’s clearance came after completion of the largest exoskeleton clinical trail conducted in the United States. According to the Parker news release, “Over the course of more than 1,200 individual sessions, study participants were able to use Indego to safely walk on a variety of indoor and outdoor surfaces and settings with no serious adverse events.”

One of Goldfarb’s design goals was to give users the maximum amount of personal freedom possible. One of his requirements, for example, was to allow the user to put the exoskeleton on and take it off while sitting in a wheelchair. As a result, the Indego is considerably lighter and less bulky than the other exoskeletons under development.

Indego also has two features that are specifically designed to aid in rehabilitation:

  • The amount of robotic assistance adjusts automatically for users who have some muscle control in their legs. This allows them to use their own muscles while walking. When a user is totally paralyzed, the device does all the work. The other designs provide full power all of the time.
  • It is the only wearable robot that incorporates a proven rehabilitation technology called functional electrical stimulation. FES applies small electrical pulses to paralyzed muscles, causing them to contract and relax. FES can improve strength in the legs of people with incomplete paraplegia. For complete paraplegics, FES can improve circulation, change bone density and reduce muscle atrophy.

The innovative nature of the Indego design led Popular Mechanics to name Goldfarb one of its “Ten Innovators Who Changed The World” in 2013.

Beginning this summer, Goldfarb will head a four-year U.S. Department of Defense-funded study of the tangible economic and rehabilitation benefits of exoskeletons for people with spinal cord injuries. This will be performed at three medical centers: James Haley Veteran’s Hospital in Tampa (the first VA center in the country to use Indego), the Mayo Clinic in Rochester, Minnesota and the Vanderbilt University Medical Center.

People who use wheelchairs regularly can develop serious problems with their urinary, respiratory, cardiovascular and digestive systems, as well as getting osteoporosis, pressure sores, blood clots and other afflictions associated with lack of mobility. The risk for developing these conditions can be reduced considerably by regularly standing, moving and exercising their lower limbs. The study, which will involve 24 participants, is designed to determine whether regular use of the Indego will also reduce these conditions.

Indego has been available in Europe since November, when it received the CE Mark, the European Union’s equivalent of FDA approval. The initial price is $80,000.

The next step is getting the device approved for health insurance reimbursement. This involves getting the Centers for Medicare and Medicaid Services (CMS) to approve a “rate code” for the exoskeleton: a numeric code that identifies the characteristics of patients who Medicare/Medicaid will reimburse for purchasing a given piece of medical equipment. Typically, the government will reimburse 80 percent of the cost of approved medical devices. In most cases private health insurance providers adopt the CMS code.

Related Stories

Media Inquiries:
David Salisbury, (615) 322-NEWS
david.salisbury@vanderbilt.edu

Source: FDA approves Vanderbilt-designed Indego exoskeleton for clinical and personal use | Research News @ Vanderbilt | Vanderbilt University

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[WEB SITE] Lightweight Robotic Exoskeleton Approved By FDA | Popular Science

POWER WALKING INTO THE FUTURE

The Indego exoskeleton, which was approved by the FDA today

The Indego exoskeleton, which was approved by the FDA today

The Indego robotic exoskeleton has received approval from the FDA. The device, which is 26 pounds and designed to be easy to put on and take off from a wheelchair, was tested in an extensive clinical trial, assessing its safety on a variety of indoor and outdoor surfaces.

“It is particularly gratifying because it is the first thing that has come out of my lab that has become a product that people can purchase, which hopefully will make a significant improvement in their quality of life,” Vanderbilt engineering professor Michael Goldfarb said in a statement.

Indego is strapped tightly around the torso, with rigid supports attaching to the hip, knee, and foot. Battery-powered, computer-controlled electric motors drive the joints, and the wearer navigates the device similar to a Segway, according to the engineers. Lean forward and the exoskeleton walks forward, lean back for a while and it will sit down.

Indego, which has been available in Europe since November, is the second exoskeleton to gain FDA approval in the U.S. The first, ReWalk was approved in 2014. Indego’s selling point is its weight–almost 20 pounds lighter than ReWalk–and its functional electrical stimulation, which sends little electrical pulses to the paralyzed muscles. Those pulses could help lessen muscle atrophy and improve circulation. Now, Parker Hannifin, the manufacturer, needs to show that the device can reduce the secondary medical conditions often caused by lower-body paralysis, in order to convince insurance companies to cover the $80,000 device. According to the Wall Street Journal, the company plans a commercial launch for Indego in the U.S. “in the coming months.”

Source: Lightweight Robotic Exoskeleton Approved By FDA | Popular Science

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[WEB SITE] Magstim’s Repetitive Transcranial Magnetic Stimulation Therapy System FDA Cleared to Fight Major Depression (VIDEO)

Magstim-Rapid2

The FDA awarded Magstim, a Carmarthenshire, Wales firm, clearance to bring to market the company’s Magstim Rapid2 rTMS (repetitive Transcranial Magnetic Stimulation) Therapy System. The system is indicated to treat drug resistant major depressive disorder in an outpatient setting.

The Magstim Rapid2 has been available to researchers in fields such as cognitive neuroscience, neurophysiology, and rehabilitation. Now the magnetic stimulator will be available in the U.S. as a clinical product.

It’s intended to target the dorsolateral left pre-frontal cortex (DLPFC), a region of the brain that sees reduced blood flow in patients with serious depression. When magnetically stimulated, blood flow tends to increase, improving mood and reducing symptoms of the depression.

Here’s Robin Davies, the CEO of Magstim, talking about the Rapid2 rTMS system:

via Magstim’s Repetitive Transcranial Magnetic Stimulation Therapy System FDA Cleared to Fight Major Depression (VIDEO).

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