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NAMSR News: FDA Allows First Medical Device That Allows Paraplegics to Walk

FDA allows marketing of first wearable, motorized device that helps people with certain spinal cord injuries to walk.

 
PRLog - Jul. 10, 2014 - ARLINGTON, Va. -- The U.S. Food and Drug Administration today allowed marketing of the first motorized device intended to act as an exoskeleton for people with lower body paralysis (paraplegia) due to a spinal cord injury. ReWalk is a motorized device worn over the legs and part of the upper body that helps an individual sit, stand, and walk with assistance from a trained companion, such as a spouse or home health aide.

ReWalk has been used in rehabilitation hospitals in the United States for several years and available publicly in Israel, the United Kingdom, and several other European countries. Now it’s available for personal use in the United States, after a recent approval from the Food and Drug Administration.

This means that any disabled person will be able to purchase one, as an alternative to a wheelchair. Several other companies are working on similar devices, but ReWalk is the first to get general FDA approval, and Herrera plans to be the first American to purchase one.

The entire ReWalk rig weighs about 44 pounds. This includes the motorized leg braces, and a backpack that contains a control computer and a couple of lithium-ion batteries to provide up to four hours of mobility.

ReWalk consists of a fitted metal brace that supports the legs and part of the upper body; motors that supply movement at the hips, knees, and ankles; a tilt sensor; and a backpack that contains the computer and power supply. Crutches provide the user with additional stability when walking, standing, and rising from a chair. Using a wireless remote control worn on the wrist, the user commands the ReWalk to stand up, sit down, or walk.

To assess safety and effectiveness of ReWalk, the FDA reviewed testing done to assess ReWalk’s durability, its hardware, software and battery systems, and other safety systems that help minimize risk of injury should the device lose balance or power.

The FDA also reviewed clinical data based on 30 study participants. The clinical tests assessed the participants’ ability to walk various distances, the amount of time needed to walk various distances, performance on various walking surfaces and slight slopes, and performance walking in areas where jostling might occur. Studies also assessed the risk of certain physical effects on the user. Additionally, observational data from 16 patients were also provided to support use of the device on various walking surfaces in the home and community with various levels of assistance from a trained companion. Risks associated with ReWalk include pressure sores, bruising or abrasions, falls and associated injuries, and diastolic hypertension during use.

CANDIDATES WHO WANT TO BREAK INTO MEDICAL SALES:

RMSR® Medical Sales Certification offered by the National Association of Medical Sales Representatives is designed for entry level medical device sales reps. The course covers a wide array of topics pertaining to industry knowledge that candidates need to acquire before applying to medical sales positions.

The course and training helps to develop the industry skills, maximizing the candidates’ potential and goals, as well as making them feel valued and stimulated in their role when communicating with members of the medical community. By an applicant acquiring medical sales training and a RMSR Certification, it puts him/her in a position of strength and qualifies them for medical sales jobs. Medical knowledge is key in this industry and when communicating with doctors, surgeons, and nurses etc. It is extremely important for representatives to use key terminology pertaining to the medical product he/she will be promoting. The only way to succeed in this industry is to garner actual sales. Doctors and Surgeons will not acknowledge a Sales Rep who is not proficient in essential medical terminology, knowledgeable of medical devices/equipment and the anatomy. For those lacking a solid sales background the RMSR course covers knowledge of medical selling techniques and regulation such as Effective Territory Management, Effective Networking, Medical Sales Ethical & Regulatory Guidelines and more.

The National Association of Medical Sales Representative™ (NAMSR) is the largest professional association in the world for Medical Sales Representatives. Through our numerous members, the NAMSR™ provides accredited training, continuing education, information about the industry, up-to-date news, programs to assist medical sales reps in their work, training programs to assist candidates who want to break into the industry and initiatives to improve communication with the medical sales field.

For more information on the NAMSR or the RMSR certification visit www.medicalsalescareer.com or call 800-313-9198


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Source:NAMSR
City/Town:Arlington - Virginia - United States
Industry:Education, Medical
Tags:namsr, rmsr, medical devices, certification, Education
Shortcut:prlog.org/12346827
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