读医学网

美国食品药品管理局（FDA）正式批准ReWalk 个人使用系统上市，第一次让那些因脊髓损伤致下半身瘫痪的患者能够在自己家中使用可穿戴式动力外骨骼。

这种机器人装置是由一个为患者定制的金属支架组成，穿戴在下肢以及上半身的部分位置，由远程无线设备来操控。适用于身高介于160 -190 厘米，体重不超过220磅（≈100公斤）的患者。

ReWalk 个人使用系统由马达驱动，可以帮助髋关节、膝关节和踝关节运动。配套的电脑和电源装在背包里。患者使用拐杖行走，通过戴在手腕上的无线远程控制器来操控设备。

生产商Argo MedicalTechnologies公司发言人称，ReWalk售价69,500美元，目前医保不能报销，不过正在与保险公司协调中。公司还声称，使用该设备带来的潜在医疗效益包括减少住院治疗和部分药物治疗，这能抵消一部分成本。

在美国，ReWalk 个人使用系统并不是唯一的动力外骨骼系统，但是到目前为止，康复机构和退伍军人事务部（VA）医院大多使用的都是ReWalk以及类似（还有有些不同）的外骨骼系统，比如Ekso Bionics。

FDA医疗器械和放射健康中心医疗器械评价办公室主任Christy Foreman在一份书面声明中表示：“像ReWalk这样的创新设备能够大大帮助脊髓损伤患者重新获得一定程度的行动能力。通过物理治疗、训练以及看护者的帮助，患者能够借助这些设备重新在其家中和社区里行走。”

FDA称，因T7（第7胸椎）- L5（第5腰椎）节段脊髓损伤致截瘫的患者可以在经过专门培训的看护者的帮助下使用该设备。T4（第4胸椎）-T6（第6胸椎）节段脊髓损伤的患者也可以使用该设备，但是只能在康复机构内使用。该设备不能用于开展运动或者爬楼梯。

患者及其看护者（可以是患者的配偶或者家庭健康助理）必须在康复中心或者某家VA医院成功完成ReWalk培训计划。医生在开具该设备的处方之前会根据培训情况评估患者的技术水平。

但是，FDA要求在接受ReWalk使用培训之前：

? 患者能够通过辅助站立装置（比如站立架）站立，患者的手臂和肩膀能够支撑拐杖或手杖。

? 如果患者有除脊髓损伤以外的其他重度神经系统损伤病史，或者存在重度痉挛、明显挛缩、脊柱不稳定、肢体骨折未愈或骨盆骨折，则不能使用该设备。

? 如果患者存在重度合并症，比如感染、循环障碍、心脏病、肺病或褥疮，也不能使用该设备。

生产商称，ReWalk个人使用系统由马达驱动，可以帮助髋关节、膝关节和踝关节运动，在经过培训的看护者的帮助下让患者能够站立、坐下、转身和行走。该设备有一个动作感应器，配套的电脑和电源装在背包里。患者使用拐杖行走，通过戴在手腕上的无线远程控制器来操控设备。该设备重46磅（≈21公斤），但使用者基本上只会感受到背包的重量，背包重量约为5磅（≈2公斤）。

作为ReWalk的发明者，以色列人Amit Goffer博士在公司新闻发布会上说：“是人在操控设备行走，而不是设备在操控人行走。”“一切都由使用者来操控，当他们想坐下时，就可以操控设备坐下，当他们想站起来行走时，就可以操控设备这样做。” Goffer博士本人在1997年的一次ATV事故后变成了四肢截瘫。

ReWalk 设备已经在欧洲、以色列和其他一些国家上市使用。ReWalk的康复机构使用版本于2011年在全球上市，个人使用版本于2012年开始销售。

尚不清楚另一个品牌的外骨骼系统何时能获得FDA的上市批准。Ekso Bionics公司发言人表示：“我们很高兴FDA打开了这扇门，我们很期待市场的反应。”发言人指出，目前公司主要关注康复市场，但有的患者是在物理治疗师的帮助下在家中使用该设备，公司开展的临床研究也在进行这方面的尝试。

ReWalk 个人使用系统是通过FDA的新型分类程序进行审批的，该审批程序主要针对中低风险的新型首创医疗器械。FDA在审核了该设备的耐用性、硬件、软件和电池系统，并且评审了来自一项30例受试者研究和一项16例受试者观察性研究的临床数据之后，正式批准该设备上市销售。

生产商报告称：“ReWalk系统的研究数据表明该设备还可能改善患者的心血管健康，减少脂肪组织，增加肌肉量，并且改善肠道功能。来自ReWalk使用者的反馈也证实了这些潜在效益和其他效益，比如更好的疼痛管理，用药减少，住院治疗可能也会减少。”

FDA要求生产商完成上市后临床研究以收集与该设备相关的不良事件数据并且评估培训计划是否足够充分。

FDA clears marketingof robotic exoskeleton for at-home use

By: NASEEM MILLER,Internal Medicine News Digital Network

June 27, 2014

The Food and DrugAdministration has cleared the marketing of the ReWalk Personal System, therebyfor the first time enabling individuals with lower-body paralysis because of aspinal cord injury to use a wearable motorized exoskeleton at home.

The robotic deviceconsists of a fitted, metal brace worn over the legs and part of the upper bodyand is controlled by a wireless remote. It accommodates individuals withheights from 5’3 to 6’3 and weighs up to 220 pounds.

ReWalk costs $69,500and is currently not covered by insurance, although company officials are intalks with insurance companies, according to a spokesperson. The company alsosays that the potential medical benefits of using the device will offset thecost by reducing hospitalization and some medications.

ReWalk PersonalSystem is not the only motorized exoskeleton available in the United States,but so far, ReWalk, along with similar (but different) exoskeleton systems suchas Ekso Bionics, have been mainly used in rehabilitation facilities andVeterans Affairs hospitals.

Innovativedevices such as ReWalk go a long way towards helping individuals with spinalcord injuries gain some mobility, Christy Foreman, director of the Officeof Device Evaluation at the FDA’s Center for Devices and Radiological Health,said in a written statement. Along with physical therapy, training, andassistance from a caregiver, these individuals may be able to use these devicesto walk again in their homes and in their communities.

Individuals withparaplegia due to spinal cord injuries at level T7 (seventh thoracic vertebra)to L5 (fifth lumbar vertebra), can use the device when accompanied by aspecially trained caregiver, according to the FDA.

People with spinalcord injury at levels T4 (fourth thoracic vertebra) to T6 (sixth thoracicvertebra) can also use the device, but only in rehab facilities, according tothe FDA. The device is not for sports or climbing stairs.

Consumers and theircaregivers, who could be a spouse or home health aid, must successfullycomplete a training program designed by ReWalk at a rehabilitation center or aVA hospital. Physicians evaluate the individual’s skill level based on trainingbefore writing a prescription for the device.

But, according to theFDA, prior to being trained to use ReWalk:

? Patients should be ableto stand using an assistive standing device (e.g., standing frame), and theirhands and shoulders should be able to support crutches or a walker.

? Patients should not usethe device if they have a history of severe neurologic injuries other thanspinal cord injury, or have severe spasticity, significant contractures,unstable spine, unhealed limb fractures, or pelvic fractures.

? Patients should alsonot use the device if they have severe concurrent medical diseases such asinfection, circulatory conditions, heart or lung conditions, or pressure sores.

The ReWalk PersonalSystem consists of motors that help with movement of hips, knees, and ankles,enabling people to sit, stand, turn and walk, with assistance from a trainedperson. The device has a tilt sensor, and its computer and power supply arecontained in a backpack. Patients use crutches, and they control the devicewith a wireless remote control worn on the wrist. The device weighs 46 pounds,but the user feels mostly the weight of the backpack, which is about 5 pounds,according to the company.

The personwalks the system, the system does not walk them, Dr. Amit Goffer, theIsraeli inventor of ReWalk who became quadriplegic after an ATV accident in1997, said in a company news release. The users are in control – whenthey want to sit, they sit, when then want to stand and walk, they do so.

The device,manufactured by Argo Medical Technologies, has been in use in Europe, Israel,and other countries. The rehab version of ReWalk became availableinternationally in 2011, while sales of the personal system began in 2012.

It is not clear whenanother brand of exoskeletons will be cleared for marketing by the FDA. We’re excited that the FDA has opened this gateway and look forward toseeing how the market reacts, said a spokesperson for Ekso Bionics,noting that the company is currently focused on the rehabilitation market, butsome individuals use the device at home with a physical therapist and inclinical studies conducted by the company.

The ReWalk personalsystem was reviewed through FDA’s de novo classification process, used fornovel, first-of-its-kind medical devices that are low to moderate risk. Theagency cleared the device after reviewing its durability, hardware, software,and battery system, in addition to assessing clinical data from a 30-subjectstudy and a 16-patient observational study.

The company reportsthat Study data of the ReWalk system indicate potential improvements incardiovascular health, loss of fat tissue, building of lean muscle mass, andimproved bowel function. Feedback from ReWalk users supports these potentialbenefits and others, such as better pain management, fewer medications, and potentiallyreduced hospitalizations.

The device’smanufacturer is required to complete a postmarket clinical study to collectdata on adverse events related to device use and to assess the adequacy of itstraining program, according to the FDA.