Boston Scientific is hopping on the bandwagon as the latest developer of a spinal cord stimulation system to receive FDA approval for diabetic neuropathy pain relief.

波士顿科学公司（Boston Scientific）作为脊髓刺激系统的最新开发人员，正在紧随潮流，以获得FDA批准用于缓解糖尿病神经病变疼痛。

The newly handed-down regulatory nod went to the devicemaker’s WaveWriter Alpha spinal cord stimulators, which were initially approved in both the U.S. and Europe in late 2020 with an indication to help relieve chronic pain in the trunk and limbs.

新发布的监管许可授予了devicemaker的WaveWriter Alpha脊髓刺激器，该刺激器最初于2020年末在美国和欧洲获得批准，用于缓解躯干和四肢的慢性疼痛。

The FDA’s expanded indication now allows the implants to target diabetic neuropathy in the lower extremities, in which high blood sugar levels in people with diabetes injure their nerves in the legs and feet, causing feelings of pain and numbness. According to data cited by Boston Scientific, around half of all U.S.

FDA的扩大适应症现在允许植入物针对下肢的糖尿病神经病变，糖尿病患者的高血糖水平会损伤他们的腿和脚的神经，导致疼痛和麻木感。根据波士顿科学引用的数据，大约一半的美国。

adults living with diabetes—who currently number in the tens of millions—will experience painful diabetic neuropathy at some point..

目前有数千万糖尿病患者的成年人在某些时候会经历痛苦的糖尿病神经病变。。

“The use of SCS to support a subset of the diabetes population is an important advancement for one of the fastest growing chronic conditions in the world,″ Jim Cassidy, president of Boston Scientific’s neuromodulation division, said in a company announcement Wednesday. ″This expanded indication is another testament to our commitment to delivering a robust portfolio of interventional pain solutions that provides physicians with more treatment choices to help their patients find relief.”.

波士顿科学公司神经调节部门总裁吉姆·卡西迪（JimCassidy）周三在一份公司公告中表示：“使用干细胞支持糖尿病人群的一部分，对于世界上增长最快的慢性病之一来说，这是一项重要的进步。”这一扩大的适应症再次证明了我们致力于提供强大的介入性疼痛组合为医生提供更多治疗选择以帮助患者缓解的解决方案。”。

Like other spinal cord stimulation systems, the WaveWriter Alpha technology centers around a small pulse generator that’s implanted near the spinal cord. It sends out mild electrical pulses through an attached lead to reach targeted nerves on the spinal cord, with an aim of interrupting the pain signals traveling between those nerves and the brain..

像其他脊髓刺激系统一样，WaveWriter Alpha技术以植入脊髓附近的小型脉冲发生器为中心。它通过连接的导线发出轻微的电脉冲，到达脊髓上的目标神经，目的是中断这些神经和大脑之间传递的疼痛信号。。

The WaveWriter Alpha portfolio comprises four separate systems featuring various combinations of the number of contact points embedded on the stimulator and both rechargeable and non-rechargeable options. All of the devices can safely stay implanted during MRI scans, and all are Bluetooth-enabled, allowing patients and doctors to adjust their therapy regimens as needed using a wireless remote..

WaveWriter Alpha产品组合包括四个独立的系统，其特点是刺激器上嵌入的触点数量以及可充电和不可充电选项的各种组合。所有设备都可以在MRI扫描期间安全地植入，并且都支持蓝牙，允许患者和医生使用无线遥控器根据需要调整治疗方案。。

The launch of the WaveWriter Alpha devices also saw Boston Scientific unveil its Fast-Acting Sub-perception Therapy, or FAST—which, as the name suggests, enables the implants to begin providing pain relief within just a few minutes of their initial programming.

WaveWriter Alpha设备的推出也见证了波士顿科学公司（Boston Scientific）推出了其速效亚感知疗法（Fast），顾名思义，Fast可以使植入物在最初编程的几分钟内开始缓解疼痛。

Several other devicemakers have added diabetic neuropathy indications to their own spinal cord stimulators in recent years, with Abbott’s Proclaim XR hardware earning that expanded FDA approval earlier this year and Medtronic tacking it onto its Intellis and Vanta neuromodulation systems in early 2022..

近年来，其他几家设备制造商已将糖尿病神经病变适应症添加到自己的脊髓刺激器中，雅培（Abbott）宣布XR硬件今年早些时候获得了FDA的批准，美敦力（Medtronic）于2022年初将其应用于Intellis和Vanta神经调节系统。。

The first of this string of approvals went to Nevro in mid-2021. Since then, the company has racked up plenty of data proving its Senza system’s success in treating painful diabetic neuropathy: Two-year study results published this summer showed that 142 people implanted with the rechargeable device had experienced an average pain reduction of nearly 80%, and almost 90% of the participants saw their pain levels cut at least in half after two years of use..

这一系列批准中的第一批于2021年年中授予了Nevro。从那时起，该公司收集了大量数据，证明其Senza系统在治疗痛苦的糖尿病神经病变方面取得了成功：今年夏天公布的两年研究结果显示，142名植入可充电设备的人的平均疼痛减轻了近80%，近90%的参与者在使用两年后的疼痛程度至少减轻了一半。。