Presidio Medical获得神经调节平台的IDE批准-动脉网

Presidio Medical granted IDE approval for neuromodulation platform

Medical Device Network 等信源发布 2025-06-13 10:19

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According to the WHO, around 619 million people worldwide are affected by chronic low back pain (LBP). Image credit: Teeradej via Shutterstock.

根据世界卫生组织的数据，全球约有6.19亿人受到慢性腰痛（LBP）的影响。图片来源：Teeradej通过Shutterstock。

Presidio Medical has received an investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA), paving the way towards a pivotal study of its neuromodulation platform for treating chronic nociceptive lower back pain (LBP).

Presidio Medical 已获得美国食品药品监督管理局 (FDA) 的研究性器械豁免 (IDE) 批准，为其神经调节平台治疗慢性伤害性下背痛 (LBP) 的关键研究铺平了道路。

The US-based company’s ultra-low frequency (ULF) neuromodulation platform is designed to provide pain relief for nociceptive LBP by delivering ULF electric currents via spinal cord stimulation (SCS), targeting pain localised to the lower back by inhibiting neuronal pain responses.

这家美国公司的超低频（ULF）神经调节平台旨在通过脊髓刺激（SCS）传递ULF电流，抑制神经元疼痛反应，从而为伤害性下背痛（LBP）提供疼痛缓解。

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Nociceptive pain relates to pain that occurs due to actual damage to the body,

伤害性疼痛是指由于身体实际损伤而引起的疼痛，

with burns, muscle strains, and trauma

伴有烧伤、肌肉拉伤和创伤

all being common causes. Pain in the body is otherwise referred to as neuropathic, whereby the pain originates in the nervous system.

所有这些均为常见原因。身体疼痛通常指神经性疼痛，即疼痛源于神经系统。

With the IDE secured, Presidio said it will now initiate its pivotal, randomised controlled FULFILL trial at sites in the US and Australia.

Presidio表示，在确保IDE安全后，现在将启动其关键的随机对照FULFILL试验，地点设在美国和澳大利亚。

Results from a first-in-human study of Presidio’s ULF platform were presented at this year’s North American Neuromodulation Society (NANS) 2025 meeting, which took place in Florida from 30 January to 1 February.

Presidio的ULF平台的首次人体研究结果在今年的北美神经调节学会（NANS）2025年会议上公布，该会议于1月30日至2月1日在佛罗里达州举行。

Sharing results from the prospective trial (NCT05837234), Dr Mark Russo, director at Hunter Pain Specialists in Australia and key investigator on the trial, stated that

分享来自前瞻性试验（NCT05837234）的结果时，澳大利亚亨特疼痛专科主任、该试验的主要研究者马克·鲁索博士表示，

53% of patients who received the treatment had “80% to 100% of their pain disappear”.

53%的患者在接受治疗后，疼痛“消失了80%到100%”。

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Presidio CEO Michael Onuscheck commented: “The results from our first-in-human clinical trial in Australia were very encouraging. We are excited to now begin a more robust trial, which we believe will demonstrate the safety and efficacy of our ULF platform.”

Presidio首席执行官迈克尔·奥努斯切克评论道：“我们在澳大利亚进行的首次人体临床试验的结果非常令人鼓舞。我们很高兴现在开始一项更为严格的试验，我们相信这将证明我们的ULF平台的安全性和有效性。”

Neuromodulation is a promising frontier in medical technology, with ongoing research and development aimed at enhancing treatment options for various neurological conditions.

神经调节是医疗技术领域一个充满希望的前沿，目前的研究和开发正致力于增强针对各种神经系统疾病的治疗选择。

Other companies working on devices for treating LBT include Irish company Mainstay Medical. In January, the manufacturer shared results from a one-year study of its ReActiv8 Restorative Neurostimulation system. Meeting its primary endpoint of change of mean improvement in the Oswestry Disability Index (ODI) score between treatment and control arms at the one-year follow-up, the system .

其他致力于治疗LBT设备的公司包括爱尔兰的Mainstay Medical。今年一月，该公司分享了其ReActiv8修复性神经刺激系统一年期研究的结果。该系统在一年随访时达到了主要终点，即治疗组和对照组之间Oswestry残疾指数（ODI）评分平均改善的变化。

achieved statistical significance

达到统计学显著性

of ODI -19.7 ± 1.4 for the ReActiv8 arm versus -2.9 ± 1.4 in the control arm.

ReActiv8组的ODI为-19.7 ± 1.4，而对照组为-2.9 ± 1.4。

According to the World Health Organization (WHO), LBP affects around 619 million people worldwide, with a

根据世界卫生组织 (WHO) 的数据，全球约有 6.19 亿人受到 LBP 的影响，

breakdown of the lumbar multifidus muscle (MF)

腰椎多裂肌（MF）的分解

thought to be a key driver of the pathology.

被认为是病理学的关键驱动因素。

The WHO forecasts that LBP will increase to