SynerFuse™与Velentium医疗合作，扩大脊柱融合与神经直接刺激手术的整合规模-动脉网

SynerFuse™ & Velentium Medical Partnering to Scale Integrated Spinal Fusion & Direct Nerve Stimulation Procedure

CISION 等信源发布 2025-03-21 21:05

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New Velentium Medical Facility Providing Neuromodulation Device Design & Manufacture

新Velentium医疗设施提供神经调节设备设计与制造

EDEN PRAIRIE, Minn.

明尼苏达州伊甸草原

，

March 21, 2025

2025年3月21日

/PRNewswire/ -- To follow up on the completion of its clinical proof-of-concept study, SynerFuse™ and its partner, Velentium Medical, today announced plans to scale the patented SynerFuse™ e-TLIF™ procedure implant device.

/PRNewswire/ -- 为跟进其临床概念验证研究的完成，SynerFuse™及其合作伙伴Velentium Medical今天宣布了扩大其获得专利的SynerFuse™ e-TLIF™ 手术植入装置规模的计划。

'With the completion of our proof-of-concept study, we advanced our mission to improve patient quality of life,' said Zenanko. 'The SynerFuse™ proof-of-concept study demonstrated the safety and feasibility of integrating direct nerve stimulation with open lumbar or lumbosacral decompression and instrumented fusion.

“随着我们概念验证研究的完成，我们推进了改善患者生活质量的使命，”Zenanko表示。“SynerFuse™概念验证研究展示了将直接神经刺激与开放式腰椎或腰骶减压及器械融合相结合的安全性和可行性。”

And now we move on to the next phase in our quest to bring our therapy to the many patients who could benefit from it.'.

现在，我们进入到下一个阶段，继续努力将我们的疗法带给那些可能受益的众多患者。

'The SynerFuse™ e-TLIF™ technique will be a new treatment approach of integrating neuromodulation with spinal decompression and fusion for the 500,000-plus patients who undergo traditional spinal fusion surgery in

“SynerFuse™ e-TLIF™ 技术将是一种新的治疗方法，结合神经调节、脊柱减压和融合技术，应用于每年接受传统脊柱融合手术的50多万患者。

the United States

美国

each year,' said Velentium Medical Chairman & Cofounder Dan Purvis. 'We are excited about the potential of this therapy and about moving forward with SynerFuse™.'

Velentium Medical董事长兼联合创始人丹·普尔维斯表示：“我们对这种疗法的潜力感到兴奋，并期待与SynerFuse™一同前进。”

'We are pleased to have been selected by SynerFuse™ as their strategic development and manufacturing partner, showcasing our industry-leading design, development, and manufacturing capabilities for both devices and leads. From our new flagship facility in

“我们很高兴被SynerFuse™选为他们的战略开发和制造合作伙伴，展示了我们在设备和导线方面的行业领先设计、开发和制造能力。从我们新的旗舰工厂开始，

Houston, Texas

德克萨斯州休斯顿市

, our experienced team will Change Lives for a Better World as we scale production for SynerFuse™,' said Velentium Medical Cofounder Tim Carroll.

“我们经验丰富的团队将改变生活，创造更美好的世界，因为我们正在扩大SynerFuse™的生产规模，”Velentium Medical联合创始人蒂姆·卡罗尔表示。

'Our custom-designed device was conceived by our medical team—that is, by surgeons for surgeons addressing neuropathic and mechanical pain,' said

“我们的定制设备由我们的医疗团队构思设计，也就是说，由外科医生为外科医生设计，旨在解决神经性疼痛和机械性疼痛，”

Rohan Lall

罗汉·拉尔

, M.D., SynerFuse™ chief medical officer and former investigator at MHealth Fairview. 'With the SynerFuse™ DRG system (implantable pulse generator and custom leads) designed and manufactured by Velentium Medical, the SynerFuse™ e-TLIF™ procedure incorporates insights from our 15-patient proof-of-concept clinical trial that was completed with our collaborators at the .

，医学博士，SynerFuse™首席医疗官，曾任MHealth Fairview研究员。 “通过Velentium Medical设计和制造的SynerFuse™ DRG系统（植入式脉冲发生器和定制导线），SynerFuse™ e-TLIF™手术融合了我们与合作者共同完成的15名患者的概念验证临床试验的见解。

University of Minnesota

明尼苏达大学

and South Bend Orthopaedics.'

南本德骨科。'

'Requiring only a single incision and involving direct visual placement of the neurostimulation device will make the SynerFuse™ e-TLIF™ procedure better in terms of patient safety,' said

“只需一个切口并涉及神经刺激装置的直接可视放置，将使SynerFuse™ e-TLIF™手术在患者安全性方面更具优势，”

University of Minnesota

明尼苏达大学

Associate Professor of Neurosurgery Michael C. Park, M.D., Ph.D.*, SynerFuse™ proof-of-concept study principal investigator. 'Our data indicate that we should maintain the therapy we used in the proof-of-concept trial.'

神经外科副教授迈克尔·C·帕克医学博士、哲学博士*，SynerFuse™概念验证研究首席研究员。“我们的数据表明我们应该继续沿用在概念验证试验中使用的疗法。”

'The SynerFuse™ e-TLIF™ therapy represents a novel integration of next-generation stimulation and monitoring with spinal decompression and instrumented fusion. Our initial experience has found this to aid in post-operative treatment of back and leg pain,' said

“SynerFuse™ e-TLIF™ 疗法代表了下一代刺激和监测与脊柱减压和器械融合的全新整合。我们的初步经验发现这有助于术后治疗背痛和腿痛，”他说。

Deepak Reddy

迪帕克·雷迪

, M.D., South Bend Orthopaedics and SynerFuse™ proof-of-concept study principal investigator. 'The therapy unlocks an additional safe modality to treat surgical, neuropathic and mechanical back and leg pain whilst reducing the patients' exposure to opioids.'

，医学博士，南本德骨科和SynerFuse™概念验证研究的首席研究员。“这种疗法提供了一种额外的安全治疗方式，用于治疗手术后、神经性和机械性背痛及腿痛，同时减少了患者接触阿片类药物的机会。”

More information about SynerFuse™ is available at

有关 SynerFuse™ 的更多信息，请访问

www.synerfuse.com

. More information about Velentium Medical is available at

更多关于Velentium Medical的信息，请访问

http://www.velentiummedical.com/

。

About Chronic Lower Back Pain (cLBP)

关于慢性下腰痛（cLBP）

cLBP is defined as lower back pain that continues for 12 weeks or longer, even after an initial injury or underlying cause of acute lower back pain has been treated.

慢性下背痛被定义为持续12周或更长时间的下背痛，即使在急性下背痛的初始损伤或潜在原因已经得到治疗后仍然存在。

With more than 500,000 procedures performed annually, spinal fusion remains a common treatment for spinal instability, albeit with a high incidence of residual neuropathic pain.

每年进行超过50万例手术，脊柱融合术仍然是治疗脊柱不稳的常用方法，尽管残留神经性疼痛的发生率较高。

Up to 40% of patients who undergo spinal fusion end up with Failed Back Surgery Syndrome (FBSS), a condition resulting in significant, lingering neuropathic pain, costing the U.S. healthcare system

多达40%的脊柱融合术患者最终患上背部手术失败综合征（FBSS），这种疾病会导致显著的、持续的神经性疼痛，给美国医疗系统带来巨大成本。

$20B

200亿美元

per year and significantly affecting the quality of life of patients.

每年显著影响患者的生活质量。

About SynerFuse™

关于SynerFuse™

SynerFuse™ is a

SynerFuse™ 是一个

Delaware

特拉华州

corporation based in Minnesota—the heart of Medical Alley

总部位于明尼苏达州——医疗中心的心脏地带

and the cradle of neuromodulation and medical device innovation

神经调控和医疗器械创新的摇篮

. SynerFuse™ believes that individuals with cLBP/FBSS and their providers deserve an alternative option than spinal fusion alone. Even when spinal fusion is successful, it can often result in residual chronic neuropathic pain and use of addictive opioids. The company is working to create a non-narcotic pain management for chronic low back pain with a patented therapy that integrates spinal fusion hardware and an active neuromodulation system.

SynerFuse™认为，患有cLBP/FBSS的个体及其医疗服务提供者应该拥有比单纯脊柱融合术更好的替代选择。即使脊柱融合手术成功，也常常会导致残留的慢性神经性疼痛以及成瘾性阿片类药物的使用。该公司正致力于通过一种结合脊柱融合硬件和主动神经调节系统的专利疗法，为慢性下背痛患者提供一种非麻醉药物的疼痛管理方案。

More information about the company is available at .

更多关于公司的信息可以在以下网址获取：。

www.synerfuse.com

。

This communication contains information about an investigational product. This product is limited by Federal (U.S.) law to investigational use only. SynerFuse™ makes no claims regarding the safety or effectiveness of the unapproved investigational product. The intent of providing this information is to convey research and development initiatives underway at SynerFuse™..

本通讯包含有关一种研究性产品信息。根据联邦（美国）法律，该产品仅限于研究使用。SynerFuse™ 并未对未经批准的研究性产品的安全性和有效性做出任何声明。提供此信息的目的是传达 SynerFuse™ 正在进行的研发计划。

SynerFuse™ Milestones

SynerFuse™ 里程碑

July 2018

2018年7月

: SynerFuse™ founded

：SynerFuse™ 成立

July 2019

2019年7月

: FDA approves feasibility study

：FDA批准可行性研究

December 2019

2019年12月

：

University of Minnesota

明尼苏达大学

Institutional Review Board approves feasibility study

机构审查委员会批准可行性研究

March 2020

2020年3月

: Clinical trial agreement finalized with

：临床试验协议已与

University of Minnesota

明尼苏达大学

Medical School

医学院

January 2022

2022年1月

: First patient implanted—Dr.

：首位患者植入——博士

Michael C. Park

迈克尔·C·帕克

implanted stimulator and leads, Dr.

植入刺激器和导线，博士。

Rohan Lall

罗翰·拉尔

implanted fusion

植入融合

January 2023

2023年1月

: South Bend Orthopaedics activated as second clinical site

南本德骨科作为第二个临床站点启用

June 2023

2023年6月

: First solo procedure performed by former investigator Dr.

：前调查员博士首次单独进行的程序

Rohan Lall

罗翰·拉尔

(implanted fusion with stimulator and leads)

（植入式融合刺激器及导线）

August 2023

2023年8月

: Second solo procedure performed by principal investigator Dr.

：由首席研究员博士执行的第二次单独程序

Deepak Reddy

深卡·雷迪

, showing solo surgeon can learn and implement procedure outside

，显示单独的外科医生可以学习并在外部实施手术过程

University of Minnesota

明尼苏达大学

October 2023

2023年10月

: 15th patient implanted

：第15位患者已植入

October 2024

2024年10月

: Final 12-month patient follow-up completed

：完成最后12个月的患者随访

*Dr. Park holds stock options from SynerFuse.

*朴博士持有SynerFuse的股票期权。

About Velentium Medical

关于Velentium医疗

Velentium Medical is a

Velentium Medical 是一家

Richmond, Texas

德克萨斯州里士满

-based professional engineering firm that exists to transform IP into the design and manufacture of safe and secure medical devices that will change lives and create a better world. More information about the company is available at

一家基于专业的工程公司，致力于将知识产权转化为安全可靠的医疗设备的设计与制造，这些设备将改变生活，创造更美好的世界。更多关于该公司的信息可访问

www.velentiummedical.com

。

See

看见

'Low Back Pain Fact Sheet.' National Institute of Neurological Disorders and Stroke,

“腰痛概况。” 国立神经疾病和中风研究所，

https://www.ninds.nih.gov/sites/default/files/migrate-documents/low_back_pain_20-ns-5161_march_2020_508c.pdf

, accessed

，访问

3 March 2025

2025年3月3日

。

Karen L. Saban

凯伦·L·萨班

et al., 'Health-Related Quality 3 Marchof Life of Patients Following Selected Types of Lumbar Spinal Surgery: A Pilot Study,' Health and Quality of Life Outcomes 5 (2007),

等人，《选择性腰椎手术后患者健康相关生活质量的初步研究》，《健康与生活质量结果》5卷（2007年），

https://doi.org/10.1186/1477-7525-5-71

, accessed

，访问

17 October 2023

2023年10月17日

。

Farber SH, Han JL, Elsamadicy AA, Hussaini Q, Yang S, Pagadala P, Parente B, Xie J, Lad SP. Long-term Cost Utility of Spinal Cord Stimulation in Patients with Failed Back Surgery Syndrome. Pain Physician. 2017 Sep;20(6):E797-E805. PMID: 28934786; PMCID: PMC8358894.

法伯 SH，韩 JL，埃尔萨马迪西 AA，侯赛尼 Q，杨 S，帕加达拉 P，帕伦特 B，谢 J，拉德 SP。脊髓刺激在背手术综合征失败患者中的长期成本效用分析。《疼痛医师》。2017年9月；20(6):E797-E805。PMID: 28934786；PMCID: PMC8358894。

SOURCE SynerFuse

来源：SynerFuse

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