Xınix Medical获得美国食品药品监督管理局SOLACE批准™ NANOACTIV骶髂内固定系统™纳米技术-动脉网

Xēnix Medical Receives FDA Clearance of SOLACE™ Sacroiliac Fixation System with NANOACTIV™ Nanotechnology

BioSpace 等信源发布 2023-11-01 05:19

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First Clearance for a 3D Printed Sacroiliac Fixation System with Nanotechnology and StealthStation® Navigation

具有纳米技术和StealthStation®导航的3D打印骶髂固定系统的首次间隙

ORLANDO, Fla.--(BUSINESS WIRE)-- Xēnix Medical, a surgical implant company focused on the development of novel science-based solutions for patients requiring spinal fusion surgery, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the SOLACE™️ Sacroiliac Fixation System with proprietary NANOACTIV™️ surface technology and compatibility with StealthStation® Navigation..

佛罗里达州奥兰多市（BUSINESS WIRE）-外科植入公司XēnixMedical专注于为需要脊柱融合手术的患者开发基于科学的新型解决方案，今天宣布已获得510（k）美国食品和药物管理局（FDA）批准销售SOLACE™️ 具有专有NANOACTIV的骶髂关节固定系统™️ 表面技术和与StealthStation®导航的兼容性。。

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20231031697414/en/

本新闻稿具有多媒体功能。在这里查看完整版本：https://www.businesswire.com/news/home/20231031697414/en/

Xenix Medical SOLACE Sacroiliac Fixation System (Photo: Business Wire)

Xenix Medical SOLACE骶髂关节固定系统（照片：商业电线）

The SOLACE Sacroiliac Fixation System consists of 3D printed, threaded implants ranging 10.5mm or 12.0mm in diameter and 30mm to 115mm in length. Implants feature Xēnix Medical’s NANOACTIV nanotechnology surface and incorporate helical autograft harvesting flutes and porous channels for boney ingrowth running the length of the device..

SOLACE骶髂关节固定系统由3D打印的螺纹植入物组成，直径为10.5mm或12.0mm，长度为30mm至115mm。植入物具有XēnixMedical的NANOACTIV纳米技术表面，并结合螺旋自体移植物收获槽和多孔通道，用于在装置长度上进行骨向内生长。。

The SOLACE Sacroiliac Fixation System is intended for sacroiliac fusion for sacroiliac joint dysfunction including degenerative sacroiliitis and sacroiliac joint disruptions; augmenting, immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion; and for fracture fixation of acute, non-acute, and non-traumatic fractures involving the sacroiliac joint..

SOLACE骶髂关节固定系统用于骶髂关节融合治疗骶髂关节功能障碍，包括退行性骶髂关节炎和骶髂关节破坏；作为腰椎或胸腰椎融合术的一部分，在进行骶骨固定的骨骼成熟患者中增强，固定和稳定骶髂关节；以及涉及骶髂关节的急性，非急性和非创伤性骨折的骨折固定。。

The system is also cleared for navigation of the SOLACE implants and instrumentation utilizing the Medtronic® StealthStation® system and NavLock® trackers to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures.

该系统还可以使用Medtronic®StealthStation®系统和NavLock®跟踪器导航SOLACE植入物和仪器，以帮助外科医生在开放或微创手术中精确定位解剖结构。

Todd Abel, MD, Neurosurgeon at University of Tennessee Medical Center in Knoxville, Tennessee said, “I am extremely excited about the implant nano surface features and ease of use of the Solace SI System. I believe my patients will have improved fusion rates and improved patient outcomes and quality of life from the NANOACTIV surface.”.

田纳西州诺克斯维尔田纳西大学医学中心神经外科医生Todd Abel博士说：“我对种植体纳米表面特征和Solace SI系统的易用性非常兴奋。我相信我的患者将提高融合率并从NANOACTIV表面改善患者预后和生活质量“。

The NANOACTIV micro and nano-roughened surface is designed to improve fixation to adjacent bone and has been engineered with nano-scale surface features at a nanometer (10-9) level, which have demonstrated the ability to elicit an endogenous cellular and biochemical response as represented by differentiation of human mesenchymal stem cells through the osteogenic lineage and production of a mineralized matrix in vitro1, as compared to an untreated surface2.

NANOACTIV微米和纳米粗糙表面旨在改善对相邻骨骼的固定，并采用纳米（10-9）水平的纳米级表面特征，与未处理的表面相比，已经证明能够引发内源性细胞和生物化学反应，如通过成骨谱系分化人间充质干细胞和在体外产生矿化基质1所代表的。

The NANOACTIV implant surface demonstrates elements to be considered a nanotechnology as outlined in FDA nanotechnology guidance document..

NANOACTIV植入物表面展示了FDA纳米技术指导文件中概述的被认为是纳米技术的元素。。

“The SOLACE Sacroiliac Fixation System is a major first step in the evolution of Xenix Medical beyond an interbody company,” stated Ryan Phillips, President of Xēnix Medical, “Leveraging our expertise in additive manufacturing, this system opens the door to a new level of opportunity for the company to grow within our current and future distribution channels.

“太阳骶髂关节固定系统是Xenix Medical超越体间公司发展的重要的第一步，”XēnixMedical总裁Ryan Phillips说，“利用我们在增材制造方面的专业知识，该系统为新一级打开了大门。公司有机会在我们当前和未来的分销渠道内发展。

The SOLACE system is the only nanotechnology sacroiliac fixation system on the market designed specifically for a lateral, oblique or posterior sacral alar iliac technique, giving surgeons complete versatility with a best-in-class technology platform. This system will also provide independent distributors a superior option to compete with the industry leader in this space, which predominantly utilizes a direct sales force.”.

SOLACE系统是市场上唯一专门为侧骶，斜或后骶髂技术设计的纳米技术骶髂关节固定系统，为外科医生提供完整的多功能性和一流的技术平台。该系统还将为独立分销商提供优越的选择，以与该领域的行业领导者竞争，该领域主要利用直接销售力量“。

1In vitro performance may not be representative of clinical performance

1体外表现可能无法代表临床表现

2Data on file

2存档数据

About Xēnix Medical

关于Xēnix医疗

Xēnix Medical is a surgical implant company focused on the development of novel solutions to advance the science of fusion engineering to enhance the treatment of various pathologies for patients requiring spinal fusion surgery. The company, headquartered in Orlando, Florida, is in active development of multiple unique implant technology platforms and markets its line of spinal implant devices in the United States through a network of independent distributors.

XēnixMedical是一家外科植入公司，专注于开发新的解决方案，以推进融合工程科学，以加强对需要脊柱融合手术的患者的各种病理治疗。该公司总部设在佛罗里达州奥兰多，通过独立分销商网络积极开发多种独特的种植技术平台，并在美国销售其脊柱种植设备系列。

To learn more, visit xenixmedical.com.

要了解更多信息，请访问xenixmedical.com。

Distribution Inquiries: team@xenixmedical.com

分销查询：team@xenixmedical.com

View source version on businesswire.com: https://www.businesswire.com/news/home/20231031697414/en/

在businesswire.com上查看源版本：https://www.businesswire.com/news/home/20231031697414/en/

Contacts

联络

Company Contact

公司联系

Ryan Phillips, President