Axonics® Submits Full Body MRI Data to U.S. Food & Drug Administration for its Sacral Neuromodulation System

Axonics®向美国食品和药物管理局提交其骶神经调节系统的全身 MRI 数据

2019-02-12 23:40:04 BioSpace

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IRVINE, Calif.---- Axonics Modulation Technologies, Inc. a medical technology company focused on the development and commercialization of novel implantable Sacral Neuromodulation devices for the treatment of urinary and bowel dysfunction, today announced the submission of complete test data to the U.S. Food & Drug Administration for the purpose of gaining Conditional Full Body Magnetic Resonance Imaging labeling approval for the Axonics r-SNM® System1 for urinary and bowel dysfunction. This data was submitted as an amendment to the Company’s previously filed premarket approval application . Raymond W. Cohen, CEO of Axonics, commented, “Without this Full Body labeling, any patient requiring an MRI scan on any body part below the head must have their neurostimulator and lead surgically explanted prior to the MRI scan, resulting in loss of an effective treatment, another surgery for the patient and additional cost to the patient and healthcare system. Our robust testing and analyses conclude that Full Body MRI scans can be safely performed on patients with an implanted Axonics r-SNM system.” The Axonics r-SNM System is already approved for head and neck MR scans in Europe, Canada and Australia. CE Mark approval of Full Body MRI conditional labeling for the Axonics r-SNM System is currently pending. Cohen continued, “We met with the FDA in January 2019 and determined it was advantageous to file an amendment to the current literature-based PMA. The FDA now has all of our MRI test data for both head and full body and we believe that, once PMA approved, our r-SNM System will include conditional labeling for 1.5T MRI scans.” Axonics has performed all the required tests to support Full Body conditional labeling on 1.5T MR scanners for the implantable components of its r-SNM System. What is MRI Conditional Labeling MRI is short for Magnetic Resonance Imaging. MR scanners come in different magnet field strengths measured in Tesla or “T”, usually between 0.5T and 3.0T. They also come in varying sizes including open and wide-bore. Simplistically, an MR scanner is a very large, strong magnet into which a patient lies. A radio wave is used to send signals to the body of the patient. The returning signals are received and converted into images by a computer attached to the MR scanner. The image quality of an MRI depends on signal and field strength. MRI Conditional Labeling means a product has been tested and demonstrated to pose no known hazards to the patient in a specified MRI environment with specified conditions of use and the results of testing are sufficient to characterize the behavior of the product in the MRI environment. Testing for devices that may be placed in the MRI environment should address magnetically induced displacement force and torque, unintended stimulation, and thermal injury. Other possible safety issues include but are not limited to, image artifact, device vibration, interaction among devices, the safe functioning of the device and the safe operation of the MRI system. Any parameter that affects the safety of the device should be listed and any condition that is known to produce an unsafe consequence must be described. About Overactive Bladder and Sacral Neuromodulation Overactive bladder (OAB) includes urinary urge incontinence and urinary frequency and affects an estimated 85 million adults in the U.S. and Europe. OAB is caused by a miscommunication between the bladder and the brain and significantly impacts quality of life. SNM therapy is a well-established treatment that has been widely employed to reduce symptoms and restore bladder function and is also a proven therapy to treat urinary retention and fecal incontinence. Reimbursement for SNM is well established and available in the United States, Europe, Canada and Australia. About Axonics Modulation Technologies, Inc. Axonics, based in Irvine, CA, is focused on development and commercialization of a novel implantable SNM system for patients with urinary and bowel dysfunction. The Axonics r-SNM System is the first rechargeable Sacral Neuromodulation system approved for sale in Europe, Canada and Australia. The r-SNM System offers a temporary disposable external trial system, a miniaturized and rechargeable long-lived stimulator that is qualified to function for at least 15 years. Also included is a tined lead, as well as patient-friendly accessories such as a charging system optimized for minimal charge time without overheating, a small, easy to use patient remote control and an intuitive clinician programmer that facilitates lead placement and programming. For more information, visit the Company’s website at www.axonicsmodulation.com. Forward-Looking Statements Statements made in this press release that relate to future plans, events, prospects or performance are forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995. Words such as “planned,” “expects,” “believes,” “anticipates,” “designed,” and similar words are intended to identify forward-looking statements. While these forward-looking statements are based on the current expectations and beliefs of management, such forward-looking statements are subject to a number of risks, uncertainties, assumptions and other factors that could cause actual results to differ materially from the expectations expressed in this press release, including the risks and uncertainties disclosed in Axonics filings with the Securities and Exchange Commission, all of which are available online at www.sec.gov. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, Axonics undertakes no obligation to update or revise any forward-looking statements to reflect new information, changed circumstances or unanticipated events. 1 The Axonics r-SNM® System is an investigational medical device View source version on businesswire.com: https://www.businesswire.com/news/home/20190212005287/en/ Axonics’ Contact Axonics Modulation Technologies, Inc. Dan Dearen, +1-949-396-6320 President & Chief Financial Officer ir@axonics.com Investor & Media Contact W2Opure Matt Clawson, +1-949-370-8500 mclawson@w2ogroup.com Source: Axonics Modulation Technologies, Inc. View this news release online at: http://www.businesswire.com/news/home/20190212005287/en
加州 IRVINE 。--- Axonics Modulation Technologies , Inc .是一家专注于新型植入性骶神经调节装置的研发和商业化的医疗技术公司,用于治疗泌尿系统和肠道功能障碍。今天宣布向美国食品和药物管理局提交完整的试验数据,以获得轴心-SNM ®系统1用于泌尿和肠功能障碍的条件全身体磁共振成像标记批准。该数据作为公司先前提交的上市前批准申请的修订提交。 Axonics 首席执行官 RaymondW.Cohen 评论道:“没有这个完整的身体标记,任何需要头部以下任何身体部位的 MRI 扫描的患者必须在 MRI 扫描之前进行神经刺激并进行外科移植,导致丧失有效的治疗方法。另一种是针对病人的手术,以及病人和医疗保健系统的额外费用。我们的强大测试和分析得出结论,全身体 MRI 扫描可以安全地对植入轴心磁共振成像系统的患者进行。” Axonics r-SNM 系统已经在欧洲、加拿大和澳大利亚被批准用于头颈部磁共振扫描。目前正在等待 CE 标志批准的全身体 MRI 条件标签的轴心-SNM 系统。 Cohen 接着说,“我们在2019年1月与 FDA 会面,确定对当前基于文献的上市前批准(PMA)进行修订是有利的。FDA 现在已经为头部和全身提供了所有的 MRI 测试数据,我们相信,一旦上市前批准(PMA)获得批准,我们的 r-SNM 系统将包含1.5T MRI 扫描的条件标签。” 轴心系统已经进行了所有必要的测试,以支持1.5T 磁共振扫描仪上的全身条件标签的 R-SNM 系统的植入性组成部分。 什么是 MRI 条件标签 核磁共振成像是磁共振成像的简称.磁共振扫描仪的磁场强度不同,测量特斯拉或“ T ”,通常在0.5T 至3.0T 之间。它们也有不同的尺寸,包括开孔和宽孔。简单地说,磁共振扫描仪是一个非常大,强大的磁铁,病人躺在其中。无线电波被用来向病人的身体发送信号。返回信号由附加到 MR 扫描仪的计算机接收并转换成图像。MRI 的图像质量取决于信号和磁场强度.MRI 条件标签是指在特定的 MRI 环境中,产品已被测试并证明不会对患者造成已知危害,且测试结果足以描述产品在 MRI 环境中的行为。可能放置在 MRI 环境中的设备的测试应解决磁致位移和扭矩、意外刺激和热损伤。其他可能的安全问题包括但不限于图像伪影、设备振动、设备之间的相互作用、设备的安全运行和 MRI 系统的安全运行。应列出影响设备安全的任何参数,并且必须描述已知会产生不安全后果的任何条件。 过度活跃的膀胱和骶神经调节 膀胱过度活跃( OAB )包括尿急失禁和尿频,在美国和欧洲估计有8500万成年人受到影响。OAB 是由于膀胱和大脑之间的沟通失误而引起的,并对生活质量产生显著影响。SNM 治疗是一种成熟的治疗方法,广泛应用于减轻症状和恢复膀胱功能,也是治疗尿潴留和大便失禁的有效方法。SNM 的报销在美国、欧洲、加拿大和澳大利亚都很完善。 关于 Axonics 模块化技术公司。 Axonics 公司位于加州 Irvine ,致力于开发和商业化一种新型的可植入 SNM 系统,用于治疗尿路和肠道功能障碍。Axonics r-SNM 系统是首个获准在欧洲、加拿大和澳大利亚销售的可充电骶神经调节系统。r-SNM 系统提供了一个临时的一次性外部试验系统,这是一个微型和可充电的长寿命刺激器,有资格运行至少15年。此外还包括一种带刺的铅,以及病人友好的配件,例如在没有过热的情况下最小充电时间最优化的充电系统,一个小的,易于使用的病人远程控制和一个直观的临床医生程序员,促进铅置和编程。欲了解更多信息,请访问公司网站 www.axonicsmoolation.com 。 前瞻性陈述 本新闻稿中所作与未来计划、事件、前景或业绩有关的陈述是1995年《私人证券诉讼改革法案》中定义的前瞻性陈述。“有计划的”、“预期的”、“相信的”、“预期的”、“设计的”和类似的词旨在识别前瞻性陈述。虽然这些前瞻性陈述基于管理层目前的预期和信念,但该等前瞻性陈述受若干风险、不确定性、假设及其他因素影响,可能导致实际结果与本新闻稿所表达的预期存在重大差异。包括 Axonics 提交给美国证券交易委员会的文件中披露的风险和不确定性,所有这些都可在 www.sec.gov 网站上查阅。读者应注意不要过度依赖这些前瞻性陈述,这些陈述仅在本协议签订之日起生效。除法律要求外, Axonics 不承担更新或修改任何前瞻性陈述的义务,以反映新信息、变化的情况或意外事件。 1 Axonics r-SNM ®系统是一种研究医疗设备 查看 businesswire 上的源代码。http://www.businesswire.com/news/home/20190212587/en/ 轴心接触 轴心调制技术公司。 Dan Dearen ,+1-949-396-6320 总裁兼首席财务官 ir @ axonics.com 投资者和媒体联系人 W2Opure MattClawson ,+1-949-370-8500 mclawson @ w2ogroup.com 来源:轴心调制技术公司。 在线查看本新闻稿,网址为: http://www.businesswire.com/news/home/20190212587/en