Medtronic bids for FDA approval of OAB/FI neuromodulation device

美美敦力OAB / FI神经调节设备向FDA提交上市申请

2019-10-08 13:36:52 mass


Medtronic  said today that it filed a pre-market approval supplement with the FDA for its InterStim Micro neurostimulator and its InterStim SureScan MRI leads. The InterStim Micro is a rechargeable, implantable sacral neuromodulation device designed to send electrical impulses to sacral nerves and normalize connections between the brain, bladder and bowel for treating patients with overactive bladders, urinary urge incontinence, unobstructed urinary retention and fecal incontinence. Medtronic said it plans to use SureScan MRI leads in the InterStim Micro system, as well as in future implants of the recharge-free InterStim II system. The leads are designed to produce full-body 1.5- and 3-Tesla MRI conditioning labeling. They are still pending FDA approval. The company believes it is on track to achieve FDA approval for the InterStim Micro and SureScan MRI leads in the spring of 2020. “The FDA submission for InterStim Micro and SureScan MRI leads is a significant milestone for Medtronic and a leap forward in our 20-year history of leadership in sacral neuromodulation,” Medtronic vice president & general manager of pelvic health & gastric therapies Brooke Story said in a news release. “Our ultimate goal is to provide safe and effective treatments to patients affected by bladder and bowel dysfunction, and ensure they have a choice in selecting the most appropriate therapy for their unique situation.” Last month, Axonics Modulation Technologies (NSDQ:AXNX) won FDA approval for its own rechargeable sacral neuromodulation device designed to treat urinary and bowel dysfunction in adults with a neurostimulator the size of a USB drive that lasts 15 years in the body. The company has also filed for pre-market approval to get its device indicated for overactive bladder and urinary retention. Shares of MDT were down -0.8% at $107.69 per share in early-morning trading today.
美美敦力(Medtronic)公司今天表示,它向 FDA 提交了一份上市前批准的补充文件,用于其 InterStim Micro 神经刺激器及其 InterStim SuresScan MRI 的领先优势。 InterStim Micro 是一种可充电、可植入的骶神经调节装置,旨在向骶神经发送电脉冲,并使大脑、膀胱和肠道之间的连接正常化,用于治疗膀胱过度活动症、尿急失禁、尿潴留和大便失禁患者。 美美敦力(Medtronic)公司表示,计划在 InterStim Micro 系统中使用 SuresScan MRI 技术,并在未来植入无充电的 InterStim II 系统。这些引线被设计成生产全体1.5-3-Tesla MRI 调理标记。他们还在等待 FDA 的批准。 该公司认为,有望在2020年春季获得 FDA 批准的 InterStim Micro 和 SurScan MRI 领先产品。 “ FDA 提交给 InterStim Micro 和 SuresScan MRI 的研究报告是美敦力公司的一个重要里程碑,也是我们20年来在骶神经调节领域的领导地位的一个飞跃,”美敦力(Medtronic)公司盆腔健康和胃疗法副总裁兼总经理 Brooke Story 在新闻稿中说。“我们的最终目标是为受膀胱和肠道功能障碍影响的患者提供安全有效的治疗,并确保他们在选择最合适的治疗方案时有一个选择。” 上个月, Axonics Modulation Technologies ( NSDQ : AXNX )获得了 FDA 的批准,该公司推出了自己的可充电骶神经调节设备,用于治疗成人的尿路和肠道功能障碍,该设备的大小相当于 USB 驱动器的大小,在人体内可持续15年。该公司还申请了上市前的批准,以获得其设备表明过度活跃的膀胱和尿潴留。 今日早盘, MDT 股价下跌0.8%,至每股107.69美元。