ST. LOUIS PARK, Minn.--(BUSINESS WIRE)--Enterra Medical, Inc., an innovator in treatments for people living with gastroparesis, announced today that the Enterra® II System has been granted MR Conditional approval from the United States Food and Drug Administration (FDA).

明尼苏达州圣路易斯公园（BUSINESS WIRE）-Enterra Medical，Inc。是胃轻瘫患者治疗的创新者，今天宣布Enterra®II系统已获得美国食品和药物管理局（FDA）的MR有条件批准。

The Enterra II System (specifically its component parts Enterra 37800 Neurostimulator and Enterra Therapy 4351-35 unipolar leads) is an advanced treatment system, designed to relieve the nausea and vomiting symptoms associated with gastroparesis—a complex medical condition that prevents the stomach from emptying properly..

Enterra II系统（特别是其组件部件Enterra 37800神经刺激器和Enterra Therapy 4351-35单极引线）是一种先进的治疗系统，旨在缓解与胃轻瘫相关的恶心和呕吐症状-一种复杂的医疗状况，可防止胃排空正常。。

The MR Conditional label means that patients who receive or have received the Enterra II System in the past can safely undergo Magnetic Resonance Imaging (MRI) examinations of the head or upper/lower extremity under certain conditions.

MR条件标签意味着过去接受或已经接受Enterra II系统的患者可以在某些条件下安全地进行头部或上/下肢的磁共振成像（MRI）检查。

“This is a significant milestone in our journey to increase innovation in this therapeutic area and to help people living with gastroparesis find relief,” said Peter Sommerness, Chief Executive Officer of Enterra Medical.

Enterra Medical首席执行官Peter Sommerness说：“这是我们在这一治疗领域增加创新并帮助胃轻瘫患者缓解的旅程中的一个重要里程碑。

“For people living with gastroparesis who have considered Enterra Therapy in the past, the ability to have MRI scans may have been an important factor in their decision,” said Kenneth Koch, MD, Vice President and Medical Director of Enterra Medical. “We are hopeful that the ability to perform MRI examinations will bring patients one step closer to relief from their nausea and vomiting symptoms with Enterra Therapy.

“对于过去曾考虑过Enterra治疗的胃轻瘫患者，MRI扫描的能力可能是他们决定的重要因素，”Enterra Medical副总裁兼医疗总监Kenneth Koch博士说。“我们希望进行MRI检查的能力能够使患者通过Enterra疗法更接近缓解恶心和呕吐症状。

We remain passionately focused on helping all gastroparesis patients take back their seat at the table.”.

我们仍然热衷于帮助所有胃轻瘫患者重新坐在桌子上。”。

About Enterra® Therapy

关于Enterra®疗法

Enterra Therapy was originally developed by Medtronic and approved by the FDA as a Humanitarian Device in 2000. A unique therapy called Gastric Electrical Stimulation (GES), Enterra Therapy delivers mild electrical pulses to the nerves and smooth muscles of the stomach to control the chronic nausea and vomiting symptoms associated with gastroparesis.

Enterra疗法最初由美敦力公司开发，并于2000年被FDA批准为人道主义设备。一种称为胃电刺激（GES）的独特疗法，Enterra疗法向胃的神经和平滑肌提供温和的电脉冲，以控制与胃轻瘫相关的慢性恶心和呕吐症状。

To learn more about Enterra Therapy visit the company’s website and follow us on LinkedIn..

要了解更多关于Enterra疗法的信息，请访问公司的网站并在LinkedIn上关注我们。。

About Enterra Medical

关于Enterra Medical

Enterra Medical was founded in 2022 to help people living with chronic nausea and vomiting find the relief to take back their seat at the table. For help navigating diagnosis and considering the treatment options that are right for you, visit www.enterramedical.com.

Enterra Medical成立于2022年，旨在帮助患有慢性恶心和呕吐的人找到缓解措施，使他们重新坐在桌子上。有关导航诊断和考虑适合您的治疗方案的帮助，请访问www.enterramedical.com。

Important Safety Information

重要的安全信息

Intended Use: The Enterra® Therapy System is an implanted device that provides gastric stimulation to treat chronic, intractable, nausea and vomiting that is not well treated by drugs or other means in patients aged 18 to 70 years caused by diabetes or an unknown origin.

预期用途：Enterra®治疗系统是一种植入装置，可提供胃刺激，以治疗慢性，难治性，恶心和呕吐，这些药物或其他手段无法很好地治疗由糖尿病或不明原因引起的18至70岁患者。

Contraindications: Enterra Therapy is only for patients who are healthy enough for surgical procedures and/or anesthesia. Once implanted, patients need to avoid diathermy, which is deep heat treatment from electromagnetic energy, as it may cause injury or device failure.

禁忌症：Enterra疗法仅适用于足够健康的外科手术和/或麻醉患者。一旦植入，患者需要避免透热疗法，这是电磁能量的深度热处理，因为它可能导致伤害或设备故障。

Warnings: Enterra Therapy has not been studied in pregnant women, patients under the age of 18, or over 70. Issues may occur if the system interacts with other implanted devices such as pacemakers. Patient injury or device failure may be caused by other medical treatments such as electrocautery, defibrillation/cardioversion, therapeutic ultrasound, or radiofrequency (RF)/microwave ablation.

警告：Enterra疗法尚未在孕妇，18岁以下或70岁以上的患者中进行研究。如果系统与起搏器等其他植入设备交互，可能会出现问题。患者受伤或设备故障可能由其他医学治疗引起，例如电烙术，除颤/心脏复律，治疗性超声或射频（RF）/微波消融。

Patient activities may cause shocking or jolting sensations..

患者的活动可能会引起令人震惊或震动的感觉。。

The Enterra II System is MR Conditional. This means that patients with the Enterra II System can safely have MRI examinations of some body parts under certain conditions. Consult your doctor to determine if you are eligible for MRI examination.

Enterra II系统是MR有条件的。这意味着Enterra II系统的患者可以在某些条件下安全地对某些身体部位进行MRI检查。咨询您的医生以确定您是否有资格进行MRI检查。

Risks: Potential risks include infection, pain at the surgery site, allergic or immune system response, lead and bowel twist together, device wearing through the skin, bruising, bleeding, loss of therapeutic effect, jolting, shocking, burning sensation, gastrointestinal or stomach issues, loss of therapy due to component failure or battery wear out, or perforated stomach which may cause life-threatening blockage or infections that require immediate medical attention including surgery.

风险：潜在风险包括感染，手术部位疼痛，过敏或免疫系统反应，铅和肠扭曲，穿过皮肤的设备，瘀伤，出血，治疗效果丧失，震动，烧灼感，胃肠道或胃部问题，由于组件故障或电池磨损导致的治疗损失，或胃穿孔，可能导致危及生命的阻塞或感染，需要立即就医，包括手术。

Risks can be minimized by avoiding activities such as sudden, excessive, or repetitive bending, twisting, bouncing, or stretching..

通过避免突然，过度或重复弯曲，扭曲，弹跳或拉伸等活动，可以将风险降至最低。。

Humanitarian Device: Authorized by Federal law for the intended use described above. The effectiveness of this device has not been demonstrated.

人道主义装置：经联邦法律授权用于上述预期用途。该设备的有效性尚未得到证实。

Always discuss potential risks and benefits of the device with your physician.

始终与您的医生讨论该设备的潜在风险和益处。

For further information, please contact Enterra Medical at info@enterramedical.com.

欲了解更多信息，请联系Enterra Medicalinfo@enterramedical.com.

Rx Only.

仅限Rx。

Enterra® is a registered trademark of Enterra Medical, Inc. in the US, EU, and other regions.

Enterra®是Enterra Medical，Inc.在美国，欧盟和其他地区的注册商标。

This press release contains “forward-looking statements” concerning the development of Enterra Medical’s products, the benefits and attributes of such products, and the company’s expectations regarding its prospects. Forward-looking statements are subject to risks, assumptions and uncertainties that could cause actual future events or results to differ materially from such statements.

本新闻稿包含有关Enterra Medical产品开发，此类产品的益处和属性以及公司对其前景的期望的“前瞻性声明”。前瞻性陈述可能会导致实际未来事件或结果与此类陈述有重大差异的风险，假设和不确定性。

These statements are made as of the date of this press release. Actual results may vary. Enterra Medical undertakes no obligation to update any forward-looking statements for any reason..

这些声明自本新闻稿发布之日起生效。实际结果可能会有所不同。Enterra Medical不承担因任何原因更新任何前瞻性陈述的义务。。