Levita Magnetics, a company in the forefront of surgical innovation, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the use of its Magnetic Surgical System (MSS), combined with the MARS® system's, in bariatric and hiatal hernia repair procedures. This expanded indication reinforces Levita's ability to support surgeons treating patients with obesity-related conditions, offering a less invasive solution that enables simultaneous treatment of hiatal hernias during bariatric surgery..

Levita Magnetics 是一家处于外科创新前沿的公司，今天宣布美国食品药品监督管理局 (FDA) 已批准其磁外科系统 (MSS) 与 MARS® 系统结合使用于减重手术和食管裂孔疝修复程序的 510(k) 许可。这一扩展适应症进一步巩固了 Levita 支持治疗肥胖相关疾病患者的能力，提供了一种微创解决方案，可以在减重手术中同时治疗食管裂孔疝。

The FDA clearance enables clinicians to use the MARS system's Dynamic Magnetic Positioning™ technology to retract the liver and enhance visibility and access during hiatal hernia repairs. This approval offers an innovative, less invasive option for abdominal surgery and paves the way for broader adoption of the technology across hospitals and ambulatory surgical centers nationwide.

美国食品药品监督管理局（FDA）的批准使临床医生能够使用MARS系统的动态磁定位™技术来牵开肝脏，从而在食管裂孔疝修复过程中提高可见性和操作空间。这项批准为腹部手术提供了一种创新且创伤更小的选择，并为该技术在全国范围内的医院和门诊手术中心的广泛应用铺平了道路。

The clearance also marks the release of Levita's new 12.5mm magnetic grasper, specifically engineered to improve visualization and control in patients with high BMI and large or difficult-to-retract livers. The device allows surgeons to grasp the liver more centrally, rather than from the edge, improving surgical access in both hernia and bariatric procedures..

该审批通过还标志着 Levita 推出新的 12.5 毫米磁力抓取器，专门设计用于改善高体重指数和大或难以牵拉的肝脏患者的可视化和控制。该设备允许外科医生更靠近中心抓取肝脏，而不是从边缘抓取，从而改进了在疝气和减肥手术中的手术通路。

'This expanded clearance is a major step forward. With the improved grasper and magnetic liver retraction, I can now perform complex bariatric procedures and hiatal hernia repairs with greater visibility and fewer incisions,' said Dr. Chad Carlton, a Dallas-based surgeon and long-time MARS user. 'It's a smarter, less invasive way to care for patients—especially those with high BMI and challenging anatomy, with less pain.'.

“这一扩展的清除范围是一个重大的进步。通过改进的抓取器和磁性肝脏牵拉，我现在可以更清晰地视野下进行复杂的减重手术和食管裂孔疝修复，并且减少了切口数量，”达拉斯的外科医生、长期使用MARS系统的查德·卡尔顿博士说道，“这是一种更智能、更微创的患者护理方式——特别是对于高BMI和解剖结构复杂的患者，还能减轻疼痛。”

Unlike other robotic systems that often rely on rigid instrumentation and multiple incisions, the MARS platform introduces a new paradigm: using proprietary magnetic technology to reposition organs internally. This innovation allows surgeons to reduce the number of incisions, minimize tissue trauma, and enhance patient recovery, all while maintaining surgical precision and control..

与其他通常依赖刚性仪器和多处切口的机器人系统不同，MARS平台引入了一种新的模式：利用专有的磁性技术在体内重新定位器官。这一创新使外科医生能够减少切口数量、减轻组织损伤并促进患者康复，同时保持手术的精确性和控制力。

'This milestone reinforces our commitment to expanding access to better surgery,' said Dr. Alberto Rodriguez-Navarro, founder and CEO of Levita Magnetics. 'We're building a future where less invasive means more effective.'

“这一里程碑强化了我们对手术扩展获取更好手术的承诺，”Levita Magnetics 创始人兼首席执行官阿尔贝托·罗德里格斯-纳瓦罗博士说。“我们正在构建一个未来，微创意味着更有效。”

Commercial Momentum and Market Opportunity

商业动力和市场机会

Hiatal hernia repair is a common procedure, frequently performed alongside bariatric surgery in patients with obesity-related conditions. Levita's newly cleared indication allows the MARS system to better support this high-need patient population, offering improved access and visualization through magnetic retraction and an updated toolset..

食管裂孔疝修补术是一种常见手术，经常在肥胖相关疾病的患者中与减重手术同时进行。Levita新获批的适应症允许MARS系统更好地支持这一高需求患者群体，通过磁力牵引和升级的工具包提供更好的入路和可视化效果。

With the addition of this indication and the new 12.5mm grasper, Levita is expanding its addressable market and strengthening its commercial offerings for surgical teams managing complex abdominal cases.

随着这一适应症的增加和新的12.5毫米抓取器的推出，Levita正在扩大其可覆盖的市场，并加强针对处理复杂腹部病例的外科团队的商业产品。

Pioneering the Future of Magnetically Assisted Surgeries

开创磁辅助手术的未来

Levita's continued innovation has opened new frontiers in surgical care. From enabling groundbreaking bariatric procedures to supporting surgeries designed to improve quality of life, the company's MARS platform is redefining what's possible in the operating room. With a growing body of clinical use cases and national media attention highlighting patient outcomes—from dramatic weight loss to minimally invasive cancer-related procedures, Levita is helping surgeons deliver transformative results across a wide spectrum of care..

Levita的持续创新开辟了外科护理的新领域。从实现突破性的减重手术到支持旨在改善生活质量的手术，该公司的MARS平台正在重新定义手术室中可能实现的目标。随着越来越多的临床应用案例和全国媒体对患者疗效的关注——从显著的体重减轻到微创的癌症相关手术，Levita正在帮助外科医生在广泛的护理范围内提供变革性的成果。

Levita also continues to expand its clinical presence nationwide and internationally and expects to install systems at multiple top-tier institutions in the short term.

Levita还在继续扩大其在全国和国际上的临床应用，并预计短期内将在多个顶级机构安装该系统。

For media inquiries or to request an interview with Dr. Carlton or Dr. Rodriguez-Navarro, please contact:

媒体咨询或要求采访卡尔顿博士或罗德里格斯-纳瓦罗博士，请联系：

Tim Gray

蒂姆·格雷

Communications Strategist

通信策略师

917-202-9515

917-202-9515

[email protected]

[email protected]

About Levita Magnetics

关于Levita Magnetics

Levita Magnetics is a Silicon Valley-based medical device company pioneering --minimally invasive platforms that use magnetics to improve surgical precision while reducing invasiveness. Its flagship MARS system provides surgeons with enhanced control and visualization while minimizing the trauma of traditional surgery.

Levita Magnetics是一家位于硅谷的医疗设备公司，开创了使用磁力来提高手术精度同时减少侵入性的微创平台。其旗舰产品MARS系统为外科医生提供了增强的控制和可视化能力，同时最大限度地减少了传统手术带来的创伤。

The MARS platform is FDA-approved for gallbladder, bariatric, prostate, colorectal, and now hiatal hernia procedures..

MARS平台已获FDA批准用于胆囊、减肥、前列腺、结直肠手术，现在还可用于食管裂孔疝手术。

Source: prnewswire.com

来源：prnewswire.com