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美国食品药品监督管理局清除Levita Magnetics的MARS系统

FDA Clears Levita Magnetics' MARS System

mpo-mag 等信源发布 2023-10-25 10:54

可切换为仅中文


Levita Magnetics has received U.S. Food and Drug Administration (FDA) clearance for its MARS platform.

Levita Magnetics已获得美国食品和药物管理局(FDA)对其MARS平台的许可。

The Levita MARS system is a first-of-its-kind minimally invasive surgical platform aimed at the high-volume abdominal surgery market. Harnessing the power of both magnets and machines, MARS reduces the number of incisions and enables surgeons to have complete control during laparoscopic procedures, all in a compact footprint designed to fit into existing operating rooms. .

Levita MARS系统是针对大容量腹部手术市场的首创微创手术平台。MARS利用磁铁和机器的力量,减少了切口的数量,使外科医生能够在腹腔镜手术过程中完全控制,所有这些都是紧凑的占地面积,适合现有的手术室。。.

Building on the success of its first commercial product, the Levita Magnetic Surgical System, Levita designed MARS to deliver the same patient benefits as Magnetic Surgery, while empowering surgeons with increased control of surgical instruments and providing an efficient way for hospitals and ambulatory surgery centers (ASCs) to incorporate this new technology. .

Levita Magnetic Surgical System在其第一个商业产品Levita Magnetic Surgical System的成功基础上,设计了MARS,以提供与磁性手术相同的患者益处,同时增强外科医生对手术器械的控制,并为医院和门诊手术中心提供有效的方法(ASC)整合这项新技术。。.

'This marks a significant milestone in Levita's mission to provide more patients access to state-of-the-art surgical technology. MARS is poised to revolutionize surgical options for a broad range of patients,” Levita Magnetics Founder/CEO Dr. Alberto Rodriguez-Navarro, a surgeon, said. “With this FDA clearance, we eagerly anticipate making a substantial impact across the value chain.' .

“这标志着莱维塔为更多患者提供最先进的手术技术的使命中的一个重要里程碑。外科医生Levita Magnetics创始人/首席执行官Alberto Rodriguez-Navarro博士说,MARS有望彻底改变广泛患者的手术选择。“通过FDA的批准,我们热切期待在整个价值链中产生重大影响。”。.

MARS aims to deliver triple impact:

MARS旨在实现三重影响:

Patients experience less-invasive surgery with reduced incisions, resulting in less pain, faster recovery, and fewer scars.

患者经历侵入性较小的手术,切口减少,导致疼痛减轻,恢复更快,疤痕更少。

Surgeons benefit from a surgical system giving them full control over both the laparoscopic view—reducing the need for an additional assistant—as well as over the Magnetic Surgical System, enabling retraction of large tissues and organs such as the liver, gallbladder, prostate, and colon.

外科医生受益于手术系统,使他们完全控制腹腔镜视图,减少了对额外助手以及磁性手术系统的需求,从而能够收回大组织和器官,如肝脏,胆囊,前列腺和结肠。

Hospitals and ASCs can benefit from increased efficiency, more effective deployment of OR personnel, and the ability to offer a differentiated patient experience.

医院和ASC可以从提高效率,更有效地部署OR人员以及提供差异化患者体验的能力中受益。

“MARS by Levita has the potential to reshape the surgical industry and forever change medical innovation. Our MARS platform gives patients and surgeons a transformative tool that will usher in a fundamental shift in surgery for years to come,” Levita Magnetics Chairperson Maria Sainz stated. “Levita’s system can aid in surgeon proficiency and efficiency, and can reduce the need for assistive personnel, signaling a major achievement not only for Levita but for surgical care.” .

Levita Magnetics主席Maria Sainz说:“Levita的MARS有可能重塑外科行业并永远改变医疗创新。我们的MARS平台为患者和外科医生提供了一个变革性的工具,将在未来几年开启手术的根本转变。”。“Levita的系统可以帮助外科医生的熟练程度和效率,并可以减少对辅助人员的需求,不仅为Levita而且为外科护理带来重大成就。”。.

Headquartered in Silicon Valley, Levita Magnetics' proprietary technology is designed to advance minimally invasive surgery. Levita developed the Levita Magnetic Surgical System and MARS; proprietary technologies designed to minimize the footprint of surgery and improve patient outcomes.  .

Levita Magnetics总部设在山谷,其专有技术旨在推进微创手术。Levita开发了Levita磁性手术系统和MARS;专有技术旨在最大限度地减少手术足迹并改善患者预后。  .