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胃肠装置系统开发商GT Metabolic™扩展了MagDI™系统,50mm磁铁获得FDA许可

GT Metabolic™ expands MagDI™ System with FDA clearance of 50mm magnet

CISION 等信源发布 2025-03-13 14:34

可切换为仅中文


/PRNewswire/ -- GT Metabolic™ Solutions, Inc., the world leader in magnetic surgery is pleased to announce that the U.S. Food and Drug Administration (FDA) has cleared a larger, 50mm MagDI™ System magnet

/PRNewswire/ -- GT Metabolic™ Solutions, Inc.,磁性手术领域的世界领导者,欣然宣布美国食品药品监督管理局 (FDA) 已批准了更大的 50mm MagDI™ 系统磁铁。

to complement the system's existing 40mm magnet.

以补充系统现有的40毫米磁铁。

This expansion enables surgeons to accommodate a broader range of patients in magnet-assisted surgery for duodenal-ileal anastomosis. The clearance also underscores GT Metabolic's commitment to driving innovative surgical solutions for improved patient outcomes.

这一扩展使外科医生能够在磁辅助十二指肠-回肠吻合术中适应更广泛的患者群体。该许可还强调了GT代谢公司致力于推动创新手术解决方案以改善患者预后的承诺。

The FDA has cleared a larger, 50mm MagDI™ System magnet to complement the system’s existing 40mm magnet.

美国食品药品监督管理局(FDA)已经批准了一款更大的50毫米MagDI™系统磁铁,以补充该系统现有的40毫米磁铁。

The MagDI System is a self-aligning, incisionless, sutureless, and staple-free technology designed to facilitate anastomosis while leaving behind no foreign material.1-5

MagDI系统是一种自对准、无切口、无缝合、无钉的技术,旨在促进吻合的同时不留下任何异物。1-5

With the new choice of the 50mm or 40mm magnet size, the MagDI System offers surgeons greater flexibility to tailor procedures to individual patient needs.

通过选择50毫米或40毫米磁体尺寸,MagDI系统为外科医生提供了更大的灵活性,可以根据患者个体需求定制手术方案。

The only FDA-cleared and commercially available product for magnetic compression anastomosis,

唯一获得FDA批准并商业可用的磁压吻合产品,

the MagDI System is a self-aligning, incisionless, sutureless, and staple-free technology designed to facilitate anastomosis while leaving behind no foreign material.

MagDI系统是一种自对准、无切口、无缝合、无钉的技术,旨在促进吻合,同时不留下任何异物。

'I'm pleased with my early experience using the MagDI System,' said

“我对使用MagDI系统的早期体验感到满意,”

Phil Gachassin

菲尔·加查因

, MD, MHCM, Medical Director of Metabolic and Bariatric Surgery at Ochsner Lafayette General Medical Center. 'The results have been promising, and I'm especially impressed with how my patients are responding to the magnetic compression anastomosis technique.' Gachassin and his team were among the first in .

医学博士,MHCM,奥克斯纳拉斐特综合医疗中心代谢与减重手术医学总监。 “结果令人鼓舞,我对手术中的磁压合技术给我的患者的反应尤其印象深刻。” Gachassin 和他的团队是最早采用该技术的团队之一。

Louisiana

路易斯安那州

to use the MagDI System with the 40mm magnet.

使用带有40毫米磁铁的MagDI系统。

Addition of 50mm MagDI magnet expands opportunities for surgeons and patients

50毫米MagDI磁铁的加入为外科医生和患者拓展了机会。

With the new choice of the 50mm or 40mm magnet size, the MagDI System offers surgeons greater flexibility to tailor procedures to individual patient needs. The larger magnet will be used in the same procedure as the 40mm magnet to facilitate a seamless, non-invasive approach to anastomosis.

通过选择50毫米或40毫米磁体尺寸,MagDI系统为外科医生提供了更大的灵活性,可以根据患者个体需求定制手术方案。较大磁体将与40毫米磁体用于相同的操作中,以促进无缝、非侵入式的吻合方法。

'This expansion reinforces our commitment to pushing the boundaries of minimally invasive, magnetic surgery and providing surgeons with more advanced tools to improve patient outcomes,' said

“此次扩展加强了我们对突破微创磁性手术界限的承诺,并为外科医生提供更先进的工具以改善患者预后,”

Thierry Thaure

蒂埃里·陶尔

, Chief Executive Officer and co-founder of GT Metabolic Solutions.

,GT代谢解决方案公司的首席执行官兼联合创始人。

'We are eager to bring this transformative approach to even more surgeons and patients,' added

“我们渴望将这种变革性的方法带给更多的外科医生和患者,”他补充道。

Michel Gagner

米歇尔·加格内尔

, MD, Chief Medical Officer and co-founder of GT Metabolic Solutions, who created the system. 'The clinical success we've seen so far reinforces the role of magnetic compression for anastomosis in bariatric surgery today and bringing the option of a larger 50mm magnet allows us to broaden the impact of the MagDI System.'.

,医学博士,GT代谢解决方案公司的首席医疗官兼联合创始人,他创建了该系统。“我们迄今为止看到的临床成功进一步巩固了磁压技术在当今减肥手术中的吻合应用,而引入更大的50毫米磁铁使我们能够扩大MagDI系统的影响。”

As demand for less invasive, more efficient surgical techniques grows, GT Metabolic is committed to accelerating the U.S. market release of the MagDI™ System in collaboration with leading surgeons and hospital centers. Clinical evidence continues to support the efficacy of this approach.

随着对创伤更小、更高效手术技术的需求不断增长,GT Metabolic 致力于与领先的外科医生和医院中心合作,加速 MagDI™ 系统在美国市场的发布。临床证据继续支持这种方法的有效性。

To date, there are no reported leaks or bleeds attributed to this sutureless, staple-free technique.

迄今为止,尚未有报道因这种无缝合、无钉合技术而导致的渗漏或出血。

'We are thrilled by the growing interest in the MagDI System and what it means for the future of bariatric surgery,' said

“我们对MagDI系统日益增长的兴趣以及它对减肥手术未来的影响感到非常兴奋,”

Ronald Galovich

罗纳德·加洛维奇

, Vice President Sales & Marketing, GT Metabolic. 'We look forward to expanding opportunities for surgeons who are eager for solutions that enhance anastomosis procedural efficiency while improving patient outcomes. The approval of the 50mm magnet is another step in meeting that demand.'

销售与营销副总裁,GT Metabolic。 “我们期待为那些渴望提高吻合术程序效率同时改善患者预后的外科医生们扩大机会。50毫米磁铁的批准是满足这一需求的又一步。”

About GT Metabolic Solutions Inc.

关于GT Metabolic Solutions Inc.

GT Metabolic Solutions Inc. is leading the world with its development of magnetic compression anastomosis technologies for next-stage minimally invasive procedures. An elegant approach that uses magnets to help achieve anastomosis, the incisionless, sutureless, staple-free technique leaves no foreign material to impede the natural tissue healing process..

GT代谢解决方案公司(GT Metabolic Solutions Inc.)正通过其开发的磁压缩吻合技术引领世界,应用于下一代微创手术。这种优雅的方法利用磁铁辅助实现吻合,无需切口、缝合或钉合,且不留任何异物阻碍自然组织愈合过程。

Working in tandem with renowned global experts, our team has engineered a magnetic compression solution called delayed anastomosis technology (DAT) that surgeons can use to create consistent anastomosis while helping minimize potential complications, such as leaks and bleeds, in challenging applications.

与全球知名专家紧密合作,我们的团队开发了一种名为延迟吻合技术(DAT)的磁压缩解决方案,外科医生可以在复杂应用中使用该技术来实现一致的吻合效果,同时有助于减少诸如泄漏和出血等潜在并发症。

Our solution democratizes the surgical approach to anastomosis. It can be used in procedure staging and is 100% reversible..

我们的解决方案使吻合术的外科手术方法民主化。它可用于手术分期,并且是100%可逆的。

Committed to improving patients' lives and healthcare provider outcomes, GT Metabolic Solutions Inc. is disrupting the market by introducing magnetic compression anastomosis technologies to bariatric, metabolic, and digestive health providers in the U.S. and abroad.

致力于改善患者生活和医疗保健提供者的治疗效果,GT代谢解决方案公司正在通过向美国及海外的减肥、代谢和消化健康领域引入磁压吻合技术,颠覆市场。