/PRNewswire/ -- Embolization, Inc., has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Nitinol Enhanced Device (NED).

/PRNewswire/ -- Embolization, Inc. 已获得美国食品药品监督管理局 (FDA) 的 510(k) 许可，用于其镍钛诺增强装置 (NED)。

The NED is a vascular embolization device intended for arterial and venous embolization in peripheral vasculature. Vascular embolization is a minimally invasive procedure where a physician intentionally blocks a blood vessel using tiny materials such as coils, particles or glue. This stops bleeding, reduces blood flow to tumors, or prevents damage from abnormal blood vessels, and is often used instead of surgery because it's safer, quicker to recover from and very precise. .

NED 是一种血管栓塞装置，旨在用于外周血管的动脉和静脉栓塞。血管栓塞是一种微创手术，医生通过使用微小的材料（如线圈、颗粒或胶水）有意地阻塞血管。这种方法可以止血、减少对肿瘤的血液供应，或防止异常血管造成的损害，且因其比手术更安全、恢复更快、非常精准，常被用作手术的替代方案。

Using proprietary shape-memory biocompatible polymers, Embolization's coil devices achieve better vascular occlusion while minimizing artifacts in CT and MRI imaging that occur with traditional metal devices.

使用专有的形状记忆生物相容性聚合物，栓塞线圈装置能够实现更好的血管闭塞，同时最大限度地减少传统金属装置在CT和MRI成像中产生的伪影。

Embolization's development represents the next generation in embolic coils, says

栓塞术的发展代表了栓塞线圈的下一代，

Jim Kasic

吉姆·卡西克

, CEO. 'The 510(k) clearance – which gives the company the ability to market the device – is a defining moment and major step forward in bringing this important device to the medical community, and ultimately, to the patients who will benefit.'

，首席执行官。“510(k)许可——使公司能够将该设备推向市场——是一个决定性的时刻，也是将这一重要设备带给医疗界，最终带给将受益的患者的重要的一步。”

Shorter occlusion times, tighter coil packs, minimal imaging artifact

更短的遮挡时间，更紧密的线圈组，最小的成像伪影

Kasic notes that the NED will be the only polymer-based coil on the market; all other available coils are metal-based. 'Our pre-clinical work has shown that the coils have substantially reduced imaging artifact, significantly outperforming competitive devices,' he says. The coils, he adds, are still radiopaque under fluoroscopy even though the CT/MRI imaging artifact is minimal..

卡西奇指出，NED 将是市面上唯一的聚合物基线圈；所有其他可用的线圈都是基于金属的。“我们的临床前研究表明，这些线圈大大减少了成像伪影，性能显著优于竞争设备，”他说道。他补充说，尽管 CT/MRI 成像伪影极小，这些线圈在透视下仍然具有显影性。

Studies also show shorter occlusion times and tighter coil packs. 'With fewer devices per procedure, lower recanalization rates and lower manufacturing costs, I believe the Embolization coil will substantially replace existing metal options,' states Kasic.

研究还显示，闭塞时间更短，线圈组更紧密。Kasic表示：“由于每次手术使用的器械更少、再通率更低以及制造成本更低，我相信栓塞线圈将大幅取代现有的金属选项。”

Further detailing use of the NED, Kasic explains that peripheral vasculature conditions such as great saphenous insufficiency, renal aneurism and other vessel anomalies require blocking the flow in the vein, artery or aneurism to prevent further damage, and to promote alternative flow pathways and healing.

进一步详细说明NED的使用时，Kasic解释道，大隐静脉功能不全、肾动脉瘤及其他血管异常等外周血管状况需要阻断静脉、动脉或动脉瘤中的血流，以防止进一步损伤，并促进替代血流路径和愈合。

Interventional radiologists use surgical ligation when open surgery is indicated, but minimally invasive insertion of a coil into the vasculature has become a common approach to avoid open surgery..

当需要进行开放手术时，介入放射科医生会使用外科结扎术，但为了避开开放手术，将线圈微创插入血管已成为一种常见方法。

Clinical benefits

临床效益

Use of implantable metal coils has been a preferred approach, he says, but is less than ideal due in large part to the metal coil's interference with imaging by CT scan or MRI. Metal coils can also be subject to failure through recanalization, which allows blood to flow again into the unwanted pathway. .

他说，使用可植入金属线圈一直是一种首选方法，但由于金属线圈在很大程度上会干扰CT扫描或核磁共振成像，因此并不理想。金属线圈还可能因再通而失效，导致血液再次流入不需要的通路。

In animal studies, Embolization's non-metal coils benefits include:

在动物研究中，栓塞的非金属线圈的好处包括：

Reduction in shadowing or obscuration on imaging scans

影像扫描中阴影或遮挡的减少

Easier repeat embolizations

更容易重复栓塞

Faster, more reliable embolization

更快、更可靠的栓塞术

Simplicity and easy of use, through a patented 1mm diameter implantation tool

通过直径1毫米的专利植入工具，实现简洁与易用性

Commercialization

商业化

With 510(k) clearance, Embolization will move toward commercialization and market introduction of the coil device. "We are more than anxious to move forward and participate in this growing market," states Kasic. The global embolization devices market was valued at nearly $3.1 billion in 2024, and is projected to reach $5.9 billion by 2031.

凭借510(k)审批，Embolization公司将迈向线圈装置的商业化和市场推广。“我们非常渴望向前迈进，参与到这个不断增长的市场中来，”Kasic表示。2024年，全球栓塞设备市场规模接近31亿美元，预计到2031年将达到59亿美元。

The market for the embolization coils segment was valued at nearly $1.9 billion in 2024 and is projected to reach almost $3.7 billion by 2031.*

2024 年栓塞线圈市场的规模接近19 亿美元，预计到 2031 年将达到近37 亿美元。 *

Embolization worked with Boulder iQ and its sister company, Boulder Regulatory and Quality, for the development and regulatory work for the NED. An expert contract consulting firm, the Boulder iQ family provides full, integrated services that life science developers need to bring their products to market.

Embolization 与Boulder iQ 及其姊妹公司Boulder Regulatory and Quality合作，负责 NED 的开发和监管工作。作为一家专业的合同咨询公司，Boulder iQ 家族为生命科学开发者提供将产品推向市场所需的全方位综合服务。