The gel system offers consistent performance from hand to foot and ankle surgeries. Credit: PeopleImages.com – Yuri A / Shutterstock.

该凝胶系统在从手部到足部和踝关节的手术中表现出一致的性能。图片来源：PeopleImages.com – Yuri A / Shutterstock。

The US Food and Drug Administration (FDA) has granted 510(k) clearance to TYBR Health’s bioresorbable B3 GEL system, a barrier intended for protecting healing tissues and preserving mobility post-surgery, which involves ligaments, tendons, and skeletal muscle.

美国食品药品监督管理局（FDA）已授予TYBR Health的生物可吸收B3 GEL系统510(k)许可，该屏障旨在保护愈合组织并维持术后活动能力，涉及韧带、肌腱和骨骼肌。

This gel temporarily separates tissues during the early healing phase, without hindering the natural healing process, while maintaining surgical precision.

这种凝胶在早期愈合阶段暂时分离组织，不会妨碍自然愈合过程，同时保持手术精度。

Composed of a naturally derived extracellular matrix, B3 GEL is applied using the company’s integrated mixer-applicator system.

由天然衍生的细胞外基质组成的B3凝胶，使用该公司的集成混合施用器系统进行应用。

Its flowable nature allows it to conform to complex anatomical structures and is suitable for both open and minimally invasive surgeries.

其流动性使其能够适应复杂的解剖结构，适用于开放手术和微创手术。

The blue gel ensures visibility during placement and is fully resorbable, leaving no residual material.

蓝色凝胶在放置过程中确保可见性，并且完全可吸收，不留任何残留物。

According to the company, the gel stays in place during the first week post-surgery, safeguarding tissues through the acute inflammation and fibroblast proliferation phases.

据该公司称，这种凝胶在术后第一周保持原位，通过急性炎症和成纤维细胞增殖阶段保护组织。

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美国关税正在变化——你会做出反应还是提前预测？

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It metabolises naturally over two to three weeks, ensuring protection when necessary and full clearance once healing is done.

它在两到三周内自然代谢，确保在必要时提供保护，并在愈合完成后完全清除。

TYBR noted that the B3 GEL System’s protective capabilities extend across various tendon and ligament complexes in the body, offering consistent performance from hand to foot and ankle surgeries.

TYBR指出，B3 GEL系统在身体各个肌腱和韧带复合体上均展现出保护能力，从手部到足部及踝关节手术中均能提供始终如一的表现。

It forms a protective barrier, preventing restrictive scar tissue while aiding in healing.

它形成了一个保护屏障，防止限制性疤痕组织的形成，同时有助于愈合。

The company anticipates commercial sales to begin by the end of this year.

公司预计商业销售将在今年年底前开始。

TYBR Health CEO and co-founder Tim Keane said: “When we started TYBR, it was with a clear purpose: to solve a real, overlooked problem in surgical recovery.

TYBR Health首席执行官兼联合创始人蒂姆·基恩表示：“我们创立TYBR时，就有一个明确的目标：解决手术康复过程中一个真实却被忽视的问题。

“Too often, healing goes unprotected once the procedure ends. B3 GEL is designed to fill that gap—working with the body’s biology to protect tissue planes and give surgeons a way to safeguard patient outcomes during the critical early phase of recovery.”

“一旦手术结束，愈合过程常常得不到保护。B3凝胶旨在填补这一空白——与人体的生物学机制协同工作，保护组织层面，并为外科医生提供一种在恢复初期关键阶段保障患者预后的方法。”

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