Acera Surgical通过新的FDA软组织加固许可，扩大了Restrata®的应用范围-动脉网

Acera Surgical Broadens Reach of Restrata® with New FDA Clearance for Soft Tissue Reinforcement

CISION 等信源发布 2025-06-25 22:49

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ST. LOUIS

圣路易斯

，

June 25, 2025

2025年6月25日

/PRNewswire/ -- Acera Surgical, a pioneer in synthetic electrospun materials for soft tissue repair, today announced it has received an additional U.S. Food and Drug Administration (FDA) 510(k) clearance for Restrata

/PRNewswire/ -- 作为软组织修复中合成电纺材料的先驱，Acera Surgical公司今天宣布其Restrata产品已获得美国食品药品监督管理局（FDA）的额外510(k)许可。

, a fully synthetic, fully resorbable electrospun matrix. This new clearance broadens the clinical utility of the

，一种完全合成、完全可吸收的电纺基质。这一新的审批拓宽了该产品的临床应用范围。

Restrata platform

限制平台

, now supporting soft tissue reinforcement applications in addition to its previously cleared indications for wound healing. This clearance applies to both Restrata Sheet and Restrata Meshed products.

`,现在除了之前获批的伤口愈合适应症外，还支持软组织加固应用。该许可适用于Restrata Sheet和Restrata Meshed产品。`

The expanded indications allow for implantation of Restrata to reinforce soft tissue where weakness exists, including beneath primary skin closures in plastic and reconstructive procedures, as well as in closures at risk of dehiscence or wound breakdown.

扩展的适应症允许植入Restrata以加强软组织薄弱部位，包括在整形和重建手术中的主要皮肤闭合处下方，以及有裂开或伤口崩解风险的闭合处。

'This clearance marks a significant step forward, not only for our clinical partners but also for the broader commercial trajectory of the Restrata platform,' said

“这一许可标志着一个重要的进步，不仅对于我们的临床合作伙伴而言，也对Restrata平台更广泛的商业化进程具有重要意义，”

Mike Finegan

迈克·法因根

, Chief Executive Officer of Acera Surgical.

，Acera Surgical的首席执行官。

'By addressing both soft tissue healing and reinforcement, we're delivering a truly versatile solution that meets a diverse set of surgical needs with one synthetic, resorbable technology.'

“通过解决软组织愈合和加固问题，我们提供了一种真正多功能的解决方案，以一种合成的、可吸收的技术满足了多样化的手术需求。”

Invented and manufactured in

发明并制造于

the United States

美国

, Restrata is engineered by electrospinning bioresorbable synthetic polymers, each with well-established safety profiles, into a matrix form. Once implanted, the device provides structural support to surrounding soft tissues before fully resorbing within three to four weeks, offering acute reinforcement to soft tissue during the critical healing phase when risk of post-operative complications, such as dehiscence, are highest..

，Restrata 采用电纺生物可吸收合成聚合物制成，每种聚合物都具有成熟的安全性记录，并形成矩阵结构。一旦植入，该装置在三到四周内完全吸收之前为周围软组织提供结构支撑，在术后并发症（如裂开）风险最高的关键愈合阶段为软组织提供即时的加固。

'Surgical site dehiscence and wound breakdown represents a significant challenge, particularly in orthopedic and reconstructive surgery,' said

“手术部位裂开和伤口崩解是一个重大挑战，特别是在骨科和重建手术中，”他说。

Dr.

博士

Matthew MacEwan

马修·麦克尤恩

, Co-Founder and Chief Scientific Officer of Acera Surgical.

，Acera Surgical的联合创始人兼首席科学官。

'Restrata addresses this unmet clinical need by providing early mechanical support to protect closures when they're most vulnerable, then resorbing as native tissue strength returns.'

“Restrata 通过在闭合最脆弱时提供早期机械支持来满足这一未被满足的临床需求，然后随着原生组织强度的恢复而被吸收。”

With this latest FDA clearance, Acera Surgical now offers one product, Restrata, with two indications, supporting the full continuum of soft tissue reconstruction 'head-to-toe, in-and-out.' From external wound healing to internal soft tissue reinforcement, this clearance positions the company for continued clinical adoption, expansion into new surgical specialties, and accelerating commercial growth..

随着这一最新的FDA批准，Acera Surgical现在提供一种产品——Restrata，具有两种适应症，支持软组织重建的整个连续过程，“从头到脚，由内至外”。从外部伤口愈合到内部软组织加固，此次批准使该公司能够继续推动临床应用，拓展新的外科专业领域，并加速商业增长。

About Acera Surgical

关于Acera Surgical

Acera Surgical, headquartered in

Acera Surgical，总部位于

St. Louis, Missouri

密苏里州圣路易斯市

, is a bioscience company and leader in electrospun technology innovation for regenerative medicine. The company develops and commercializes Restrata, a fully synthetic electrospun fiber matrix that mimics native human extracellular architecture to support soft tissue healing across a range of surgical applications..

是一家生物科学公司，是再生医学领域电纺技术创新的领导者。该公司开发并商业化了Restrata，这是一种完全合成的电纺纤维基质，可模拟天然的人类细胞外架构，以支持各种外科应用中的软组织愈合。

For more information, visit

欲了解更多信息，请访问

www.acera-surgical.com

。

Media Contact:

媒体联系人：

Leslie Branon

莱斯利·布兰农

512-567-9181

leslieb@medvoicepr.com

莱斯利·B@medvoicepr.com