AngioDynamics today announced it received FDA 510(k) clearance for its NanoKnife System for prostate tissue ablation in patients with intermediate-risk prostate cancer.

AngioDynamics今天宣布，其用于中危前列腺癌患者前列腺组织消融的纳米刀系统获得FDA 510（k）许可。

The clearance follows the company’s completion of the pivotal PRESERVE clinical study, which enrolled 121 patients across 17 sites and was completed in collaboration with the Society of Urologic Oncology Clinical Trials Consortium.

在该公司完成关键的PRESERVE临床研究之后，该研究招募了17个地点的121名患者，并与泌尿肿瘤学会临床试验联盟合作完成。

According to the company, the study demonstrated the system’s safety and effectiveness, with 84% of patients free from clinically significant in-field disease at 12 months post-procedure. Additionally, the study reported favorable quality-of-life outcomes, including short-term urinary continence preservation and minimal reduction in erectile function..

据该公司称，该研究证明了该系统的安全性和有效性，84%的患者在手术后12个月没有临床上显着的现场疾病。此外，该研究报告了良好的生活质量结果，包括短期尿失禁保存和勃起功能的最小程度降低。。

“We are incredibly proud to receive FDA clearance for the NanoKnife System’s use in prostate tissue,” AngioDynamics President and CEO Jim Clemmer said in a news release. “This milestone is the first step in recognizing our vision to become the standard, function-preserving treatment for men with prostate tumors.

AngioDynamics总裁兼首席执行官吉姆·克莱默（JimClemmer）在新闻稿中表示：“我们非常自豪地获得FDA批准，将纳米刀系统用于前列腺组织。”。“这一里程碑是认识到我们的愿景的第一步，我们的愿景是成为前列腺肿瘤男性的标准，保留功能的治疗方法。

The NanoKnife System minimizes the life-altering complications often associated with traditional treatments by selectively targeting prostate tissue while preserving critical functions.”.

纳米刀系统通过选择性靶向前列腺组织同时保留关键功能，最大限度地减少了与传统治疗相关的改变生命的并发症。”。

More about the NanoKnife System

关于纳米刀系统的更多信息

The NanoKnife System uses non-thermal, radiation-free irreversible electroporation (IRE) technology to precisely ablate prostate tissue. It offers clinicians and patients a minimally invasive alternative to traditional surgery or radiotherapy.

纳米刀系统使用非热，无辐射的不可逆电穿孔（IRE）技术精确消融前列腺组织。它为临床医生和患者提供了传统手术或放疗的微创替代方案。

AngioDynamics said NanoKnife’s ablation approach aims to reduce recovery times and preserve urinary and sexual function. It also addresses some of the common concerns associated with prostate cancer treatments.

AngioDynamics表示，纳米刀的消融方法旨在减少恢复时间并保留泌尿和性功能。它还解决了与前列腺癌治疗相关的一些常见问题。

Prostate cancer is the second most common cancer in men globally, according to the company. There are 1.5 million cases diagnosed annually, and many patients seek alternatives to radical treatments that can cause significant long-term side effects.

据该公司称，前列腺癌是全球男性第二大常见癌症。每年诊断出150万例病例，许多患者寻求可能导致严重长期副作用的根治性治疗的替代方案。

AngioDynamics plans to support physicians’ adoption of the NanoKnife System through comprehensive training and education and other outreach initiatives to inform patients of their options.

AngioDynamics计划通过全面的培训和教育以及其他外联举措来支持医生采用纳米刀系统，以告知患者他们的选择。

“These efforts are designed to accelerate the adoption of the NanoKnife System, redefine the standard of care for prostate health, and deliver treatment outcomes that patients and physicians need. AngioDynamics is committed to driving meaningful impact through this revolutionary technology, providing new hope to patients and improved quality of life,” Clemmer said..

克莱默说：“这些努力旨在加速纳米刀系统的采用，重新定义前列腺健康护理标准，并提供患者和医生所需的治疗结果。血管动力学致力于通过这项革命性技术推动有意义的影响，为患者提供新的希望，提高生活质量。”