艾瑞弗医疗公司获得FDA批准，用于进行关键性临床研究，测试艾瑞弗肺药物涂层球囊治疗良性中央气道狭窄的效果-动脉网

Airiver Medical Receives IDE Approval from the FDA for Pivotal Clinical Study of the Airiver Pulmonary Drug Coated Balloon to Treat Benign Central Airway Stenosis

CISION 等信源发布 2025-08-27 22:00

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The nationwide study will assess the safety and efficacy of the technology that combines standard balloon dilation to open the respiratory tract with drug delivery designed to maintain symptom relief

这项全国性研究将评估结合标准球囊扩张以打开呼吸道和旨在维持症状缓解的药物输送技术的安全性和有效性。

BROOKLYN PARK, Minn.

明尼苏达州布鲁克林公园

，

Aug. 27, 2025

2025年8月27日

/PRNewswire/ --

Airiver Medical

爱瑞尔医疗

, a clinical stage company developing technologies to help patients who suffer from certain respiratory tract conditions, received investigational device exemption (IDE) approval from the U.S. Food and Drug Administration (FDA), enabling the company to begin a pivotal clinical trial of the Airiver Pulmonary Drug Coated Balloon (DCB) to treat central airway stenosis.

，一家临床阶段的公司，正在开发帮助某些呼吸道疾病患者的技术，获得了美国食品药品监督管理局（FDA）的研究设备豁免（IDE）批准，使该公司能够开始进行Airiver肺药物涂层球囊（DCB）治疗中央气道狭窄的关键临床试验。

This is the company's first IDE study submission and approval..

这是该公司首次提交并获批的IDE研究。

The study will enroll up to 200 patients suffering from central airway stenosis and is being conducted across the country to assess the safety and efficacy of the Airiver DCB which combines standard balloon dilation to open the respiratory tract with proprietary drug delivery designed to maintain symptom relief and prevent recurrence.

该研究将招募多达200名中央气道狭窄患者，并在全国范围内开展，以评估Airiver DCB的安全性和有效性。该设备结合了标准球囊扩张术来打开呼吸道，并通过专有药物输送设计以维持症状缓解并防止复发。

The proprietary coating allows for very localized paclitaxel delivery to the stenosis, while limiting levels in the surrounding healthy tissue. The trial is testing the Airiver DCB against standard of care bare balloon dilation. .

这种专有涂层能够将紫杉醇非常局部地递送到狭窄部位，同时限制周围健康组织中的药物水平。该试验正在测试Airiver DCB与标准护理裸球囊扩张的对比效果。

'As it stands, there is no optimal treatment of recurrent airway stenosis available as part of today's treatment paradigm,' said

“就目前而言，当今的治疗模式中尚无最佳的复发性气道狭窄治疗方法，”

Lixiao Wang

李晓王

, founder, chief executive officer and chief technology officer for Airiver Medical. 'Securing IDE approval for this study is extremely exciting because the Airiver DCB has the potential to establish a new minimally invasive and durable treatment option preventing recurrence for patients suffering from this serious condition, which has not yet been accomplished.'.

，Airiver Medical的创始人、首席执行官兼首席技术官。“为这项研究获得IDE批准令人非常兴奋，因为空河药物涂层球囊（DCB）有潜力为患有这种严重疾病的患者提供一种新的微创且持久的治疗选择，防止复发，这在目前尚未实现。”

Central airway stenosis, otherwise defined as airway narrowing, is often associated with prolonged intubation, tracheostomy, stenting, tuberculosis or lung transplant. There are approximately 100,000 tracheo-bronchial stenting and dilation procedures performed annually within

中央气道狭窄，又称气道缩窄，常与长期插管、气管切开术、支架置入、结核或肺移植相关。每年大约进行10万例气管支气管支架置入和扩张手术。

the United States

美国

. The study will serve as the basis for Airiver Medical's regulatory submission to the FDA and eventual commercialization of the Airiver Pulmonary DCB in the U.S.

该研究将作为空河医疗公司向美国食品药品监督管理局（FDA）提交监管申请并最终在美国实现空河肺部药物涂层球囊（DCB）商业化的基础。

The Airiver DCB is an investigational device for the use of treating benign central airway stenosis. The Airiver DCB has not received marketing authorization from the FDA and is not available for sale in

Airiver DCB 是一种用于治疗良性中央气道狭窄的研究性装置。Airiver DCB 尚未获得 FDA 的上市许可，也不可供出售。

the United States

美国

。

About Airiver Medical

关于爱瑞医疗

Airiver Medical is a clinical stage company developing technologies to help patients who suffer from certain respiratory tract conditions. The company aims to improve the current standard of care for central airway stenosis and chronic rhinosinusitis. Airiver Medical's Drug Coated Balloon could offer a new solution for these conditions, potentially creating sustained patency, better outcomes and fewer treatments..

Airiver Medical是一家临床阶段的公司，致力于开发技术以帮助患有某些呼吸道疾病的患者。该公司旨在改善当前对中央气道狭窄和慢性鼻窦炎的护理标准。Airiver Medical的药物涂层球囊可能为这些疾病提供一种新的解决方案，有望实现持续通畅、更好的疗效以及更少的治疗次数。

For more information, please visit

更多信息，请访问

www.airiver.com

。

Media Contact:

媒体联系人：

Hyedi Nelson

海迪·纳尔逊

hyedi@bellmontpartners.com

(651) 757-7054

SOURCE Airiver Medical