/PRNewswire/ -- Aquedeon Medical Inc. (AMI) is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved the expansion of its Investigational Device Exemption (IDE) clinical trial evaluating the Duett Vascular Graft System (Duett System), a novel device designed to facilitate open surgical repair of aortic arch aneurysms and dissections, including hybrid procedures..

/PRNewswire/ -- Aquedeon Medical Inc.（AMI）欣然宣布，美国食品和药物管理局（FDA）已批准扩展其研究器械豁免（IDE）临床试验，以评估Duett血管移植物系统（Duett系统）。这是一种新型设备，旨在促进主动脉弓动脉瘤和夹层的开放手术修复，包括混合手术。

AMI is developing the Duett System to address a critical need in open surgical thoracic aortic arch reconstruction, a complex and high-risk procedure typically performed during deep hypothermic circulatory arrest (DHCA) while the patient is on cardiopulmonary bypass. DHCA duration is a critical factor that directly impacts patient outcomes..

AMI公司正在开发Duett系统，以应对开胸主动脉弓重建手术中的一个关键需求。这种手术复杂且风险很高，通常在患者接受心肺分流术时，在深低温停循环（DHCA）期间进行。DHCA的持续时间是直接影响患者预后的关键因素。

During arch reconstruction, the diseased portion of the aorta is excised and replaced with a prosthetic polyester graft. This graft is sutured to the native aorta, and each of its branches is connected to the three major arch vessels supplying blood to the brain and upper body. This portion of the surgery—suturing the graft branches to native vessels—is technically demanding and time-consuming, contributing to prolonged DHCA, which is associated with increased neurological and cardiac risks..

在主动脉弓重建过程中，病态的主动脉部分会被切除，并用聚酯人工血管移植物替代。该移植物被缝合到原生主动脉上，其每个分支都连接到供应大脑和上半身血液的三大弓部血管。手术的这一部分——将移植物分支缝合到原生血管上——技术要求高且耗时，导致深低温停循环（DHCA）时间延长，而这与较高的神经和心脏风险相关。

The Duett System is engineered to simplify and accelerate the vascular anastomosis process, with the goal of reducing DHCA duration and re-establishing cerebral perfusion more rapidly.

杜埃特系统旨在简化和加速血管吻合过程，目标是缩短DHCA持续时间并更快恢复脑灌注。

AMI launched its two-stage IDE clinical trial in 2024 to evaluate the safety and effectiveness of the Duett System. With the recent FDA approval, the study will now expand to enroll up to 90 patients across additional clinical sites in

AMI于2024年启动了两阶段IDE临床试验，以评估Duett系统的安全性和有效性。随着最近FDA的批准，该研究现在将扩展到在更多的临床站点招募多达90名患者。

the United States

美国

. This expansion aims to further validate the system's clinical benefits and procedural efficiency.

。此次扩展旨在进一步验证该系统的临床效益和手术效率。

'It is exciting that Aquedeon has received FDA approval to expand the Duett IDE study to 90 patients. Open aortic arch surgery is complex and technically demanding. The Duett technology has the potential to transform the field by providing aortic surgeons with an innovative tool to facilitate arch reconstruction and enhance care for patients with aortic disease.

“令人兴奋的是，Aquedeon 已获得 FDA 批准，将 Duett IDE 研究扩展至 90 名患者。开放性主动脉弓手术复杂且技术要求高。Duett 技术有潜力通过为主动脉外科医生提供一种创新工具来促进弓部重建，从而改变这一领域，并提升主动脉疾病患者的护理水平。

We look forward to continued investigation with this novel technology,' said Dr. .

我们期待利用这项新技术进行持续的研究，’博士说道。

University of Pennsylvania

宾夕法尼亚大学

, Principal Investigator.

，首席研究员。

'This milestone brings us one step closer to improving outcomes for patients undergoing complex aortic arch reconstruction,' said

“这一里程碑使我们在改善接受复杂主动脉弓重建手术患者的预后方面又迈进了一步，”

Tom Palermo

汤姆·帕勒莫

, Chief Operating Officer of Aquedeon Medical. 'We are grateful for the continued support of our clinical partners and the FDA as we advance the Duett System through the next stage of evaluation.'

Aquedeon Medical的首席运营官表示：“随着我们将Duett系统推进到下一阶段的评估，我们感谢临床合作伙伴和FDA的持续支持。”