Akura Medical, a Shifamed portfolio company, announced today that the FDA granted its Katana system investigational device exemption (IDE).

Shifamed投资组合公司Akura Medical今天宣布，FDA批准其Katana系统研究设备豁免（IDE）。

IDE means Akura can begin the QUADRA-PE study evaluating the thrombectomy system in patients with acute pulmonary embolism (PE). Dr. Sanjum Sethi (Columbia University Medical Center) and Dr. Ann Gage (Tristar Centennial Medical Center) serve as co-principal investigators.

IDE意味着Akura可以开始QUADRA-PE研究，评估急性肺栓塞（PE）患者的血栓切除系统。Sanjum Sethi博士（哥伦比亚大学医学中心）和Ann Gage博士（Tristar Centennial Medical Center）担任联合首席研究员。

The company expects QUADRA-PE to enroll up to 118 patients with clinically significant acute PE at up to 26 global sites. It has a primary effectiveness endpoint of reduction in right ventricular/left ventricular (RV/LV) ratio from baseline to 48 hours post-procedure as assessed by CT angiography. The primary safety endpoint is the composite rate of major adverse events (MAEs) within 48 hours post-procedure..

该公司预计QUADRA-PE将在全球26个地点招募多达118名具有临床意义的急性PE患者。通过CT血管造影评估，它具有从基线到术后48小时降低右心室/左心室（RV/LV）比率的主要有效性终点。主要安全终点是术后48小时内主要不良事件（MAEs）的综合发生率。

Los Gatos, California-based company designed its Katana system with a bi-directional, low-profile sheath. It facilitates smoother navigation in complex vasculature and enables contrast injection without requiring catheter exchanges. Additionally, the system features high-velocity saline jets. The company engineered these to effectively break up clots independently of morphology and prevent catheter clogging for procedural efficiency..

这家总部位于加利福尼亚州洛斯加托斯的公司设计了一种带有双向薄型护套的Katana系统。它有助于在复杂的脉管系统中进行更平滑的导航，并且可以在不需要更换导管的情况下进行对比剂注射。。该公司设计了这些产品，以有效地分解凝块，而不依赖于形态，并防止导管堵塞以提高手术效率。

Additionally, Akura designed Katana with sensors that provide real-time pulmonary artery pressure data. This offers insights into procedure progress. The system’s sentinel console displays clot engagement and blood loss to inform the physician and potentially minimize uncertainty.

此外，Akura设计的Katana带有传感器，可提供实时肺动脉压力数据。这提供了对程序进展的见解。该系统的哨兵控制台显示凝块接合和失血，以通知医生，并可能最大限度地减少不确定性。

“The IDE approval of QUADRA-PE marks a significant milestone in the company’s journey toward providing physicians with a next-generation solution for treating acute pulmonary embolism,” said Murali Srivathsa, president and CEO, Akura Medical. “We designed the Katana System based on extensive feedback from physicians who shared their need for a thrombectomy system that minimized the difficulty of getting to the clot, removed all types of clots without catheter clogging and provided greater procedural feedback.

。“我们根据医生的广泛反馈设计了Katana系统，这些医生分享了他们对血栓切除系统的需求，该系统可以最大程度地减少血栓形成的难度，去除所有类型的血栓而不会堵塞导管，并提供更大的程序反馈。

We look forward to working with our clinical investigators to demonstrate our system’s efficacy.”.

我们期待着与我们的临床研究人员合作，以证明我们的系统的有效性。”。