GALWAY, Ireland--(BUSINESS WIRE)--Vivasure Medical®, a company pioneering novel fully absorbable technology for percutaneous vessel closure, today announced it has enrolled the 100th patient in its PATCH Clinical Study, a multi-center, single-arm, pivotal study evaluating the safety and efficacy of the Vivasure PerQseal® Closure Device System.

爱尔兰戈尔韦-（BUSINESS WIRE）-VivasureMedical®是一家开创新型完全可吸收技术用于经皮血管闭合的公司，今天宣布它已将第100名患者纳入其贴片临床研究，这是一项多中心，评估VivaSurePerqSeal®闭合装置系统安全性和有效性的单臂关键性研究。

The U.S. Food and Drug Administration (FDA) granted investigational device exemption (IDE) approval earlier this year to advance the PATCH study forward..

美国食品和药物管理局（FDA）今年早些时候批准了研究设备豁免（IDE）批准，以推进补丁研究。。

“We’re grateful to the one hundred patients who have been enrolled in this study to date and the brilliant physician investigators working to gather data about our technology,” said Andrew Glass, Chief Executive Officer of Vivasure Medical. “This marks an important milestone for Vivasure as it brings us closer to our goal of demonstrating PerQseal’s potential in supporting successful percutaneous cardiovascular therapies.”.

Vivasure Medical首席执行官安德鲁·格拉斯（Andrew Glass）说：“我们感谢迄今为止参加这项研究的100名患者以及致力于收集有关我们技术数据的杰出医师研究人员。”。“这标志着Vivasure的一个重要里程碑，因为它使我们更接近于展示PerQseal支持成功的经皮心血管治疗潜力的目标。”。

Large hole arterial access is required for clinicians to perform numerous life-saving percutaneous cardiovascular procedures such as transcatheter aortic valve replacement (TAVR), thoracic and abdominal endovascular aneurysm repair (TEVAR and EVAR), and the use of a cardiac assist device (CAD). The current approach to large-diameter arterial closure is a surgical repair or the use of suture- or collagen-based closure devices.

临床医生需要进行大量挽救生命的经皮心血管手术，如经导管主动脉瓣置换术（TAVR），胸腹血管内动脉瘤修补术（TEVAR和EVAR）以及使用心脏辅助装置（CAD）。目前用于大直径动脉闭合的方法是手术修复或使用基于缝合线或胶原的闭合装置。

Both can result in major vascular complications, such as vessel distortion at the closure site, which may lead to stenosis, thrombus formation or abrupt closure..

两者都可能导致严重的血管并发症，如闭合部位的血管扭曲，可能导致狭窄，血栓形成或突然闭合。。

PerQseal is designed to be the first sutureless, fully absorbable synthetic implant for large-bore vessel punctures. Its low profile patch can be placed from inside the vessel and is intended to make deployment simpler and more controlled than conventional closure techniques. Clinical studies to date have shown a low complication rate and high technical success..

PerQseal设计为第一个用于大口径血管穿刺的无缝线，完全可吸收的合成植入物。它的低调补丁可以从容器内部放置，旨在使部署比传统的封闭技术更简单，更受控制。迄今为止的临床研究表明，并发症发生率低，技术成功率高。。

The PATCH pivotal study will enroll and follow up to 188 patients across the U.S. and Europe. The company intends to use the clinical study results to support an FDA pre-market approval submission as well as multinational commercial launch of the PerQseal system for large hole vessel closure.

PATCH pivotal研究将在美国和欧洲招募并随访188名患者。该公司打算利用临床研究结果来支持FDA上市前批准提交以及跨国商业推出PerQseal系统以关闭大孔血管。

About Vivasure Medical

关于Vivasure Medical

Based in Galway, Ireland, Vivasure is focused on the development of advanced polymer implants and delivery systems, primarily focused on minimally invasive vessel closure in cardiology, interventional radiology and vascular surgery. Vivasure operates a fully integrated R&D and ISO 13485 certified manufacturing facility and is backed by leading international medtech investors.

位于爱尔兰戈尔韦的Vivasure专注于开发先进的聚合物植入物和输送系统，主要集中在心脏病学，介入放射学和血管外科的微创血管闭合。Vivasure拥有完全集成的研发和ISO 13485认证的制造工厂，并得到领先的国际medtech投资者的支持。

For more information, please visit www.vivasuremedical.com..

欲了解更多信息，请访问www.vivasuremedical.com。。

PerQseal® and PerQseal®+ are not available for sale in the United States.

PerQseal®和PerQseal®+在美国不销售。