A Prospective, Multicenter, Non-Blinded, Non-Randomized Pivotal Study of the Fenestrated TREO Stent-Graft System in Subjects With Abdominal Aortic Aneurysms Requiring a Fenestrated Graft and Suitable for Endovascular Repair
The goal of this clinical trial is to learn if the Fenestrated TREO Stent-Graft System works to treat abdominal aneurysms in adults. An abdominal aneurysm is a bulge in the main blood vessel (the aorta) which carries blood from the heart, through the chest and abdomen. It will also learn about the safety of Fenestrated TREO Stent-Graft System.
The main question it aims to answer is: Can the the Fenestrated TREO Stent-Graft System be used to treat participants with a specific type of abdominal aneurysm called a juxtarenal abdominal aortic aneurysm?
Participants will: Have the the Fenestrated TREO Stent-Graft System implanted via an endovascular surgical procedure and visit the hospital for a follow up period of 5 years, for checkups, tests and imaging scans.
/ Active, not recruitingN/A Thoraflex Hybrid and Relay Extension Post-Approval Study
The goal of this observational study is to evaluate the Thoraflex Hybrid device alone and in combination with the RelayPro NBS stent-graft in the treatment of aortic disease affecting the aortic arch and descending aorta with or without involvement of the ascending aorta.
Patients who undergo treatment with the Thoraflex Hybrid device with or without extension with a RelayPro NBS stent-graft will be eligible for enrolment and study activities and follow-up regime will follow standard care at each participating site.
Participant involvement in the study will last for a total of 10 years from the point at which the Thoraflex Hybrid device is placed.
/ Active, not recruitingN/AIIT Cerebral Hemodynamics and Microemboli During Placement of Relay®Branch Thoracic Stent-Graft System
This is an observational cohort study addressing the incidence of cerebral microemboli and alterations of cerebral hemodynamic physiology of the Relay®Branch thoracic stent-graft system.
100 项与 Bolton Medical, Inc. 相关的临床结果
0 项与 Bolton Medical, Inc. 相关的专利(医药)
索引号
JGXX-2026-10063
主题分类
监管信息
/ 责令召回信息
标题
博顿医疗有限公司Bolton Medical, Inc.对胸主动脉覆膜支架系统RelayPro Thoracic Stent-Graft System主动召回
发布日期
2026-07-22 泰尔茂医疗产品(上海)有限公司报告,由于博顿医疗有限公司Bolton Medical, Inc.发现胸主动脉覆膜支架系统RelayPro Thoracic Stent-Graft System产品存在问题,涉及产品可能存在近端卡扣与外控管断开连接的问题,这可能导致支架移植物无法从输送系统中释放。生产商博顿医疗有限公司Bolton Medical, Inc.正在对其生产的胸主动脉覆膜支架系统RelayPro Thoracic Stent-Graft System(注册证号:国械注进20253130155)主动召回。召回级别为一级召回。涉及产品的型号、规格及批次等详细信息见《医疗器械召回事件报告表》。 附件:医疗器械召回事件报告表 2026年7月21日泰尔茂医疗产品(上海)有限公司召回报表.pdf
100 项与 Bolton Medical, Inc. 相关的药物交易
100 项与 Bolton Medical, Inc. 相关的转化医学