WATCHMAN is a one-time, minimally invasive procedure for NVAF patients with a lifetime of stroke risk reduction without the bleeding risk associated with OACs.
WATCHMAN™循证医学证据 WATCHMAN是唯一具有4800患者年的随访数据以及多个随机对照临床试验和注册研究的左心耳封堵器。临床试验Pilot样本量 66800460150461 中心数 85926441随访402患者年随访超过6年 关键点 PROTECTAF CAP(ContinuedASAPPREVAILCAP2 TotalPatients:AccessRegistry)随访超过4年平均随访2.3年3 显著改善手术...
WATCHMAN FLX Device DFU File Type: PDF Directions for Use of the WATCHMAN FLX Device. WATCHMAN FLX Device Patient Guide File Type: PDF Electronic specification sheet designed for patients with details regarding device, procedure and post-procedure information. Does not include WATCHMAN FLX Implant Car...
Next: About the WATCHMAN procedure *Procedure success defined as successful delivery and release of a WATCHMAN FLX Device into the LAA. †Occurrence of one of the following events between the time of implant and within 7 days following the procedure or by hospital discharge, whichever is later...
Patient Characteristics: Average CHA2DS2-VASc of 4.2±1.5, Average HAS-BLED of 2.0±1.0 Post Implant Drug Regimen: NOAC/ASA for 45 days, Clopidogrel/ASA to 6 months, ASA post 6 months Primary Safety Endpoint: All-cause death, ischemic stroke, systemic embolism, or device- or procedure-relat...
A substantial proportion of all device migration or embolization cases occur after discharge and different patient and procedure characteristics are associated with in-hospital versus post-discharge cases. Given the morbidity and mortality associated with device migration or embolization, risk mitigation ...
A few months later, I went for another CT scan, and they found, again, the tumor was back in the pulmonary artery, but this time, no doctor wanted to operate on me. A third open-heart procedure is very dangerous. They estimated more than 50% likelihood I would die on the table, wh...
the device surface. Data across several of these preclinical studies demonstrated that the polymer coating provided an 86% reduction in inflammation three days following the procedure, a 70% reduction of thrombus at 14 days and a 50% increase in endothelial tissue coverage 45 days post procedure....
These related to a high initial rate of pericardial effusions and procedure-related strokes. The PREVAIL trial was therefore conducted to give more information on safety and to confirm the efficacy results shown in PROTECT-AF. The PREVAIL trial enrolled 407 patients from 41 US centers who were ...
“The robust clinical evidence and successful commercial outcomes of the WATCHMAN device to-date reinforce the value of this procedure for all appropriate patients.” The company has commenced a limited market release of the new device in Europe, with plans for expansion of the commercialisation in...