Release date: 2015-03-17
Boston Scientific announced that the FDA has approved the Watchman left atrial appendage occlusion device.
The company said that for patients with non-valvular atrial fibrillation (high risk of stroke and systemic embolism), the device can be used as an alternative to warfarin to reduce the risk of thromboembolism. Its function is to prevent the movement of blood clots by closing the left atrial appendage.
The FDA approval was based on the results of the Watchman clinical study, which included data from more than 2,400 patients (about 6,000 patient-year follow-up). The most powerful test results (from PROTECT AF and PREVAIL) indicate that the device is safe and effective compared to warfarin therapy. In December 2011, the FDA's Circulatory Systems Equipment Panel voted 13:1, arguing that the benefits of Watchman equipment for patients were greater than their potential risks.
The second vote in October 2014 was divided: the experts voted 12:0 and considered the device to be safe; 6:7, the device was considered invalid; 6:5, and the benefit was greater than the risk. However, the panel finally agreed that the device should be used for second-line treatment in some patients.
According to the company, the device will be used for patients who are eligible for warfarin therapy but who are seeking non-pharmacological treatment for reasonable reasons.
Dr. Vivek Y. Reddy (Head of arrhythmia service at Mount Sinai Medical Center, co-investigator of PROTECT AF and PREVAIL trials) said: We know that more than 40% of patients who should take oral anticoagulant therapy cannot take oral antibiotics for various reasons. Clot treatment, which highlights the importance of other treatment options. The device is a breakthrough therapy that allows patients who require warfarin to choose implantable equipment to reduce the risk of stroke while avoiding long-term warfarin.
In 2009, the equipment has been internationally listed. With the approval of the FDA, medical centers in the United States will also begin to use this device in clinical trials, and when doctors receive implant training, it will be introduced to others.
Source: Medical Pulse
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