There has been a decade long research work, experiments, rocky data releases, various regulatory rejections; however, after all these meticulous hassles, the Watchman atrial device that works towards stroke risk reduction in cases of severe non-valvular atrial fibrillation, has been approved for rampant use by the US FDA.
Indeed this atrial appendage closure instrument or device is the first-of-the-kind product and alternative to warfarin, that has been in vogue over quite some time. The device can be used by individual suitable candidates who aim for warfarin and have rationale to seek some non-pharmacologic alternative to this warfarin.
Centres Get Access
However, the announcement that was made did not spell out the premise of rationale, just as was necessary. Centres that have dealt with transcatheter delivery processes of various devices through procedural and clinical studies will eventually get access; the availability spreading out to additional specialized centres as well. Physicians who would deal the technique were trained on this product and procedure.
Eligible Patients
Patients eligible to undergo this process would be shortlisted on the basis of elevated thromboembolic risk scores after evaluating or weighing the safety concerns and effectiveness pertaining to this device in comparison to warfarin.
Over The Past Years
The approval came after receiving a detailed procedural approval vote by a FDA advisory committee. In 2014, the votes came 7-6 in favour of the approval, especially on the premise of efficacy. In 2009, there was an approval 7-5. PROTECT-AF trial however showed noninferior efficacy, however far more bleeding and having intrinsic complications.
In 2013, committee carried out subsequent PREVAIL trials, wherein votes came 13-1 in favour of the product approval. However, issues pertaining safety and prevention of non-inferiority endpoints effaced, hence the deal was scraped from realizing the concept.
Meta-analysis of both the trials put together favoured warfarin in ischemic stroke protection. However, on the current premise this product has better preventions from strokes; chances of haemorrhagic stroke would reduce.