FDA Panel Recommends Approval of Atrial Fibrillation Therapy
Last week, an FDA advisory panel recommended that the FDA approve the Watchman device. However, the vote of the panel was only 7-5, and occurred only after a day-long spirited debate, in which some panel members expressed strong concerns that longer-term studies should be required in order to truly assess the safety of the device.
Members of the panel who voted in favor of approval referenced the difficulty in using Coumadin safey and effectively, and felt doctors and patients should be offered this alternative.
The FDA will now consider the recommendation of the advisory panel, and likely within a few months will come to a formal decision about market release for the Watchman device. The FDA usually, but not always, follows the advice of its panels. If the device is approved, its usage will come with several conditions, including limiting the number of medical centers allowed to implant it, and requiring a formal certification program for physicians who want to implant it.
Read more about the Watchman device, and the results of the PROTECT-AF study, here.
Comments
I have not been at either end of a cardiac catheter so my personal experience context is below limited but these comments http://content.onlinejacc.org/cgi/content/full/50/9/914regarding the watchman occluder would make me think twice about letting someone put that in me.Any thoughts?
In my view the current data shows this device is a feasible alternative, but I would want a lot more information about short- and long-term complications (especially when implanted by “regular” cardiologists) before I would consider it.
I having been through so many diffrent procedures would not recomend to any one, trying anything new. First I was told stints were the answer, after having over 15 stints insertd, which ment way to many hearty cathes I got tired of letting that dr just do stint after stent, sometimes I would have a new stint for less then a week and be back for a new one, changes drs. His solution was a cabbage, had that got along for about 5 years now back to same old thinks had a heart attack in middle of stinting, did work up for heart transplant, turned out not to be sutible for heart transplant, got a defibulator,pacemaker which is helping some, only 63 just waiting to die.
I would like to know if anyone has had a serious side effect from the drug AMIODARONE, 100mg,for A/FIB and how long you are/were on the drug [100MG]
First, considering the side effects of chronic coumadin therapy and the latest news/research on the Watchman Device, I think this is a very promising option for those with afib. Second, I am sorry to hear of your troubles with what appears to be very aggressive coronary artery disease. Don’t lose hope Sharen. And finally, while Amiodarone does have a very serious side effects profile, any good cardiology/EP doctor worth his salt will have any amio patients closely monitored for these adverse effects (getting lung scans and such on a scheduled basis). I have known some patients that did have to stop therapy due to pulmonary issues, among some other side effects. Some had been on the drug for a less than a year, others for several. Amio affects each patient very differently! Some I know have never had a single issue with it.