There was an update today on the long-awaited FDA status of Atritech’s WATCHMAN® device. If approved, it would provide an alternative to taking Coumadin or warfarin to prevent strokes for those with atrial fibrillation.
Here are some quotes from the press release.
Minneapolis (March 18, 2010) — Atritech, Inc., an emerging medical device company, announced today that it has obtained clarity from the U.S. Food and Drug Agency (FDA) on the regulatory path towards full approval of its WATCHMAN® Left Atrial Appendage (LAA) Closure Technology in the United States.
In a recent letter received from the FDA, the agency requested that a confirmatory study be conducted to further substantiate the safety and effectiveness of the WATCHMAN® LAA Closure Technology in patients with atrial fibrillation at risk of stroke and eligible for anticoagulation therapy. Atritech will be working closely with the FDA to finalize the study design and is looking to start the confirmatory study later this year.
Also mentioned in the press release was the presentation this week at the American College of Cardiology meetings of data related to the WATCHMAN®.
Earlier this week, American College of Cardiology’s (ACC) President-Elect Dr. David Holmes, presented 1350 patient years of follow up data from the PROTECT AF clinical trial at the annual ACC meeting in Atlanta. Highlights of the data include a 31% risk reduction in all stroke, cardiovascular death and systemic thromboembolism [blood clots] in the WATCHMAN group as compared to patients on Warfarin. The results presented were comparable to those presented in the initial data published in The Lancet, August 2009.
It’s good to find out where this stands with the FDA as it has been nearly 11 months since the FDA Advisory Committee voted 7-5 in favor of recommending approval. The small study size and safety concerns were at issue, and this announcement clarifies what is still needed for FDA approval.
For more information and background about the FDA’s review of the WATCHMAN device, read: Watchman Device as Alternative to Warfarin or Coumadin – Updated 4/24/09
I would like to have the procedure to reduce the risk of stroke and to allow me to participate in activities that could lead to extreme bleeding while on coumadin. I bicycle and any head impact could cause subdural hematomas.
And the Road Rash could cause bleeding and bruising.
Thanks, Don Hall
I have read all the info on the watchman has it or has it not been approved by fda i don’t want to start on blood thinners they are as dangerous as any device, the doctors
don’t care if there is a natural blood thinner i have used horse chestnut for 10 years and had protimes done periodalically and always have a good rating i recently underwent heart cath and according to the surgion my arteries are “pristine” my heart doctor told me i have the most perfect cholestrol levels she has seen and i use herbs for that too milk thistle..but they still want me to take dangerous blood thinners..
Ann,
The WATCHMAN has not been approved by the FDA. It is applied by a catheter. There is a device applied in surgery, called the AtriClip, that has been approved by the FDA. But, it still requires surgery, so it’s best to have it applied when having surgery for afib.
Protimes only measure the results from Coumadin or warfarin, so I don’t understand why they are doing protimes on you if you’re not on either of those drugs.
Can you share why you consider blood thinners to be dangerous? Usually it’s bleeds that folks are concerned about, but the recent European Society of Cardiology guidelines for afib state that you’d have to fall about 300 times for the risk of a bleed to outweigh the risk of a stroke. The article below has more info on that and info on where to find that in the ESC guidelines.
Facts for those with afib: New ESC Guidelines Provide Leading-Edge Atrial Fibrillation Treatment Guidance
Mellanie
I recieved a Watchman implant on Tuesday the 12th of April 2011 and am now waiting in anticipation of positive results. I am hoping that it will result in my not only being able to come off the warfarin medication but also the other heart medications that I have been on for a the past 18 years.
I had an rf ablation last January to correct WPW syndrome as well as reduce my afib. I was put on a coumadin regimin to reduce risk of clots. This was done at the Mayo Clinic in Rochester, MN.
I continue to have some afib symptoms, but a holter monitor showed none for a two-day period a few weeks back. (Since my afib has always been paroxysmal I don’t know if that eliminates the possibility that I still have episodes.)
Meanwhile, I started to get severe “cough headaches” on the left side of my head. Since I have never had headaches, I decided it was time to see my internist. He thought I should get a brain scan and he had me undergo a MRA. The scan disclosed a subdural hematoma. The Neurologist who read the results said that most of the blood was old, but some also appeared new. He immediately took me off coumadin, saying it the danger from a hematoma was greater at this point than the risk of a clot from my atria.
I’m more than a little concerned about both conditions, and want to make sure I am getting good advice. I do have a call in for my cardiologist.
What would you suggest?
John,
I’m so sorry. Have you heard back from your cardiologist, and what did he suggest?
Mellanie
Are people that have already had CVA’s candidates?
Be very careful about the Watchman implant, my Brother had the procedure done about a year ago and was taken off Coumadin, he had a major stroke in July 2011 and the doctors put him back on Coumadin, this has destroyed his life !!!
Hans,
I’m so sorry about what happened to your brother.
Mellanie
Has the Watchmen device been approved yet by the FDA, and more importantly does Medicare cover it? Can anyone give me the answer to this? Thanks.
Brooklyn108,
No, the WATCHMAN is not FDA approved. The FDA has required an additional clinical trial before reviewing it again.
Mellanie
Hi Melanie, thank you for the info. I am going to be seeing Dr.. Vivek Reddy in NYC this summer for a second ablation. He didn’t do the first, but I hear he is expert in the field of persistent A-Fib. It says on his website that he does the Watchman. I guess I’m questioning why a handful of doctors are doing it if it isn’t FDA approved. I’m hoping this time is a charm, because I’m traveling across the country to see him.
Thank you for the info,
Brooklyn
Brooklyn108,
Dr. Reddy leads the WATCHMAN clinical trial, so he can implant the WATCHMAN as part of the clinical trial. Others who are not part of the trial cannot do so.
You’d need to ask Dr. Reddy about Medicare coverage for it as that varies from trial to trial.
Mellanie
Thank you so much, Melanie. I do believe he’s my last hope at a normal life. the fatigue and dizziness are taking it’s toll on me, and I’ve tried everything possible to rid myself of the atrial fibrillation. Dr. Reddy is my last hope, but he deals with persistent a-fib. I didn’t realize he led the Watchman trial when he mentioned it to me to be honest. I’m assuming he is one of the best, because my Sister swears by him. Wish me luck. If he can’t do the Watchman, perhaps at least he can rid me of the A-fib. That in itself would make all the difference in the world to me.
Brooklyn108,
Dr. Reddy is quite an innovator. I’m glad your sister has such great words to say about him. Many folks have been very happy with his results for them. Good luck.
Mellanie
Thanks Melanie. I don’t think I would be a very good candidate for the trial though as I’m across the country, and I would think he wants the people to live in NYC (which used to be home) where he can keep track of what is going on. The fact that I’ve heard nothing but good things gives me a lot of hope, and the fact that he has taken time out of his busy schedule to personally keep in touch with me makes me think he’s a very compassionate doctor. I’m definitely looking forward to meeting him. Thanks again.
Watchman device has fda approval, When will Medicare & Medicaid QMB cover it and what hospitals in Indiana & Eastern Ohio will be doing this procedure?
The FDA’s Advisory Panel voted last December to recommend that the FDA should approve the Watchman, but so far, the FDA has not approved it.
When will this be approved or is it still I trail????? Compared to the Lariat/ or Wolf Mini-Maze are these approved or in trial???