FDA Advisory Committee Votes Favorably on MitraClip
Published date : 21 March 2013
Article date : 21 March 2013
PR Newswire reports that Abbott Vascular has issued a press release announcing that the FDA's Circulatory System Devices Panel has voted by majority of 5 to 3 that the benefits of treatment with the MitraClip device outweigh its risks in patients with significant symptomatic mitral regurgitation (MR).
Abbott's MitraClip device received the CE Mark in 2008 and is an investigational device in the United States.
On a separate question of whether there is reasonable assurance the device is safe - the panel were in unamimous agreement. On the question of whether there is reasonable assurance of efficacy, 4 of the panel were in favour and 5 were not.
The FDA will now take the panel's advice into account when making its decision on whether to approve the MitraClip for the treatment of significant MR in the US, later this year.
Source: PR Newswire, 20 March 2013
