Earlier this month Abbott Labs was sounding bullish about its prospects for the MitraClip device as it faced its FDA PMA review. However, the advance materials are not recommending the approval of the implantable heart device at today’s meeting, citing a lack of “valid scientific evidence” of safety and effectiveness.
The outcome from the FDA’s review of MitraClip will not known until later today, but the agency did its usual thing of issuing notes as advance meeting materials. These can be found here.
You can of course read the entire document (87 pages) at your leisure, such is the transparency with which the agency operates. Jumping straight to the recommendations however, it seems the FDA’s staffers who put this together feel the submission falls short in terms of valid scientific evidence of safety and efficacy for its proposed indicated use in patients with inoperable mitral valve regurgitation.
The bottom line seems to be that while Abbott has been reporting favourable results from its own Everest II study into mitral valve regurgitation treatment in a population considered too high risk for conventional surgery, FDA is holding out for the completion of the COAPT and European studies.
Specifically, FDA’s notes say it cannot determine that in a significant portion of the target inoperable population, the use of the device as proposed, will provide clinically significant results without a valid comparator group. The Everest II study did not have such a group. COAPT does.
What’s interesting is that the device has been available in Europe for five years. The contrast between the regulatory regimes remains staggeringly stark, doesn’t it? And as for which one is right, that’s another matter for conjecture, but what is interesting from European data is that the MitraClip device, where available, is being reserved for the sickest patients, rather suggesting that physicians are quite good at establishing efficacy and effectiveness for themselves.
Source: U.S. FDA