March 18 Staff reviewers for the U.S. Food and
Drug Administration did not recommend the approval of Abbott
Laboratories' implantable heart device MitraClip, citing
a lack of "valid scientific evidence" of safety and
FDA reviewers said in briefing documents, posted on the
regulator's website on Monday, that approval of the device would
not be appropriate at the time as major questions of safety,
efficacy and overall benefit-risk profile remained unanswered.
The device is being tested to treat mitral valve
insufficiency - a disorder where a heart valve does not close
properly when the heart pumps blood, causing blood to flow back
into the heart - in patients considered high risk for open
The device is inserted into the blood stream using a
"The FDA staff is asking for more information. Abbott is
conducting multiple trials on MitraClip, including the COAPT
study, and the staff would want to look at that data," BMO
Capital Markets analyst Joanne Wuensch said.
The COAPT trial is testing the device in high-risk
inoperable and high-risk mitral valve patients. Abbott has also
recently developed a European trial for the patient population.
Abbott had changed the proposed use for the device after the
FDA expressed concerns that there was a lack of evidence to
support its approval for a broader use in patients with
significant mitral valve insufficiency, the reviewers said in
the documents. ()
"FDA firmly believes that the currently enrolling COAPT and
European trials are well-designed trials that will help to
answer the many important questions posed by the very limited
data analyses presented in this (approval application)," the
However, the reviewers recommended that MitraClip continue
to remain available to high-risk patients as an investigational
device so that Abbott can conduct its trials in an optimal
"The MitraClip device represents a true advance for
(high-risk) patients and we look forward to discussing the
totality of the clinical evidence with the advisory committee
members and hearing their recommendations on Wednesday," Abbott
said in an emailed statement to Reuters.
An advisory panel of independent experts will discuss the
data submitted by Abbott on the device and will vote on its
safety, efficacy and risk profile.
BMO's Wuensch said her earnings estimate on Abbott did not
include any expected revenue from MitraClip, adding that she
believed the Street consensus also excluded any potential sales
from the device.
Abbott shares were down 1.2 percent at $33.72 on the New
York Stock Exchange on Monday.