By Bill Berkrot
Oct 25 The U.S. Food and Drug Administration has
approved Abbott Laboratories' MitraClip medical device,
used to stop heart valve leakage in patients deemed unable to
endure valve repair through open heart surgery, the company said
The MitraClip treats mitral regurgitation, a condition in
which the mitral valve of the heart does not close properly,
causing blood leakage that can lead to stroke, heart attack or
It has estimated the disorder affects about one in 10 people
aged 75 and older.
Those with the condition who are too frail for open heart
surgery are typically treated with medicines and have high rates
of heart failure and rehospitalizations.
"We think longer term in the U.S., (MitraClip) could be a
$500 million product," said RBC Capital Markets analyst Glenn
Novarro. "This approval is sooner than we thought. It's a
Novarro said the timing of the FDA green light was excellent
as it came just ahead of a major U.S. medical meeting for
interventional cardiologists where Abbott will be able to
showcase the device.
A panel of advisers to the FDA in March voted 5-3 to
recommend approval of the implantable heart device. Some panel
members questioned whether MitraClip would be effective.
The MitraClip was approved in Europe in 2008 under a system
in which medical devices often reach the market several years
ahead of the United States..
International sales are running at about $30 million a
quarter, with sales growth at about 50 percent over 2012, Abbott
U.S. sales are likely to grow slowly at first as the company
seeks reimbursement for the device, primarily from the Medicare
healthcare program, and as more physicians are trained in its
use. The MitraClip is implanted using a minimally invasive
procedure in which it is threaded by catheter through a vein
into place in the heart to stop the leak.
There are currently 50 centers in the United States that
have experience with the device through clinical trials. That
number is expected to double over the next year, John Capek,
Abbott's head of medical devices, said in an interview.
There are 20,000 to 30,000 patients in the United States who
would likely qualify for MitraClip implantation, Capek said.