By Bill Berkrot
Jan 17 Medtronic Inc's minimally
invasive system for replacing diseased heart valves won U.S.
approval for use in patients deemed too frail to endure
traditional open heart surgery, the U.S. medical device maker
said on Friday.
The Food and Drug Administration approved Medtronic's
CoreValve system based on U.S. clinical trials in which it was
shown to be safe and effective while demonstrating low rates of
stroke and valve leakage, the company said.
Medtronic and Wall Street analysts had not expected the
approval decision until April, giving the company a head start
on efforts to seize market share from a similar rival product
sold by Edwards Lifesciences Corp. News of the early
CoreValve approval sent Edwards shares down nearly 5 percent.
More than 100,000 people in the U.S. have severe aortic
stenosis with about one-third too ill or frail for open-heart
valve replacement surgery, making them candidates for CoreValve
or the rival Edwards Sapien system.
The systems, in which the replacement valve is threaded into
place through an artery using a catheter - known as
transcatheter aortic valve replacement, or TAVR - spares
patients chest-cracking surgery, cutting down on recovery time.
CoreValve has been available since 2007 in Europe, where it
is not uncommon for medical devices to win approval several
years ahead of the United States.
"We estimate the U.S. TAVR market will be approximately
$450 million in 2014," said Glenn Novarro, an analyst with RBC
"With approval earlier than expected, share loss for Edwards
will likely occur sooner than expected," added Novarro, who sees
Medtronic grabbing 20 percent of the U.S. TAVR market this year,
rising to more than 30 percent by 2016.
But CoreValve's U.S. sales prospects may hinge on further
legal proceedings after a U.S. jury earlier this week found that
the Medtronic system infringes a patent held by Edwards and
awarded Edwards more than $390 million in damages.
Medtronic vowed to appeal the decision and oppose any
request for an injunction. Edwards, meanwhile, said the patent
infringement ruling entitled it to seek increased damages of up
to three times the value of the award.
The FDA approved CoreValve without first requiring an expert
advisory panel to review the device and make recommendations to
"The low rates of stroke and valve leakage with the
CoreValve System - two of the most concerning complications of
valve replacement because they increase the risk of death and
have a dramatic impact on quality of life - set a new standard
for transcatheter valves," Dr. Jeffrey Popma, director of
Interventional Cardiology at the Beth Israel Deaconess Medical
Center in Boston and one of the lead investigators of the
pivotal clinical trial, said in a statement.
The CoreValve uses a smaller catheter than the currently
approved Sapien, giving it a potential but temporary competitive
edge. Edwards is awaiting U.S. approval of a next generation
Sapien with a similarly smaller catheter.
Both companies are also testing their systems in less high
risk patients in hopes of broadening the potential patient
population and market for the devices.
Medtronic shares were up 18 cents at $59.29 in afternoon
trading, while Edwards shares were off $3.49, or 4.8 percent, at
$69.18, both on the New York Stock Exchange.