By Joseph Walker
Medtronic Inc. received U.S. regulatory approval to sell its
minimally invasive heart valve technology for patients too frail
for traditional surgery, the medical device maker said Friday.
The U.S. Food and Drug Administration granted approval for
CoreValve, used to replace damaged aortic valves, three months
earlier than Medtronic had previously forecast. The approval allows
the Minneapolis-based company to begin competing against rival
Edwards Lifesciences Corp., whose similar device, called the
Sapien, was first approved in the U.S. in 2011. The Sapien has
since been approved for a wider range of patients, including those
who are eligible for surgery, but who are considered at high risk
for complications.
The CoreValve is approved for patients with severe aortic
stenosis who are too sick or frail to undergo open-heart surgery,
which is considered the standard of care for most patients. In a
clinical trial, patients receiving the device had a 25.5% rate of
death or major stroke after one year, compared with an estimated
rate of 43% had the patients received medication therapy.
The technology, called transcathether aortic valve
replacement--or TAVR--is used to implant new valves through a
catheter tube inserted into a patient's artery. It is a
less-invasive method compared with open surgery, which can be
traumatic. However, open surgery is still considered the safest and
most effective option for patients who can withstand it because of
TAVR's increased risk of stroke and other complications.
Shares of Edwards Lifesciences fell 3.9% to $69.82 in midday
trading on the New York Stock Exchange, with investors surmising
that the early approval will allow Medtronic to take even more
market share away from Edwards than previously estimated. The stock
is down 23.6% over the past 12 months, hurt by disappointing U.S.
sales of the Sapien. The company estimates that world-wide TAVR
sales will be in a range of $700 million to $820 million in
2014.
Write to Joseph Walker at joseph.walker@wsj.com
Subscribe to WSJ: http://online.wsj.com?mod=djnwires