June 12 Medtronic Inc said on Thursday
its minimally invasive heart valve replacement system received
U.S. approval to treat patients deemed at high risk for surgery,
expanding the eligible patient population for its CoreValve
CoreValve won initial U.S. approval in January for use in
patients with severe aortic valve disease deemed too frail to
endure traditional open heart surgery, so-called extreme risk
The expanded approval follows results of a pivotal clinical
trial that demonstrated less ill high risk patients fared better
with the CoreValve transcatheter aortic valve replacement (TAVR)
after one year than those who had heart valves replaced via open
CoreValve competes directly with the Sapien TAVR system from
Edwards Lifesciences Corp. Medtronic agreed last month to
pay $1 billion to Edwards to settle patent infringement
litigation, keeping CoreValve on the U.S. market.
The TAVR systems, which use a catheter to thread the new
valve into place, sparing patients chest cracking surgery, are
seen as important growth drivers for both companies.
The U.S. market for TAVR procedures is expected to top $500
million this year and double in size by 2018, Jefferies analysts
"With this approval, we can treat more patients due to the
broad range of CoreValve sizes, and we have an option compared
to surgery that provides a greater chance for a longer life
while minimizing the risk of stroke," Dr. David Adams, one of
the lead investigators of the pivotal U.S. clinical trial from
Mount Sinai Hospital in New York, said in a statement.
Patients suffering from severe aortic stenosis tend to be
elderly, often 80 or older.
(Reporting by Bill Berkrot. Editing by Andre Grenon)