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 device.
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 patients.
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 heart surgery.
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 forecast.
"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)