June 16 Edwards Lifesciences Corp said on Monday that U.S. health regulators approved its next generation heart valve replacement system for high risk patients and those deemed too frail to endure open heart surgery.
The Food and Drug Administration approved the Sapien XT transcatheter aortic valve replacement (TAVR) system, Edwards said, adding that it will make the device immediately available to patients with severely diseased aortic valves.
U.S. physicians had long been waiting for the updated version of the original Sapien as the XT employs a smaller, potentially easier to maneuver, catheter than its predecessor.
The XT has been available since 2010 in Europe, where medical devices tend to receive much swifter approvals than in the United States.
Wall Street has also been looking for this approval as the XT is seen as crucial for competing with Medtronic Inc's CoreValve, which uses a smaller catheter than the original Sapien.
"Over the last few months, investors have anxiously awaited the U.S. approval of Edwards' second generation transcatheter valve, Sapien XT," JP Morgan analyst Michael Weinstein wrote in a research note on Sunday, questioning the long wait for approval of a system seen as an important growth driver for Edwards.
Medtronic agreed last month to pay $1 billion to Edwards to settle patent infringement litigation, to keep its CoreValve on the U.S. market.
TAVR systems thread the replacement heart valve into place using a catheter, sparing typically elderly patients chest cracking open heart surgery and lengthy hospital stays.
Edwards shares rose 3.6 percent to $81.30 in extended trading from a New York Stock Exchange close at $78.44. (Reporting by Bill Berkrot)