Edwards Lifesciences Corp. (NYSE:EW) landed CE Mark approval in the European Union for its Intuity valve system.
The Intuity valve, made of bovine pericardial tissue, is a minimally invasive option for patients in need of aortic valve replacement.
"Minimally invasive therapies are increasingly being sought by patients because of their demonstrated benefits," Dr. Michael Borger, study investigator and associate director of the department of cardiac surgery at the Leipzig Heart Center in Germany, said in prepared remarks. "This system includes unique features designed to facilitate a faster and more efficient procedure, so physicians have the opportunity to provide patients a desired therapeutic option without added procedural complexity."
The news hasn’t generated much love on The Street, where EW share prices were down about 2% to $75.68 as of 10:45 a.m. today.
The CE Mark approval notches another win for Edwards, who landed FDA clearance for its Sapien transcatheter aortic valve replacement system in November.
The Intuity system is not yet cleared for the U.S. market.
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