Tag:
Sapien
Latest Headlines
Latest Headlines
Medicare to cover Edwards' Sapien heart valve
For medical device companies, gaining Medicare reimbursement for surgical procedures involving their implants can be a sort of financial holy grail. Edwards Lifesciences ($EW) has reached that point now that the Centers for Medicare & Medicaid Services has agreed to pay for surgery involving its Sapien transcatheter heart valve.
Expanded use for Edwards' Sapien heart valve faces FDA delay
Edwards Life Sciences' Sapien transcatheter heart valve pulled in $41 million in sales during the company's fiscal 2012 first quarter--the first full quarter the device has been on the market since gaining FDA approval in November.
Edwards seeks wider use for Sapien heart valve
Edwards Lifesciences ($EW) wants the FDA to approve its Sapien transcatheter heart valve implant for a broader class of patients.
Medtronic sees positive results with CoreValve
New data presented over the weekend at the European Society of Cardiology Congress 2011 show that Medtronic's ( $MDT ) CoreValve transcatheter aortic valve replacement system maintained its structural
FDA panel votes in favor of Sapien valve
The FDA's Circulatory System Devices Committee gave Edwards Lifesciences ( $EW ) a win Wednesday with a vote recommending the devicemaker's Sapien transcatheter heart valve after an epic session. The
FDA sees promising Edwards valve as safe, effective
An FDA report released Monday showed that Edwards Lifesciences' Sapien heart valve, which can be implanted without major surgery, significantly reduced rates of death versus standard therapy in
