Edwards Lifesciences ($EW) has snagged FDA approval for its minimally invasive aortic valve system, two years after securing a CE mark for the device.
Requiring smaller incisions and just a few sutures, Edwards’ Intuity Elite valve system facilitates implantation during surgical aortic valve replacement. The system comprises an expandable balloon frame and a pericardial platform, allowing better flexibility and visibility through small incisions during the procedure.
Because it is less invasive, many aortic stenosis patients undergoing the procedure face less trauma, less need for blood transfusions and earlier recovery, said Dr. Mubashir Mumtaz, chief of cardiothoracic surgery and surgical director of the structural heart program at PinnacleHealth in Harrisburg, PA, in a statement.
The FDA nod comes on the strength of an 839-patient trial that took place in 29 U.S. centers. The data showed that one year post-procedure, the system was safe and effective. It may also reduce the time it takes to clamp the aorta as well as the amount of time spent under cardiopulmonary bypass during the procedure, according to the statement. These improvements may lead to less time spent in intensive care and in hospital.
"Many patients with aortic stenosis have more than one type of heart disease, most commonly coronary artery disease. The Edwards Intuity Elite valve system enables surgeons to streamline concomitant procedures, which can be beneficial for patients undergoing these longer, more complex surgeries," said Dr. Kevin Accola, program director at the Florida Hospital Cardiovascular Institute’s Valve Center for Excellence in Orlando, FL, in the statement.
In the interim between Intuity’s CE and FDA approvals, British LivaNova ($LIVN) won an FDA approval for its competing sutureless aortic valve, dubbed Perceval. It also beat Intuity to the CE mark, receiving that in 2011 and an expanded indication to include adults under 65 in 2014.
- read the statement
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