Edwards Lifesciences (NYSE:EW) announced today that it won CE Mark approval in the European Union to market its next-generation INTUITY Elite aortic valve.
The INTUITY Elite device can be surgically implanted via smaller incisions than its predecessors, from which it borrows parts of its design, Edwards said. The new valve is based largely on the company’s PERIMOUNT platform, adding a features to facilitates rapid deployment and provide enhanced visibility through smaller incisions.
"We’ve enhanced the EDWARDS INTUITY design to further meet the needs of patients, physicians and hospitals with a valve and procedure that can be readily incorporated into the surgeon’s treatment offerings," Edwards heart valve therapy vice president Donald Bobo said in prepared remarks. "We believe the EDWARDS INTUITY platform can greatly expand the population of patients who receive the less-invasive approach with important clinical and cost benefits."
The company plans to make the device available immediately to "hospitals throughout Europe that recognize the CE Mark," Edwards global communications director Steve Chesterman told MassDevice.com today.
Edwards touted the new device during recent surgical conferences, including the 2014 Annual Meeting of the Society of Thoracic Surgeons. The company presented clinical trial results that showed that the new valve resulted in a 24% reduction in surgical ischemic time, the period in which blood flow to and from the heart is stopped, when compared with traditional valve surgery.
The INTUITY Elite also produced better results in patient blood flow and hemodynamics 3 months following surgery, according to an Edwards press release.
EW shares were up 0.6% in late morning trading today, going for $75.63 apiece as of about 11:40 a.m.
Updated April 4, 2014, at 11:45 a.m. with comments from Edwards.