St. Jude Medical on Monday announced the European approval of its Portico transcatheter aortic heart valve, which allows doctors to treat severe aortic stenosis for inoperable or high risk patients without open heart surgery.
With the announcement, St. Jude joins a growing roster of companies that are making a less-invasive way to treat what is a very dangerous disease. Aortic stenosis is a narrowing of the aortic heart valve that decreases blood flow from the heart. Before the advent of transcatheter aortic valve replacement (TAVR), the only way to replace a diseased aortic valve was through open heart surgery. Problem was, some patients are deemed too sick for open heart surgery to risk it.
But, without valve replacement, as many as half of those with severe aortic stenosis die within a year.
Transcatheter valve replacement allows doctors to insert a new valve into the heart by snaking a catheter up into the patient through an artery in the leg. Patients can be home from the hospital within a couple of days, instead of weeks after open heart surgery.
Currently, only Edwards Lifesciences, based in California, has the only transcatheter valve approved for sale in the United States. Medtronic is currently marketing its own TAVR product in Europe and expects to gain U.S. approval in 2014. Boson Scientific also is developing a similar product, which is expected to win European approval in late 2013.
St. Jude’s Portico valve can be resheathed and repositioned – or withdrawn – before it is released from its delivery system, allowing physicians more flexibility in placing the valve and preventing possible leakage around the valve, St. Jude said.